ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF IMEGLIMIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

Imeglimin Hydrochloride is a novel anti-diabetic drug used in the management of Type 2 Diabetes Mellitus. The present study focuses on the development and validation of a simple, precise, accurate, and economical Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the determination of Imeglimin Hydrochloride in bulk drug and pharmaceutical dosage form. The chromatographic separation was achieved using a suitable C18 column with an optimized mobile phase consisting of appropriate solvent systems under isocratic conditions. Detection was carried out using a UV detector at a selected wavelength for obtaining optimum sensitivity and peak resolution. The eveloped analytical method was validated according to International Council for Harmonisation (ICH) guidelines for various validation parameters including linearity, accuracy, precision, robustness, limit of detection (LOD), limit of quantification (LOQ), and system suitability. The developed RP-HPLC method demonstrated excellent linearity over the selected concentration range with acceptable correlation coefficient values. Accuracy studies showed satisfactory percentage recovery, while precision studies indicated low %RSD values, confirming reproducibility of the method. The robustness study demonstrated that minor variations in chromatographic conditions did not significantly affect the analytical performance. The developed and validated RP-HPLC method was found to be simple, rapid, sensitive, accurate, and reliable for routine quantitative estimation of Imeglimin Hydrochloride in bulk drug and pharmaceutical dosage forms. Therefore, the proposed method can be successfully applied for quality control analysis in pharmaceutical industries and research laboratories.