A Review UV Method Development and Validation

 

Komal P. Shinde, Akash D. Rajmane*

Department of Pharmaceutics, D.S.T.S Mandal’s College of Pharmacy, Solapur 413004, Maharashtra, India.

*Corresponding Author E-mail: akash.rajamane4416@gmail.com

 

ABSTRACT:

Ultraviolet spectroscopy is one important and advanced analytical instrument in the Pharmaceutical industry and used for the last 35 years. The method of analysis is based on measuring the absorption of monochromatic light by colorless compounds in the near-ultraviolet path of the spectrum (200-400nm). The pharmaceutical analysis comprises the procedures necessary to determine such compounds' “identity, strength, quality, and purity”. It also includes the analysis of raw materials and intermediates during the manufacturing process of drugs. The fundamental principle of operation of a spectrophotometer covering the UV region consists that light of a definite interval of wavelength passes through a cell with solvent and falls onto the photoelectric cell that transforms the radiant energy into electrical energy measured by a galvanometer. Ultraviolet-visible spectroscopy is used to obtain the absorbance spectra of a compound in solution or as a solid.

 

KEYWORDS: UV, Method Development, Validation, ICH guidelines, Assay, Review.

 

 


INTRODUCTION:

Pharmaceutical analysis is essential in the process of quality control as well as quality assurance of pharmaceutical chemicals and their formulations. It provides information on the identity, purity, content, and stability of starting materials, excipients, and active pharmaceutical ingredients. It also ensures the safety, efficacy, and quality of pharmaceutical products used for therapeutic purposes. Analytical methods are intended to establish the identity, purity, physical characteristics, and potency of the drugs that we use. Methods are developed to support drug testing against specifications during manufacturing and quality release operations and during long-term stability studies. It may also support safety and characterization studies or evaluations of drug performance.1-2

 

Figure 1.1: Block Diagram of Typical UV Setup

 

A ‘regulatory analytical procedure’ is used to analyze a defining characteristic of the raw materials, active pharmaceutical ingredients, and pharmaceutical formulations in the pharmaceutical sectors. Now a day, methods of interest for quantification or estimation are sophisticated analytical methods, that is UV, HPLC, GLC, and HPTLC, which are generally used for routine or laboratory purposes. Chromatographic methods are mainly used for the qualitative and quantitative estimation of drug substances, drug products, and raw materials throughout the drug development, from the initial stage of research to the release of drug products. The sophisticated analytical methods are simple, effective, and robust for the estimation of raw materials, active pharmaceutical ingredients, and pharmaceutical formulations.

 

Nowadays, new analytical method development is a need for a routine exercise for the analysis purpose due to its advantages over the non-instrumental methods. Analytical methods are generally classified into two categories:

·       Instrumental

·       Non-Instrumental

 

Initially, the methods were based on simple titrations and different qualitative reactions characteristic of the analyte, but in these ways, human errors were always there, and the efforts were continued to minimize these errors. The resultant outputs of these efforts are different analytical instruments having fewer chances of human error as the human eyes are replaced by highly automated detectors.2

 

The Pharmaceutical analysis can be done with various methods, which are classified in this Fig. 1.2.


 

Figure 1.2: Various Analytical Methods for Analysis

 


Analytical chemistry can be divided into two general areas of analysis.

·       Quantitative: It means how much quantity of active analytes is present.

·       Qualitative: It means which active analytes are present.3

 

UV-Visible Spectroscopic Methods:

Spectrophotometric techniques are used to measure the concentration of solutes in solution by measuring the amount of light that is absorbed by the solution in a cuvette placed in the spectrophotometer. Spectrophotometry takes advantage of the dual nature of light.

·       Particle nature which gives rise to the photoelectric effect.

·       Wave nature which gives rise to the visible spectrum of light.

A spectrophotometer measures the intensity of a light beam after it is directed through and emerges from a solution.

