Analytical Perspectives on Clindamycin: Review of Methods in Formulations and Biological Samples

Patil Bhagyashri Sandip, Javesh.K. Patil, Chaudhari Hemangi Somnath, Patil Bhagyashri Sunil

P.S.G.V.P. Mandal’s College of Pharmacy, Shahada.

*Corresponding Author E-mail: bhagyashripatil5853@gmail.com, javesh4u@gmail.com

ABSTRACT:

Strong antibiotics like clindamycin, which belong to the lincosamide class, are frequently used to treat bacterial infections, especially those that involve anaerobes and Gram-positive bacteria. The necessity for accurate, dependable, and effective analytical techniques for clindamycin measurement and quality control has grown as pharmaceutical companies work to comply with regulatory regulations. An extensive examination of the different analytical techniques created for the determination of clindamycin in pharmaceutical dosage forms, bulk medications, and biological matrices is presented in this article.The majority of the article is devoted to chromatographic techniques, particularly high-performance liquid chromatography (HPLC), which is still the most popular approach because of its exceptional resilience, accuracy, and precision.We evaluated several detection methods used in conjunction with HPLC, including UV, and fluorescence, as well as advancements in reversed-phase HPLC (RP-HPLC) for separation optimization. We examine alternative methods in addition to chromatography, such as spectrophotometric and electrochemical procedures, each of which has advantages specific to the matrix and analytical requirements. The selection of the type of column, the detection wavelength, and the mobile phase composition are only a few of the different factors that are addressed in depth while developing a method. The International Council for Harmonization (ICH) and other regulatory requirements are consulted for examining key validation criteria, such as linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ).

KEYWORDS: Analytical Perspectives, Clindamycin, Review.

1. INTRODUCTION:

1.1 Clindamycin:

The antibiotic clindamycin, a lincosamide, was created in 1966 by chemically altering the lincomycin that occurs naturally. Its range of activity in vitro includes the majority of anaerobic bacteria (including more than 90% of Bacteroides fragilis), Chlamydia trachomatis, and certain protozoa. It also includes staphylococci, streptococci, and pneumococci. It is active against most Streptococcus pneumoniae, microaerophilic streptococci, and group A and B streptococci, just as penicillin. Nevertheless, it exhibits no efficacy against enterococci. Clindamycin has anti-Staph aureus properties, similar to cloxacillin and the cephalosporins. Compared to most cephalosporins, it covers a larger anaerobic surface area, but it seldom works against aerobic Gram-negative bacteria. Clindamycin has a role in the treatment of head and neck, respiratory, bone, and soft tissue infections due to its exceptional activity against both Gram-positive cocci and Gram-positive or gram-negative anaerobes.¹

1.2 Common Analytical Techniques:

Analytical analysis of bulk drug materials, intermediates, drug products, drug formulations, contaminants and degradation products, and biological samples containing the pharmaceuticals and their metabolites is crucial in the field of pharmaceutical research. From the commencement of official pharmaceutical analysis, analytical test methods were included in the compendial monographs with the purpose to define the quality of bulk drug materials by setting limits of their active component content. Titrimetry, spectrometry, chromatography, and capillary electrophoresis are some of the test techniques that have been included in monographs in recent years.²

2. Comparative Insights into Analytical Approaches for Clindamycin Analysis:

Clindamycin is a commonly used antibiotic, and reliable techniques for analyzing it are crucial to guaranteeing its efficacy, safety, and quality in all pharmaceutical applications. With an emphasis on both biological matrices and pharmaceutical formulations, a large number of research have investigated and reported several analytical techniques for clindamycin measurement in recent years. We may better understand the advancements and gaps in clindamycin analysis, including the creation of environmentally friendly and extremely sensitive clinical approaches, by compiling the body of available material in an organized manner. For researchers and physicians looking to expand on traditional procedures, find the best approaches for particular applications, and tackle contemporary issues in clindamycin analysis, this compilation is an invaluable resource.

3. Development and Validation of an RP-HPLC Method for Clindamycin Analysis

This table below outlines the chromatographic parameters used for Clindamycin determination, including analytical technique, mobile phase, flow rate and detection wavelength. These conditions are essential for achieving accurate and reliable results in pharmaceutical analysis.

