Development and Validation of a Stability-Indicating RP-HPLC Method for Antidiabetic Drugs

Antidiabetic drugs are extensively used for the management of diabetes mellitus, a chronic metabolic disorder characterized by persistent hyperglycemia resulting from defects in insulin secretion, insulin action, or both. Accurate analytical methods are essential to ensure the quality, safety, and efficacy of these drugs during formulation development and throughout their shelf life. The present study focuses on the development and validation of a stability-indicating reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of selected antidiabetic drugs in pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column with an optimized mobile phase consisting of acetonitrile and phosphate buffer under isocratic conditions. Detection was performed using a UV detector at an optimized wavelength suitable for the selected drug molecules. The developed method was validated according to International Conference on Harmonisation (ICH) guidelines for parameters including linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), limit of quantification (LOQ), and system suitability. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions were conducted to establish the stability-indicating capability of the method. The results demonstrated excellent linearity within the studied concentration range with high correlation coefficients. Recovery values confirmed the accuracy of the method, while low relative standard deviation values indicated high precision. The degradation studies revealed that the method effectively separated degradation products from the parent drug peaks. The validated RP-HPLC method was found to be simple, reliable, reproducible, and suitable for routine quality control analysis of antidiabetic drugs in pharmaceutical formulations and stability studies

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