Abstract

DEVELOPMENT, OPTIMIZATION AND VALIDATION OF AN RP-HPLC METHOD FOR ESTIMATION OF IMEGLIMIN HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMS

Popalayat V. B., Shinde R. N.*, Dr. Ingole R. D., Amle S. D., Jadhav N. D., Ture P. R., A. A. Parodwad

ABSTRACT

Imeglimin Hydrochloride is a novel oral antidiabetic drug belonging to the glimin class and is widely used in the management of Type 2 Diabetes Mellitus. The increasing therapeutic importance of this drug necessitates the development of a reliable, accurate, and economical analytical method for its routine quality control. The present study aimed to develop and validate a simple, rapid, precise, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative estimation of Imeglimin Hydrochloride in bulk drug and pharmaceutical tablet dosage forms. Chromatographic separation was achieved on a Hypersil BDS-C18 column using an optimized mobile phase consisting of Methanol:Water Acid under isocratic conditions. The analysis was performed at a detection wavelength of 242 nm, which provided a sharp, symmetrical, and well-resolved chromatographic peak with satisfactory retention time and excellent system suitability characteristics. The developed method was validated in accordance with ICH Q2(R1) guidelines by evaluating linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), limit of quantification (LOQ), assay, and solution stability. The calibration curve exhibited excellent linearity over the selected concentration range with a correlation coefficient (R² > 0.999). Accuracy studies demonstrated satisfactory percentage recovery within the acceptable range, while repeatability and intermediate precision showed %RSD values below 2%, confirming the reproducibility of the method. Robustness studies revealed that minor deliberate variations in chromatographic parameters did not significantly affect the analytical performance. Stability studies confirmed that the prepared sample solutions remained stable for 24 hours, ensuring reliable routine analysis. The developed method was successfully applied to the assay of marketed tablet formulations, producing satisfactory drug content with no interference from formulation excipients. The proposed RP-HPLC method is simple, sensitive, accurate, economical, and less time-consuming, making it highly suitable for routine quality control, stability studies, pharmaceutical industries, research laboratories, and academic institutions. The validated method can serve as an effective analytical tool for the regular estimation of Imeglimin Hydrochloride in bulk drug and tablet dosage forms.Imeglimin Hydrochloride, RP-HPLC, Method Development, Method Validation, ICH Q2 (R1), Quality Control, Pharmaceutical Analysis, Type 2 Diabetes Mellitus.

Keywords: Imeglimin Hydrochloride, RP-HPLC, Method Development, Method Validation, ICH Q2 (R1), Quality Control, Pharmaceutical Analysis, Type 2 Diabetes Mellitus.