 

For analysis of these drugs, different analytical methods are routinely being used. One of the most exploited methods for the analysis of drugs is spectroscopy; which may be defined as a method of analysis that embraces the measurement of absorption by chemical species of radiant energy at definite and narrow wavelength, approximating monochromatic radiation.4

 

Beer’s LAW:

It states that the intensity of a beam of parallel monochromatic radiation decreases exponentially with the number of absorbing molecules. In other words, absorbance is proportional to the concentration.5-6

 

Lambert’s LAW:

It states that the intensity of a beam of parallel monochromatic radiation decreases exponentially as it passes through a medium of homogeneous thickness. A combination of these two laws yields the Beer-Lambert law.5-6

Beer’s –Lambert’s LAW:

At the point when light emission light is permitted to go through a straightforward cell containing an arrangement of engrossing substance, lessening of the power of lightmay occur; the rate of reduction in intensity is proportional to the thickness of the mediumand concentration of absorbing substances”

 

Mathematically Beer-Lamberts law is expressed as:

where,

A = ab c

A = absorbance or optical density

a = absorptivity or extinction coefficient

 

Quantification of medicinal substances using a spectrophotometer may be carried out by preparing a solution in transparent solvent and measuring its absorbance at a suitable wavelength. The wavelength normally selected is the wavelength of maximum absorption (λmax), where a small error in setting the wavelength scale has little effect on measured absorbance. Ideally, concentration should be adjusted to give an absorbance of approximately, 0.9, around which the accuracy and precision of the measurements are optimal.

 

The assay of the single component sample, which contains other absorbing substances, is then calculated from the measured absorbance by using one of three principal procedures. They are the use of standard absorptivity values, calibration graphs, and single or double point standardization.7

 

Quantitative analysis by UV-Visible Spectrophotometry:

Single Analyte:8

Quantitative spectrophotometric assay of medicinal substance as a single entity can be done by setting up the answer in straightforward dissolvable what's more, measuring its absorbance at suitable wavelength, most ideally wavelength maxima (lambda max). convergence of retaining substance can be computed from deliberate absorbance utilizing one of three rule methods.

a.     Utilization of standard absorptivity esteem.

b.     Utilization of adjustment chart.

c.     Single or twofold point institutionalization.

 

Multicomponent System:9,10

Spectrophotometric investigation of medications once in while includes the estimation of absorbance of test containing stand out engrossing part. Absorbance from sources other than drugs like impurities, decomposition products, and formulation excipients is termed superfluous absorbance and if not evacuated grants precise lapse to the examination of medication in the test. Several adjustments to the basic spectrophotometric technique described in the previous section for single part tests are accessible to the investigator, which disposes of specific wellsprings of impedance and grants exact determination of one or all of the engrossing segments.

 

Different spectrophotometric strategies accessible that can be utilized for the investigation ofthe sample, such as:

·       Derivative spectrophotometric method

·       Simultaneous Equation method

·       Absorbance Ratio method

·       Absorbance Correction Method

·       Difference spectrophotometry

·       Dual-wavelength spectrophotometry

·       Ratio Spectra Derivative Spectrophotometry

·       Standard Addition Method

·       Area under curve method

·       Chemical Derivatisation method

 

Derivative Spectrophotometric Method11,12,13

Differentiation of spectra is referred to as derivative spectroscopy. The conventional absorption spectrum is a plot of absorbance (A) against wavelength (λ). With the end goal of otherworldly examination keeping in mind investigative circumstances in which mix contribute to meddling ingestion, a strategy for controlling unearthly information is called subsidiary spectroscopy. Subsidiary spectroscopy utilizes first or higher subordinates of absorbance regarding wavelength for subjective investigation and measurement. The idea of derivatizing otherworldly information was initially presented in the 1950s when it was demonstrated to have numerous favorable circumstances.

