INTRODUCTION:

Imeglimin is a recently developed therapeutic agent being evaluated for the management of Non insulin dependent diabetis mellitus and represents the primary compound of the newly identified “glimin” category of antihyperglycemic agent. Improvements in insulin secretion and sensitivity are necessary for glycaemic management. which is central to the clinical rationale behind imeglimin therapy.¹

This drug exhibits a distinctive mechanism of action by influencing three major metabolic disturbances associated with Type 2 diabetes is characterized by reduced muscle tissues glucose absorption, elevated hepatic glucose production, and increased beta-cell stress that results in apoptosis. In the second stage and third stages of research, intact imeglimin has shown promising benefits by significantly lowering blood sugar and glucose in fasting plasma value to a meaningful extent. These benefits were seen not only when the drug was used alone but also when it was combined with other commonly prescribed antidiabetic medications.² Imeglimin hydrochloride is a novel oral antihyperglycemic agent that acts through a unique mechanism targeting multiple defects associated with type 2 diabetes mellitus³ The drug was designed with the intention of addressing the key metabolic disturbances seen in people with type 2 diabetes, while still being safe and well tolerated for long-term use.⁴ Type 2 diabetes continues to affect millions of individuals across the world, and its prevalence keeps rising as lifestyles change with rapid urbanisation and shifting socioeconomic conditions. Because of this growing burden, there remains an urgent need for newer and more effective treatment options, and imeglimin is considered one of the promising candidates in this direction.⁵

Mechanism of Action:

This treatment enhances the body's ability to utilize insulin efficiently by decreasing the hepatic production of glucose and optimizing insulin signaling within muscle cells and the liver. Additionally, this strategy boosts the body's ability to produce more insulin after eating sugary foods by improving how well cells respond to sugar signals. It also safeguards the important beta cells of the pancreas, crucial for making insulin necessary for normal blood sugar levels.^6,7

Physical and Chemical Properties⁸

Table 1: Physicochemical Properties of Imeglimin HCl

Parameter	Description
Chemical Name	(6R) -(+)-4-dimethylamino-2-imino-6-methyl-1,2,5,6-tetrahydro-1,2,5-triazine hydrochloride
Molecular Formula	C₆H₁₄ClN₅
Molecular Weight	191.66g/mol
Physical Appearance	White crystalline powder
Melting Point	223–225°C
pKa Value	10.21
Solubility	Soluble in water, methanol, ethanol, Dimethyl Sulfoxide. Particularly soluble in ethyl acetate

Chemical Structure:

Fig no 1 - Imeglimin HCL

Pharmacokinetics:

Imeglimin is an oral antidiabetic medication with a unique pharmacokinetic profile: it is absorbed in the gut through both passive paracellular pathways and an active, saturable transporter mechanism that results in dose-dependent absorption; it reaches peak plasma levels usually around 1.5–3.5hours after oral dosing it undergoes minimal metabolism, with the unchanged parent drug being the predominant circulating entity it is primarily excreted in the urine through active renal secretion involving organic cation and multidrug extrusion transporters its elimination half-life is typically between 9–20hours. Its pharmacokinetics are not significantly impacted by food intake.⁹

Pharmacodynamics:

Imeglimin enhances beta cell function and promotes glucagon-like peptide-1-driven insulin secretion among individuals suffering from type 2 diabetes. Moreover, this intervention enhances blood sugar management while reducing glucose concentrations through heightened insulin responsiveness. insulin-producing beta cell quantity within individuals suffering from Type II diabetes through its effects on pancreas functionality over extended periods of use. By utilizing an innovative system, this drug enhances the production of insulin in response to high blood sugar levels by stimulating pancreatic beta cells¹⁰.

Analytical Method Development:

Based on ICH Q2(R1) for method validation, ensuring documentation confirms reliable production of desired results adhering to specified standards through rigorous testing demonstrates confidence in achieving consistent outcomes. this method demonstrates its efficacy in validating analytical techniques as applicable to their designated purposes thereby substantiating the authenticity, consistency, cleanliness, and strength of medicinal materials and formulations. Verification of procedures becomes crucial whenever novel methodologies emerge and are employed across various laboratories by distinct operators. To substantiate methodology through evaluation criteria.^11,12.

