RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND SAXAGLIFLOZIN IN BOTH BULK AND PHARMACEUTICAL FORMULATION

U. Mohan Kumar, S. Lakshmi Naga Aparna, G. Tejaswi, K. Vijay Kumar, Narahari Narayan Palei, I. Theja*

A novel, reliable, and reproducible RP-HPLC method has been successfully developed and validated for the simultaneous quantification of Metformin and Saxagliptin in bulk drug and pharmaceutical dosage forms. Separation was achieved on a Thermo C18 column (250 × 4.6 mm, 5 µm) under isocratic conditions, employing a mobile phase of 0.1 M KH₂PO₄ and methanol (65:35, v/v) at a flow rate of 1.0 mL/min. Detection at 256 nm yielded sharp peaks with retention times of 2.737 min for Metformin and 3.384 min for Saxagliptin. The method demonstrated excellent linearity over the concentration range of 50–150 µg/mL for both drugs, with correlation coefficients of 0.999 and 1.000, respectively. Sensitivity studies revealed LOD/LOQ values of 0.747/2.488 µg/mL for Metformin and 0.0268/0.0893 µg/mL for Saxagliptin. Accuracy was confirmed through recovery studies, with mean recoveries of 100% for both analytes. Specificity testing showed no interference from formulation excipients, underscoring the reliability of the method. Validation in line with ICH guidelines for linearity, accuracy, precision, specificity, and robustness confirms the method’s suitability for routine quality control of Metformin and Saxagliptin in bulk and tablet dosage forms.