 

Area Under Curve Method:12,13

The AUC (region under bend) strategy is applicable where there is no sharp peak or when wide spectra are procured. It incorporates a check of joined estimation of absorbance regarding wavelength between two chosen wavelengths λ1 and λ2. Range figuring handling thing ascertains region bound by bend and even pivot. The level hub is chosen by entering the wavelength run over which region must be computed. This wavelength extent is chosen on-the premise of rehashed perception to get linearity between the range under bend and fixation. The alignment bend was developed by plotting fixation versus AUC.

 

Standard Addition Method:13,14

Standard expansion strategies are especially valuable for dissecting complex examples in which the probability of framework impacts is generous. A standout amongst the most widely recognized structures includes including one or more augmentations of standard answers for test aliquots of the same size. This procedure is regularly called spiking example. Every arrangement is then weakened to the settled volume before estimation. It ought to be noticed that when the measure of the test is constrained, standard augmentations can be done by progressive presentations of additions of the standard to a solitary measured volume of obscure. Estimations are made on the first specimen and example in addition to standard after every expansion. In many renditions of standard expansion technique, the example framework is almost indistinguishable after every expansion, the main contrast being centralization of analyte or in cases including expansion of abundance of scientific reagent, the convergence of reagent. Every single other constituent of the response blend ought to be indistinguishable because gauges are arranged in aliquots of the specimen.

 

Ratio Spectra Derivative Spectrophotometry:15,16

The system is in light of isolating range for blend into standard spectra for each of examinations and to acquire range that is autonomous of analyte fixation utilized as the divisor. utilization of institutionalized spectra as divisors minimizes trial slips. The exact decision of standard divisors and working wavelengths is basic for a few reasons. Proportion spectra subsidiary licenses utilization of wavelengths relating to greatest or least furthermore utilization of separation between back to back most extreme and least.

 

Absorbance Ratio Method(Q Analysis Method):17,18,19

The absorbance proportion technique is an alteration of the concurrent mathematical statements system. It relies on upon property that for a substance that agrees to Beer's Law at all wavelengths, the extent of absorbances at any two wavelengths is reliable quality self-ruling of obsession or way length. In USP this proportion is eluded as Q esteem. British Pharmacopeia additionally utilizes the proportion of absorbances at indicated wavelengths in certain affirming tests of personality.

 

In a quantitative test of two segments in admixture by absorbance extent procedure, absorbances are measured at two wavelengths, one being λmax of one of the fragments (λ2) and the other being the wavelength of equal absorptivity of two sections (λ1) that is absorptive. Two equations are constructed from the simultaneous equation method.

 

Fig. 1.3: Wavelengths for assay of substances X and Y in admixture

Application of UV-Visible Spectroscopy:

·       Identification of compounds by spectrum matching with reference spectra

·       Trace analysis of inorganic, organic, and biological species

·       Enzyme assays

·       Monitoring of reaction rates

·       Detector for chromatography

·       Environmental remote sensing

·       Field testing

·       Study of equilibrium systems

·       Trace analysis via reaction rate determination

·       Pharmaceutical determination

 

In UV spectroscopy too, there are different techniques for simultaneous estimation like simultaneous equation method, derivative spectroscopy, absorbance ratio method, difference Spectrophotometry, dual-wavelength method, etc.

 

In the literature review, various articles are available for method development and validation via UV. The present work is therefore focused on achieving the optimum chromatographic parameters covering all the points of method development and validation according to ICH guidelines.20

 

UV Method Development:21,22,23

Day by day number of new drugs is introduced into the market. Frequently, there is a bigger period between the date of presentation of medication into the business sector and the date of its incorporation into pharmacopeias. This happens as a result of conceivable vulnerabilities in nonstop and more extensive utilization of these medications, reports of new toxicities, improvement of patient resistance, and presentation of better medications by contenders. In such cases, standard scientific strategies for these medications may not be accessible in Pharmacopeias. It gets to be fundamental, in this way, to grow a new explanatory system for such medications. Additionally, quality is vital in every item or administration in pharmaceuticals as it includes life.