Table 3.1: Chromatographic Conditions for Clindamycin Analysis

Sr.No.	Article Title	Technique Used	Mobile Phase	Flow Rate mL/min	Detection
1.	Determination of Clindamycin in Plasma or Serum by High-Performance Liquid Chromatography with Ultraviolet Detection⁽³⁾	HPLC UV	Acetonitril: water: phosphoric acid:and tetramethylammonium chloride [30:70:0.2:0.075 (v/v)] pH 6.7.	1.0	198nm
2.	Determination of Clindamycin in Human Plasma by High-Performance liquid chromatography using Coupled-Columns⁽⁴⁾	Coupled-column high-performance liquid chromatography (HPLC)	Precolumn-0.015 M monobasic potassium phosphate Analytical Column- a. Acetonitrile–0.028 M dibasic potassium phosphate (1:3, v/v).	0.7	198 nm
3.	Liquid chromatography method for separation of Clindamycin from related substances⁽⁵⁾	HPLC	Acetonitrile–phosphate buffer (1.35% v/v phosphoric acid, pH set to 6.0 using ammonium hydroxide)–water (35:40:25, v/v).	1.0	210
4.	A new HPLC/UV method for the determination of Clindamycin in dog blood serum⁽⁶⁾	HPLC UV	acetonitrile-phosphate buffer (19:81, v/v) with a pH of 3.5- and 2.5-mM tetra-n-butylammonium hydrogen sulfate.	1.0	195
5.	Simple method for the assay of Clindamycin in human plasma by reversedphase high-performance liquid chromatography with UV detector⁽⁷⁾	RP HPLC UV	Acetonitrile: distilled water: 7.6 mM tetramethylammonium chloride (60:40:0.075, v/v/v). Phophoric Acid for pH down to 3.2	1.0	204
6.	Development and Application of a Validated HPLC Method for the Determination of Clindamycin Palmitate Hydrochloride in Marketed Drug Products: An Optimization of the Current USP Methodology for Assay⁽⁸⁾	HPLC using Isocratic reversed phase	pH 3.0, potassium phosphate buffer (5 mM): Tetrahydrofuran: Acetonitrile (20:75:5, v/v/v).	1.0	210
7.	Simple HPLC-UV method for the determination of Clindamycin in human plasma⁽⁹⁾	HPLC UV	Acetonitrile (71:29, v/v) with 0.02 M disodium hydrogen phosphate buffer (pH 2.9).	1.5	195

Table 3.2: Validation Parameters for Clindamycin Analysis

Sr. No.	Article Title	Validation Parameters
Sr. No.	Article Title	Selectivity	Linearity µg/mL	Precision	Accuracy	LOD and LOQ	Stability
1.	Determination of Clindamycin in Plasma or Serum by High-Performance Liquid Chromatography with Ultraviolet Detection	No Interference	0.17 –17.3	Intra day: 2.41% to 4.66% Inter day: 3.32% to 5.71%	within±10	LOD: NS LOQ:0.17	Stable for up to 56 days at -20oC; 10%degradation in 1 year,25-40%in years
2..	Determination of Clindamycin in Human Plasma by High-Performance liquid chromatography using Coupled-Columns	No Interference	0.2-10	Intra Day: 3.4% to 6.7% Inter day: 3.2% to 10.3%	-7.2% and 8.1 %	LOD: NS LOQ:0.2	Remained stable for 6 weeks at 80 oC
3.	Liquid chromatography method for separation of Clindamycin from related substances	No Interference	20-60	NS	NS	LOD: 0.06% LOQ: 0.12%	-
4.	A new HPLC/UV method for the determination of Clindamycin in dog blood serum	No Interference	60- 8000	0.92%- 4.41%	93.98±0.42	LOD: 60ng/ml LOQ: 80ng/ml	Stable in autosampler, during storage and after freeze-thaw cycles.
5.	Simple method for the assay of Clindamycin in human plasma by reversedphase high-performance liquid chromatography with UV detector.	No Interference	0.2 –20	Intra day: 6.0%- 14.5 % Inter day: 6.1%- 14.9%	89.9% - 104.5%	LOD: NS LOQ: 0.2oC	Remained stable for 2 months at 4oC, room temp., and 20 oC
6	Development and Application of a Validated HPLC Method for the Determination of Clindamycin Palmitate Hydrochloride in Marketed Drug Products: An Optimization of the Current USP Methodology for Assay	No iterference	15-500	0.67% to 1.52%	92.0% to 103.8%	-	-
7.	Simple HPLC-UV method for the determination of Clindamycin in human plasma.	No Interference	0.5- 20	-	92.67% - 99.07%	LOD- 01 µg/mL LOQ- 0.2 µg/Ml	Remained stable at -20 oC for 1 and 4 weeks.

