UV METHOD DEVELOPMENT FOR ALOGLIPTIN & PIOGLITAZONE USING HYDROTROPIC PHENOMENON
Vikky Dawar, Ankit Diwan, Kuldeep Ganju
ABSTRACT
Alogliptin (AGT) and Pioglitazone (PGZ) are widely used in combination therapy for the management of type 2 diabetes mellitus. Developing a simple and economical analytical method for their simultaneous estimation is essential for quality control of pharmaceutical formulations. The present work aimed to develop and validate a UV spectrophotometric method for the simultaneous estimation of AGT and PGZ using the hydrotropic phenomenon, following ICH guidelines. A UV method was developed employing hydrotropic solubilization to enhance the aqueous solubility of AGT and PGZ. The method was validated for linearity, accuracy, precision, repeatability, and reproducibility. Linearity was evaluated in the concentration range of 5–25 µg/ml for both drugs. Accuracy was determined through recovery studies at three levels (80%, 100%, 120%). Precision was assessed by intra-day, inter-day, and analyst-to-analyst variation studies. The validated method was applied for assay of marketed combined tablet formulation. The developed method showed excellent linearity with correlation coefficients of 0.9997 for AGT and 0.9998 for PGZ. %Recovery ranged from 98.24–98.85% (AGT) and 97.64–98.51% (PGZ), confirming method accuracy. Precision studies yielded %RSD values below 2%, indicating good reproducibility. The assay results for marketed tablets were 99.40% (AGT) and 99.17% (PGZ) of label claim, meeting pharmacopeial requirements. The developed UV spectrophotometric method using hydrotropic phenomenon is simple, accurate, precise, and cost-effective. It can be successfully applied for routine quality control analysis of Alogliptin and Pioglitazone in bulk and pharmaceutical dosage forms, offering a greener and economical alternative to chromatographic methods.
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