 

An official analytical method is used to assess characterized normal for medication substance or medication item. option logical technique is proposed by a candidate for utilization rather than the administrative systematic method. Security testing structures imperative piece of the procedure of medication item advancement. reason for soundness testing is to give proof on how the nature of medication substance or medication item differs with time affected by a mixed bag of ecological components, for example, temperature, moistness, and light and empowers suggestion of capacity conditions, retest periods, and timeframes of realistic usability to be set up. The two primary parts of medication items that assume a vital part in the timeframe of realistic usability determination are the test of dynamic medication, and degradants created, amid soundness study.

In brief reasons for the development of newer methods of drugs, analysis is:

·       The medication or medication mix may not be official in any pharmacopeias.

·       A fitting expository method for medication may not be accessible in writing because of patent regulations.

·       Analytical systems may not be accessible for medication as planned excipients.

·       Analytical systems for medication in the mix with different medications may not be accessible.

 

Types of analysis:

1.     qualitative analysis:

The Qualitative analysis identifies the nature of the substance, and if it isa mixture, the nature of the components present.

 

2.     Quantitative analysis:

The Quantitative analysis determines the elemental composition ofthe substance and the quantitative distribution of each component.

 

3.     Structural analysis:

The investigation helps in discovering the spatial plan of ion as in particle andvicinity or position of certain natural useful gathering in a given compound. What'smore surface examination assumes an imperative part in material studies to getsurface-related physical properties, for example, geography, profundity profiling, the introduction of the atom, and so forth.

 

Method Development is Done:24

1.     For new products

2.     For existing products

In brief reasons for the development of newer methods of drugs analysis are:

·       The medication or medication mix may not be official in any pharmacopeias.

·       A fitting expository method for medication may not be accessible in writing because of patent regulations.

·       Analytical systems may not be accessible for medication as planned excipients.

·       Analytical systems for medication in the mix with different medications may not be accessible.

 

UV Method Validation:24,25

Method Validation:

·       Validation is concerned with assuring that a measurement process produces valid measurements;

·       Results from method validation can be used to judge the quality, reliability, and consistency of analytical results. It is an integral part of any good analytical practice.

·       A measurement process producing valid measurements for an intended application is fit for purpose.

 

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability, and consistency of analytical results; it is an integral part of any good analytical practice.

 

Analytical methods need to be validated or revalidated

·       Before their introduction into routine use;

·       Whenever the conditions change for which the method has been validated (e.g., an instrument with different characteristics or samples with a different matrix); and

·       Whenever the method is changed and the change is outside the original scope of the method.

·       Nowadays, there are several internationally renowned organizations offering guidelines on method validation and related topics.

·       American Society for Testing and Material (ASTM)

·        Codex Committee on Methods of Analysis and Sampling (CCMAS)

·        European Committee for Normalization (CEN)

·        Cooperation on International Traceability in Analytical Chemistry (CITAC)

·        European Cooperation for Accreditation (EA)

·        Food and Agricultural Organization (FAO)

·        United States Food and Drug Administration (FDA)

·        International Conference on Harmonization (ICH),

 

Method development and validation are continuous processes that progress in parallel with the evolution of drug products. Changes encountered during drug development may require modifications to existing analytical methods. These modifications to the methods, in turn, may require additional validation. The advent of new techniques and improved instrumentation in the field of analysis may give way to more sensitive, precise, and accurate methods if the existing methods are erratic or unreliable; time-consuming, or too expensive. Thus, continuous new analytical method development and validation activities are essential for the growing drug development programs.

 

Validation of analytical methods means activity or procedures under pre-established criteria which provide documented evidence that a method developed will produce a consistent result, that is linearity, accuracy, precision, robustness, ruggedness, etc.

 

Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, quality, purity, and potency of the drug substances and drug products. Simply, method validation is the process of proving that an analytical method is acceptable for its intended purpose. A successful Validation guarantees that both the technical and regulatory objectives of the analytical methods have been fulfilled.

 

The discussion of the validation of analytical procedures is directed to the four most common types of analytical procedures:

·       Identification tests,

·       Quantitative tests for impurities' content,

·       Limit tests for the control of impurities,

·       Quantitative tests of the active moiety in samples of the drug substance or drug product or other selected components in the drug product.

