Analytical Method Development and Validation of Stability Indicating RP-HPLC Method For Imeglimin Hydrochloride

ABSTRACT

The present study describes the development and subsequent validation of Reverse phase HPLC (RP-HPLC) method for the analysis of Imeglimin hydrochloride. A novel economic, simple, rapid, accurate, reproducible, and precise Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for Imeglimin hydrochloride. The method was performed on a YOUNG LIN-HPLC system-ACME9000. The method developed for Imeglimin hydrochloride was quantitatively measured using an isocratic RP-HPLC methodology. The chromatographic separation of Imeglimin hydrochloride was achieved on RP-HPLC equipped with Hypersil BDS C18 (250mm x 4.6mm, 5 um) column using isocratic elution with a mobile phase consisting of MeOH: Buffer in a ratio of (70:30% v/v) at a flow rate of 1.0ml/min with an injection volume of 20µl, where detection was carried out by UV- 730D detector at 239nm The retention time for Imeglimin hydrochloride was found to be 3.47 min. The developed method was successfully with results falling within acceptable criteria validated for different validation parameters as per (ICH-Q2 (R1)) guidelines. The linear regression equation was found to be y = 27.83x - 8.512 with a correlation coefficient (R2) > 0.999 which shows excellent linear correlation. Accuracy, precision, specificity, system suitability, robustness, linearity, LOD and LOQ were determined for method validation. The results were found to be well within recommended limits as per ICH guidelines. Stability studies of Imeglimin hydrochloride were carried out under acidic, basic, peroxide, photolytic and thermal conditions. Degradation was observed in acidic, basic, and oxidative conditions, but not in photolytic and thermal conditions.  

Keywords: Imeglimin hydrochloride, RP-HPLC, Development, Validation, Stability studies, Type 2 diabetes (T2D).