Method Validation:

It is an essential process in analytical chemistry that ensures a method's correctness and reliability. These recommendations place a strong emphasis on aspects like method robustness, which evaluates the technique's capacity to function consistently under minute changes in experimental settings, and system appropriateness, which evaluates whether the system is functioning properly before beginning an analysis.¹³

Parameters of Method Validation:

1. Accuracy

2. Precision

3. Linearity

4. Specificity

5. Range

6. Limit of Detection (LOD)

7. Limit of Quantification (LOQ)

8. Robustness

9. Ruggedness¹⁴

Accuracy:

Accuracy may be defined as the degree of closeness between the experimental outcomes generated through this technique and their actual values. The accuracy of an analytical technique can be quantified as a measure.¹⁵

Precision:

Precision measures the analytical method's repeatability under normal working conditions.¹⁶

Linearity:

The term "linearity" describes how well an analytical technique converts test outcomes directly into measurable concentrations based on sample levels falling within specified limits.¹⁷

Specificity:

Specificity is the ability of a method to identify particular analytes in a complex mixture without interference from other mixture components.¹⁸

Range:

The range of the analytical procedure is the interval between the greatest and lowest analyte concentration in the sample for which the analytical technique has been demonstrated to have an appropriate degree of precision, accuracy, and linearity.¹⁹

Limit of detection:

The limit of detection (LOD) of an analytical method is the lowest concentration of an analyte in a sample that is detectable but not directly quantifiable.²⁰

Limit of quantification:

The limit of quantitation is the lowest analyte concentration in a sample that, under typical circumstances, can be detected with appropriate accuracy and precision using the given method.²¹

Robustness:

Robustness is the ability of an analytical technique to tolerate small but deliberate changes in method parameters, demonstrating the method's dependability under normal operating conditions. ²²

Ruggedness:

An analytical method's ruggedness is the degree of repeatability of test results achieved by analysing the same samples under multiple typical test conditions, such as different laboratories and different analysts.²³

Chromatographic Techniques:

UV Visible spectroscopy:

The use of qualitative analysis is to determine the identity of an analyte, while quantitative analysis provides a numerical measurement of the concentration or amount of that analyte.²⁴ Analytical Chemistry is compasses both traditional wet chemical approaches and modern instrumentation as means of analysis. In UV/Vis spectroscopy, atoms and molecules absorb UV and Vis light (200 – 400nm), which excites their electrons from lower energy states to higher energy states. The energy levels within matter are quantized; therefore, only light with sufficient energy will cause these transitions in an atom/molecule. UV/Vis spectrophotometric instruments utilize mathematical calculations to process and produce absorbance spectra from both standard and sample solutions using absorbance and additivity rules.²⁵

High Performance Liquid Chromatography:

HPLC stands for high-performance liquid chromatography it's an important technique within column chromatography utilized extensively in biochemical research and analysis for separating, identifying, and quantifying various compounds.²⁶comprises three key elements A packed column housing the stationary substance an injector moving liquid substances along this path and a monitor displaying molecule retention periods. The analysis time for substances is influenced by factors such as the type of support material used in chromatography, the specific compounds under examination, and the liquid employed during separation processes.²⁷

Ultra High-Performance Liquid Chromatography:

It improves over three areas compared to standard High Performance Liquid Chromatography systems Increase Sensitivity of Analysis, Increase Speed of Analysis, and Increase Chromatographic Resolution. Ultra High Performance Liquid Chromatography utilizes smaller diameter particles, results in using a reduced amount of solvent, and takes less time. However, the packings that are utilized by High Performance Liquid Chromatography for the separation have changed, as well. provide separations via packing material is that, by lowering the particle scale of the packing material in the column, one can increase efficiency and thus the chromatographic resolution from the column. According to the conventional Van Deemter equation, increasing linear velocity or flow rate do not decrease the efficiency of the system but instead cause a dramatic increase in system efficiency when the column packing material particle size is decreased below 2.5µm ²⁸.

Reverse Phase High Performance Liquid Chromatography:

The widely adopted technique is used primarily within biology, chemistry, pharmacy, and medicine fields to isolate valuable components from complex mixtures prior to analysis.This method utilizes a nonpolar hydrophilic matrix containing an octanol bonded to silica particles serving as the stationary component, alongside water-based eluents for analysis purposes. Given that many drugs and medications have an electric charge characteristic, their solubility is higher due to quicker release compared to those which remain stable over extended durations this occurs at timescales ranging between approximately twenty-nine and thirty days^29,30. The liquid component consists of water mixed with an organic substance alternatively, it could use columns filled with materials like C18 or C8 as its support material. These setups serve primarily when analyzing substances such as those dissolved in organic-water solutions due to their ability to handle both polar and uncharged molecules effectively.³¹

High Performance Thin layer Chromatography:

It provides far better separation, increased automation, and better repeatability of results when compared to traditional Thin layer chromatography Methods Chromatography and it has been effectively used in a number of industries, including food and beverage, pharmaceutical, and environmental analysis, to identify and quantify a wide range of complex mixtures.³²

Reported Method for Imeglimin Hydrochloride:

Imeglimin Hydrochloride is a widely used antidiabetic agent it act on mitochondria and shows two effect insulin secretion and insulin sensitivity. Creating a trustworthy analytical procedure is critical ensuring it's efficacy, safety and quality in Pharmaceutical application. Over the years, researchers have been investigating different methods of analytical procedure for the quantification of Imeglimin Hydrochloride using different analysis types including biological matrices and pharmaceutical formulation. Some of these methods include UV spectrophotometry, RP-HPLC (Reverse Phase High Performance Liquid Chromatography) which have revolutionised Imeglimin Hydrochloride analysis.

