Simultaneous Estimation of Pioglitazone, Glimepiride & Metformin Hydrochloride in Bulk and Tablet Dosage Form by FTIR and LC-MS
Abstract
Abstract Background: Combination therapy involving pioglitazone, glimepiride, and metformin hydrochloride is widely prescribed for the management of type 2 diabetes mellitus due to their complementary mechanisms of action. Accurate and simultaneous estimation of these drugs in bulk and combined dosage forms is essential to ensure quality, safety, and therapeutic efficacy. However, analytical challenges arise from differences in physicochemical properties and the concentration ranges of these drugs.
Objective:: The present study aims to develop and validate simple, rapid, and reliable Fourier Transform Infrared (FTIR) spectroscopic and Liquid Chromatography–Mass Spectrometry (LC-MS) methods for the simultaneous estimation of pioglitazone, glimepiride, and metformin hydrochloride in bulk and tablet dosage forms.
Methods:: FTIR analysis was performed using characteristic absorption peaks with suitable calibration models, while LC-MS analysis employed optimized chromatographic conditions with appropriate mobile phase composition and mass detection parameters. Method validation was carried out in accordance with ICH guidelines, evaluating parameters such as linearity, accuracy, precision, specificity, limit of detection (LOD), and limit of quantification (LOQ).
Results:: Both FTIR and LC-MS methods demonstrated excellent linearity within the selected concentration ranges, with correlation coefficients (R²) exceeding 0.998. Accuracy studies showed satisfactory recovery (98–102%),…
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