This table above displays the validation parameters for single drug methods, including linearity, selectivity, accuracy, and precision. These requirements ensure that the processes are reliable and suitable for routine quality control.

4. CONCLUSION:

This review gathers and appraises earlier published analytical techniques for the quantification of clindamycin in different pharmaceutical and biological matrices. HPLC, more so RP-HPLC, remains the most employed technique for the determination of clindamycin due to its precision, sensitivity, and robustness. Many studies have developed and validated the methods of determination of clindamycin in bulk drugs, formulations, and biological samples, showing good linearity, accuracy, and recovery. Other techniques such as spectrophotometry, gas chromatography, and capillary electrophoresis have also been investigated, which present different advantages depending on the requirements of the analysis.

Although considerable improvement has been made, further scope for optimization of the method still exists. Such methods are desired to be more environment-friendly, economical, and stability-indicating. Comparing the already available methods shows that sensitivity towards trace-level detection and simultaneous estimation of clindamycin along with other pharmaceutical agents needs improvement. Further studies are expected to improve the current methodologies for greater efficiency, reducing the time for analysis, and following the ever-changing regulatory requirements.

This article makes a valuable contribution by systematically summarizing previous work on the development of clindamycin methods, which is useful for research and pharmaceutical analysts in search of reliable analytical approaches to quality control and pharmacokinetic studies.

5. REFERENCES:

1. Smieja, M. Current indications for the use of clindamycin: A critical review. Canadian Journal of Infectious Diseases. 1998; 9(1): 22-28. https://doi.org/10.1155/1998/538090

2. Siddiqui, M. R., AlOthman, Z. A., and Rahman, N. Analytical techniques in pharmaceutical analysis: A review. Arabian Journal of Chemistry. 2017; 10(S1): S1409-S1421. https://doi.org/10.1016/j.arabjc.2013.04.016

3. La Follette, G., Gambertoglio, J., White, J. A., Knuth, D. W., and Lin, E. T. Determination of clindamycin in plasma or serum by high-performance liquid chromatography with ultraviolet detection. Journal of Chromatography. 1988; 431: 379-388.

4. Fieger-Buschges, H., Schußler, G., Larsimont, V., and Blume, H. Determination of clindamycin in human plasma by high-performance liquid chromatography using coupled columns. Journal of Chromatography B. 1999; 724: 281-286.

5. Orwa, J. A., Vandenbempt, K., Depuydt, S., and Roets, E. Determination of clindamycin from related substances. Journal of Pharmaceutical and Biomedical Analysis. 1999; 20(5): 745-752. https://doi.org/10.1016/S0731-7085(99)00044-3

6. Batzias, G. C., Delis, G. A., and Koutsoviti-Papadopoulou, M. A new HPLC/UV method for the determination of clindamycin in dog blood serum. Journal of Pharmaceutical and Biomedical Analysis. 2004; 35(3): 545-554.

7. Cho, S. H., Im, H. T., Park, W. S., Ha, Y. H., Choi, Y. W., and Lee, K. T. Simple method for the assay of clindamycin in human plasma by reversed-phase high-performance liquid chromatography with UV detector. Biomedical Chromatography. 2005; 19(9): 783-787.

8. Wu, G. K., Gupta, A., Khan, M. A., and Faustino, P. J. Development and application of a validated HPLC method for the determination of clindamycin palmitate hydrochloride in marketed drug products: An optimization of the current USP methodology for assay. Journal of Analytical Sciences, Methods and Instrumentation. 2013; 3(4): 202-211.

9. Mifsud, M., Vella, J., Ferrito, V., Serracino-Inglott, A., Azzopardi, L. M., Sammut Bartolo, N., LaFerla, G., and Sammut, C. A simple HPLC-UV method for the determination of clindamycin in human plasma. Journal of Chemical and Pharmaceutical Research. 2014; 6(1): 696-704.

Received on 08.05.2025 Revised on 31.05.2025

Accepted on 17.06.2025 Published on 12.07.2025

Available online from July 21, 2025

Asian Journal of Pharmaceutical Analysis. 2025; 15(3):243-246.

DOI: 10.52711/2231-5675.2025.00038

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.