In 2024, Rahul Godge and colleagues developed and validated reverse phase high performance liquid chromatography method for quantitating Imeglimin from tablets. The RP-HPLC (Reverse Phase High Performance Liquid Chromatography) method described here has the ability to provide high sensitivity and accuracy, and precision. used an Agilent C18 column (250mm × 4.6mm, 5µm) as the stationary phase the mobile phase is made from a solution of methanol and 0.1% orthophosphoric acid (40:60) to separate Imeglimin from the other components in the tablet. a flow rate of 0.7mL/min, and was detected by using a UV detector in absorbance of 240nm. The retention time of Imeglimin is 4.718min, which indicates good separation for quantitation purposes. Calibration curves for Imeglimin have been generated between 10 and 50 µg/mL.³³

Table 2: RP-HPLC Conditions by Rahul Godge et al.

Parameters	Description
Column Name	Agilent C18 (250mm × 4.6mm, 5µm)
Mobile Phase	Methanol and 0.1% Orthophosphoric acid (40:60 v/v)
Flow Rate	0.7 ml/min
Detection Wavelength	240 nm
Retention Time	4.718 minute

V. S. Holey and his co- workers published this research work in the year 2024 with the objective of developing and validating a stability-indicating RP-HPLC (Reverse Phase High Performance Chromatography) method for the estimation of Imeglimin Hydrochloride.The separation was performed with a Hypersil BDS C18 column at a flow rate of 1.0ml/min using methanol: buffer (70:30 v/v) and detected at 239nm with a retention time of 3.47min. The method demonstrated exceptional linearity (R² > 0.999) and has been validated according to ICH Q2(R1) for accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantitation (LOQ). The results of the stability studies indicated that the compound degraded under acidic, basic, and oxidative conditions, demonstrating the stability-indicating nature of the method.³⁴

Table 3: RP-HPLC Conditions by V. S. Holey et al.

Parameters	Description
Column Name	Hypersil BDS C18 (250mm × 4.6mm, 5µm)
Mobile Phase	Methanol and Buffer (70:30 % v/v)
Flow Rate	1.0ml/min
Detection Wavelength	239nm
Retention Time	3.47minute

In order to develop and validate an RP-HPLC (Reverse Phase High Performance Chromatography) method for determination of Imeglimin Hydrochloride in bulk drug and tablet dosage form, Navali and his co- workers published their research work in the year 2024. A chromatographic separation with a BRISA LC C18 column (25cm × 4.6mm, 5µm) was performed using an isocratic mobile phase, 10mM phosphate buffer (pH 6) and methanol, under a flow rate of 1.0mL/min. Detection was performed at 243nm, and the retention time for Imeglimin Hydrochloride was 3.907min. The method demonstrated a good degree of linearity over a concentration range of 10-21µg/mL, with R² ≈ 1, and also demonstrated an accuracy in the range of 100.23–100.83%. The precision of the method was ≤ 2% RSD, and the method was validated in accordance with the ICH Q2 (R1) Guidelines as accurate, precise, robust, and suitable for routine use.³⁵

Table 4: RP-HPLC Conditions by Navali et al.

Parameters	Description
Column Name	BRISA LC C18 (25cm × 4.6mm, 5µm)
Mobile Phase	Methanol and Phosphate buffer (10mM, pH 6.0)
Flow Rate	1.0mL/min
Detection	243nm
Retention Time	3.907minute
Linearity Range	10–21µg/ml
Accuracy	100.23–100.83%.

Chikhale and his colleagues published this research work in the year 2024 with the objective of developing and validating an RP-HPLC (Reverse Phase High Performance Chromatography) method for the determination of antidiabetic drug Imeglimin Hydrochloride in bulk drug and pharmaceutical dosage form. A Phenomenex C18 column used A methanol and 0.05% trifluoroacetic acid (TFAA) in water (20:80 v/v) as mobile phase was employed at a flow rate of 1.0 mL/min and detection at a wavelength of 240nm. This chromatographic method resulted in symmetric and sharp peaks with good resolution. Additionally, this method exhibited linearity over a concentration range of 1.0 to 15.0µg/mL. The validation of this method according to the International Conference on Harmonization (ICH) guidelines. The average recovery percentage was 99.36% indicating that this method is highly accurate.³⁶

Table 5: RP-HPLC Conditions by Chikhale et al.