 

Figure 1.3: ICHAnalyticalmethodsValidationParameter

 

Advantages of Analytical Method Validation:26-27

Method validation builds a degree of confidence, not only for the developer but also for the user. Validation appears costly and time-consuming, but it results in inexpensive, eliminates frustrating repetitions, and leads to better time management in the end.

 

Minor changes in the conditions such as reagent supplier or grade, and analytical setup are unavoidable due to obvious reasons, but the method validation absorbs the shock of such conditions and pays for more than invested in the process.

 

The methods to be developed will be helpful to scientists for routine analysis in Pharmaceutical Organizations by “Q.C Department”.

 

It is referred to all that over long haul more up to date drugs and their details either in single or in consolidated dose structures are figured and advertised. All time the, there is a bigger period between the date of presentation of medication into the business sector and the date of its consideration in pharmacopeias. In this way, it gets to be vital, to grow new diagnostic strategies for such medications.

Analysis of formulation done to gain information about the qualitative and quantitative composition of substance and species, that one can conclude that substance is composed of what and exactly how much. This information is necessary for the development of manufacturing operations and therapeutic action of the drug.

 

Selection of Analytical Wavelength:27

To analyze an appropriate wavelength for determination of drug solution in the mobile phase were scanned in UV- Visible Spectrophotometer within the range of 200- 400nm. The wavelength at which the molecule shows maximum absorption is the analytical wavelength which is called the lambda max of a particular drug.

 

Specificity:28

Specificity is described as the capacity to degree accurately and especially the quantity of analyte of interest in the presence of other additives that are expected to be present within the sample matrix. Specificity is a measure of the degree of interference from such matters. it can consist of different active elements, excipients, impurities, and degradation products, making sure a peak reaction. Specificity is measured through the resolution, plate count, and tailing factor inside the analysis and documented for this reason.

 

For identification purposes, specificity is demonstrated by the ability to discriminate between compounds of closely related structures, or by comparison to known reference materials. For assay and impurity tests, specificity is illustrated by the resolution of the two closest eluting compounds in the sample. The compounds are usually major components or active ingredients and an impurity. If the impurities are present in the sample, it must be demonstrated and proved that the assay is unaffected by the presence of spiked materials which may include impurities or excipients. If impurities are absent, the test results are compared to a second well-characterized and developed procedure. For the assay, the two results are compared. For impurity tests, the impurity profiles are compared.

 

Specificity is measured and documented in a separation by the resolution, plate count efficiency, and tailing factor. Specificity can also be evaluated with modern photodiode array detectors that compare spectra collected across a peak mathematically as an indication of peak homogeneity ICH also uses the term specificity, and divide it into two separate categories: identification and assay tests.

 

In the case of the assay, demonstration of specificity requires that the procedure is unaffected by the presence of impurities or excipients. In practice, this can be done by spiking the drug substances or product with appropriate levels of impurities or excipients and demonstrating that the assay is unaffected by the presence of these extraneous materials. If the degradation product impurity standards are unavailable, specificity may be demonstrated by comparing the test results of samples containing impurities or degradation products to a second well-characterized procedure.

 

The chromatogram of blank, standard, and test samples was compared to justify the specificity of the target analyte. It has been observed that there were no peaks of diluents and placebo at the main peaks. Specificity studies indicated that the excipients did not interfere with the analysis. There was no interference of excipients in the chromatogram. This indicates that the proposed method is specific.

 

Linearity and Range:29

Linearity is the ability of the method to elicit test results that are directly proportional to analyte concentration within a given range. Linearity is generally reported as the variance of the slope of the regression line. The range is the interval between the upper and lower levels of the analyte that has been demonstrated to be determined with precision, accuracy, and linearity using the method as written. The range is normally expressed in the same units as the test results obtained by the method. The ICH guidelines specify a minimum of five concentration levels and certain minimum specified ranges.

