LC-MS Based Quantification of Degradents in Pharmaceutical and Bulk Products of Metformin HCl and Remogliflozin Etabonate
Abstract
The present study focuses on the development and validation of a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Metformin HCl (MET) and Remogliflozin Etabonate (REM) in pure form and pharmaceutical dosage forms. The analytical method was meticulously designed to effectively separate and quantify the two drugs in the presence of their degradation products under various stress conditions, ensuring its robustness and reliability for stability testing. A C18 column was employed for the chromatographic separation, using a mobile phase consisting of a mixture of acetonitrile and phosphate buffer (pH adjusted to 3.0) in a gradient mode. The flow rate was maintained at 1.0 mL/min, and detection was carried out at 235 nm. The method demonstrated excellent linearity over the concentration ranges of 25-150 µg/mL for MET and 2.5-15 µg/mL for REM, with correlation coefficients (r2) exceeding 0.990 for both drugs. The forced degradation studies, including acidic, alkaline, oxidative, thermal, and photolytic conditions, revealed that the method could effectively separate the degradation products from the intact drugs, confirming its stability-indicating capability. The degradation behavior of both drugs was studied, and the results indicated significant stability under neutral and oxidative conditions, while notable degradation was observed under acidic, alkaline, and photolytic stress. The method was fully validated according to ICH guidelines, demonstrating satisfactory precision, accuracy, specificity, robustness, and system suitability parameters. The method was found to be precise with an RSD of less than 2% and accurate with recovery rates between 98% and 102% for both drugs. In conclusion, the developed RP-HPLC method is highly efficient, specific, and reliable for the simultaneous estimation of MET and REM in pure and pharmaceutical dosage forms, making it suitable for routine quality control and stability testing in industrial and research settings.
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