Parameters	Description
Column Name	Phenomenex C18 (250 × 4.6mm, 5µm)
Mobile Phase	Methanol and 0.05% TFAA in water (20:80 v/v)
Flow Rate	1.0mL/min
Detection	240nm
Linearity Range	1.0–15µg/ml
Mean Recovery	99.36%

In the year 2023, the study was published by Ajay Salvi and his co- workers for the development and validation of an RP-HPLC (Reverse Phase High Performance Chromatography) method for estimation of antidiabetic drug Imeglimin Hydrochloride in bulk and tablet dosage form. Separation was completed using a Hypersil ODS C18 column (150mm x 4.6mm, 5µm). For the mobile phase, buffer (pH 3.0) was mixed with methanol (75:25 v/v) and this mixture was pumped through the column at a flow rate of 1.0mL/min. The detector worked at a wavelength of 234nm. Retention time was determined to be 6.30minutes. Linearity was determined in the concentrations of 100–300µg/mL, as indicated by the correlation coefficient r² = 0.9999. Accuracy was calculated at the mean recovery (100.5%), and precision (%RSD<0.5) was calculated from the precision study results. Specificity, robustness and fit for routine quality control analysis have all been demonstrated.³⁷

Table 6: RP-HPLC Conditions by Ajay Salvi et al.

Parameters	Description
Column Name	Hypersil ODS C18 (150mm × 4.6mm, 5µm)
Mobile Phase	Buffer (pH 3.0) and Methanol (75:25 v/v)
Flow Rate	1.0mL/min
Detection	234nm
Retention Time	6.30minute
Linearity Range	100–300µg/ml
Accuracy	100.5%

The study was published by Vachala and his colleagues in the year of 2023 for the development and validation of a UV/Visible spectrophotometric method for estimation of Imeglimin Hydrochloride. The approach uses an absorbance measurement in the UV-Vis spectrum (200-400nm) with 0.1N sodium hydroxide as the dilution solvent. The wave number of the peak maximum absorbance (λmax) was determined to be 245nm, and the method exhibited a linear response over 2-12µg/mL. Recovery averaged 100.91%, suggesting accurate results; while reproducibility was demonstrated through precision assessments. Thus, the developed methodology has been validated for Imeglimin Hydrochloride and proved to be accurate, precise, sensitive, easy to execute, and low-cost, making it appropriate for everyday analysis to ensure quality control.³⁸

Table 7: UV Method by Vachala et al.

Parameters	Description
Method	UV/Visible Spectrophotometry
Solvent	0.1 N NaOH
Wavelength (λmax)	245 nm
Linearity Range	2–12 µg/ml
Accuracy	100.91%
LOD	6.920 µg/ml
LOQ	4.846 µg/ml

In the year 2023, the study was published by Avnish and his co-workers for the development and validation of a stability-indicating RP-UHPLC (Reverse Phase Ultra High-Performance Liquid Chromatography) method for estimation of Imeglimin Hydrochloride. The chromatographic separation employed a Hypersil Gold ODS column using a mobile phase of water and acetonitrile (15:85 v/v ratio) at a flow rate of 1.0 mL/min. Detection occurred at a wavelength of 240nm with the retention time of Imeglimin Hydrochloride measured at 3.831min. The method displayed high linearity, with an equation of the line being y = (3199 x) +1605.5, and a coefficient of determination of R squared (R²) greater than 0.999. The validation parameters, including those for specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantitation (LOQ), were within acceptable limits according to ICH guidelines.³⁹

Table 8: RP-UHPLC Conditions by Avnish et al.

Parameters	Description
Column Name	Hypersil Gold ODS (150 × 4.6mm, 3µm)
Mobile Phase	Water and Acetonitrile (15:85 v/v)
Flow Rate	1.0ml/min
Detection	240nm
Retention Time	3.831minute

CONCLUSION:

This review collects and evaluates previously published methods used to measure Imeglimin Hydrochloride in various pharmaceutical and biological samples. RP-HPLC (Reverse Phase High Performance Liquid Chromatography) Its widely used for determining Imeglimin Hydrochloride because of its accuracy, precision, and reliability. Numerous studies have created and confirmed methods for estimating Imeglimin Hydrochloride in raw materials and finished products. Other approaches, such as high-performance liquid chromatography and UV Spectroscopy have also been explored. This study contributes significantly by organizing and summarizing existing research on the development of methods for analyzing Imeglimin Hydrochloride. It functions as a significant source of information for researchers and pharmaceutical professionals seeking reliable analytical techniques for quality control and drug metabolism studies.

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Received on 26.03.2026 Revised on 09.05.2026

Accepted on 12.06.2026 Published on 10.07.2026

Available online from July 25, 2026

Asian Journal of Pharmaceutical Analysis. 2026; 16(3):204-209.

DOI: 10.52711/2231-5675.2026.00031

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