 

Linearity of the proposed UV method was established using seven different calibration standards. Based on the analysis of calibration standards, calibration curves in terms of absorbance vs. concentration plots were developed and subjected to linear least square regression analysis. R square value was considered to be an important factor for establishing the linearity of the proposed method. The interval between the upper and lower concentration limit with acceptable linearity was reported to be the range of the proposed UV method.

 

For the assay, the minimum specified range is from 80-120 % of the target concentration. For an impurity test, the minimum range is from the reporting level of each impurity to 120 % of the specification.

 

Accuracy:30

Accuracy is the measure of exactness of an analytical method or the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. It is measured as the percent of analyte recovered by assay, by spiking samples in a blind study. For the assay of the drug substance, accuracy measurements are obtained by comparison of the results with the analysis of standard reference material or by comparison to a second, well-characterized method. For the assay of the drug product, accuracy is evaluated by analyzing synthetic mixtures spiked with known quantities of components.

 

To document accuracy the ICH guideline on methodology recommends collecting data from a minimum of nine determinations over a minimum of three concentration levels covering the specified range (for example, three concentrations, three replicates each). The data should be reported as the percent recovery of the known, added amount, or as the difference between the mean and true value with confidence intervals. Percent recoveries of the results suggest that the recoveries are well in the acceptance range, consequently, the method was discovered to be correct.

 

Precision:30

Precision is the measure of the degree of repeatability of an analytical method under normal operation and is normally expressed as the percent relative standard deviation for a statistically significant number of samples. According to the ICH, precision should be performed at three different levels: repeatability, intermediate precision, and reproducibility. Repeatability is the result of the method operating over a short time interval under the same conditions of inter-assay precision. It should be determined from a minimum of nine determinations covering the specified range of the procedure, for example, three levels, three repetitions each, or from a minimum of six determinations at 100 % of the test or target concentration. Intermediate precision is the results from within lab variation due to random events such as different days, analysts, equipment, etc. In determining intermediate precision, experimental design should be employed so that the effects of the individual variables can be monitored.

 

Limit of Detection:31

The limit of detection is defined as the lowest concentration of the analyte in the sample that can be detected, though not necessarily quantitated. Limit tests specify whether an analyte is above or below a certain value. LOD may be calculated based on the standard deviation of the response and the slope(S) of the calibration curve at levels approaching the LOD according to the formula: LOD = 3.3 (S.D/A). The standard deviation of the response is determined on basis of the standard deviation of the blank, that is on the residual standard deviation of the regression line. Or it can also be determined by the standard deviation of the y-intercept of the regression lines. It is mandatory to document and support the method used to determine LOD. An appropriate number of samples should be analyzed to validate the developed method.

 

Limit of Quantitation:31

The limit of quantitation (LOQ) is defined as the detection of the lowest amount of analyte present in the sample. It is the parameter that gives the actual concentration of an analyte in a sample which can be determined with acceptable precision and accuracy under the stated operating conditions of the method during analysis. The calculation of LOQ is based on the standard deviation (S.D) of the response and the slope (A) of the calibration curve. The formula to calculate is; LOQ = 10 (S.D/A). The standard deviation of the response is determined based on the standard deviation of the blank (S.D), the residual standard deviation of the regression line, or the standard deviation of y-intercepts of regression lines of the plot. Similar to LOD, the method used to determine LOQ should also be documented and supported. An appropriate number of samples should be analyzed at the limit to validate the method developed.

 

Robustness:31

Robustness is defined as the capacity of a method to remain unaffected by small but deliberate variations in method parameters. The robustness of a method is evaluated via various method parameters which include the percentage of organic solvent, pH, ionic strength, or temperature, and determining the effect on the results of the method. The robustness evaluation should be considered during the development phase and depends on the type of study under study. It should show the reliability of analysis concerning deliberate variations in method parameters. A robustness test was carried out by small variation in the chromatographic conditions at a concentration equal to the standard concentration and a % change in the results was calculated. Here robustness was performed by a change in mobile phase ratio, mobile phase flow rate, and wavelength of the detector.

 

System Suitability Testing:31

System suitability testing isan integralpartofmany analytical procedures. The tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability testparameterstobeestablishedfora particularprocedure depend on the type of procedure being validated. See Pharmacopoeias for additional information.

 

CONCLUSION:

A broad definition of a drug would include - "all chemicals other than food that affect living processes." If the effect helps the body, the drug is said to be a medicine. Further, it can be elaborated as a chemical and medicinal means for treatment, mitigation, or prevention of diseases in human beings or animals for internal or external use. The ever-increasing use of chemotherapeutic and pharmacodynamic agents in pharmaceutical formulation makes their determination a matter of foremost importance. Pharmaceutical chemistry is a science that makes use of the general laws of chemistry to study drugs i.e., their preparation, chemical nature, composition, structure, and influence on an organism and the study of the physical and chemical properties of drugs, the methods of quality control and conditions of their storage.

 

Quality assurance and control of pharmaceutical chemicals and formulations are essential for ensuring the availability of safe and effective drug formulations to consumers. The quality of the drugs encompasses the potency, uniformity, purity, pharmacological action, stability, etc. It is the responsibility of the manufacturer to maintain the quality and produce effective, safe, and non-toxic forms of the drug. Hence pharmaceutical analysis occupies a vital role in the statutory certification of drugs and their formulations either by the industry or by the regulatory authorities. All these salient features of a drug help a researcher not only in planning a precise experimental design but also in the interpretation of data in a scientific manner for the determination of the drug in its pharmaceutical formulations.

 

Visible spectrophotometric techniques have been extensively used in the present investigation. Five drugs have been chosen for the development of new analytical methods with the selection of appropriate chromogenic reagents for their assay by exploiting their characteristics (physical and chemical properties), based on the basic moieties and functional groups present to them.

 

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21.   Hemlata M. Nimje, Rajesh J. Oswal, Sandip S. Kshirsagar, Manoj Chavan. Spectrophotometric Analysis for Estimation of Felodipine in Tablet Dosage Form by Calibration Curve Method. Research J. Pharm. and Tech. 2011; 4(12): 1805-1806.

22.   Kumarswamy Ummiti, J.V. Shanmukha Kumar. Applications of Fourier Transform Infrared and UV-Visible Spectroscopy for the demonstrating sameness of Ganirelix peptide in Liquid Injection Formulation. Research Journal of Pharmacy and Technology. 2022; 15(4): 1709-2.

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25.   Meghana JR, Anitha R, Rajeshkumar S, et al. Characterisation of Cumin oil mediated silver nanoparticles using UV-visible spectrophotometer and TEM. Research Journal of Pharmacy and Technology. 2019; 12(10): 4931-4933.

26.   Santhanabharathi N, Anupama N, Vivek P, et al. In Silico Anti-HIV Analysis of FTIR Identified Bioactive Compounds Present in Vitex altissima L and Vitex leucoxylon L. Research Journal of Pharmacy and Technology. 2019; 12(4): 1773-1782.

27.   Rajashri R. Kulkarni, Dipti G. Phadtare, Ravindra B. Saudagar. UV Spectrophotometric Method Development and Validation of Fluticasone Propionate. Asian J. Res. Pharm. Sci. 2016; 6(2): 135-138.

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30.   Audumbar Mali, Ankush Hake, Manoj Patil, Ritesh Bathe, Ashpak Tamboli. Simultaneous UV Spectrophotometric Methods for Estimation of Paracetamol and Domperidone in Bulk and Tablet Dosage Form. Asian J. Res. Pharm. Sci., 2016; 6(1): 21-26.

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Received on 13.06.2022       Modified on 09.10.2022

Accepted on 06.01.2023   ©Asian Pharma Press All Right Reserved

Asian J. Pharm. Ana. 2023; 13(2):122-130.

DOI: 10.52711/2231-5675.2023.00021