Abstract

Praveen Khanduri¹and Archana Gahtori^2*

This study developed a UV-spectrophotometric method for the simultaneous quantification of Metformin HCl and Teneligliptin HBr. Both active pharmaceutical ingredients were found to be soluble in 0.1N sulfuric acid, which was thus chosen as the solvent for analysis. The maximum absorption wavelengths for Metformin HCl and Teneligliptin HBr were identified at 220 nm and 240 nm, respectively. Standard stock solutions were prepared, and samples from commercially available tablets were accurately measured and dissolved for testing. Method validation included evaluations of linearity, precision (intra-day and inter-day), accuracy, robustness, as well as detection (LOD) and quantification limits (LOQ). The method exhibited strong precision and accuracy, with %RSD values less than 2%. Both LOD and LOQ demonstrated sufficient sensitivity, and the method proved effective for analyzing commercial formulations, achieving compliance levels of 99.20% for Metformin and 102.00% for Teneligliptin.

ICH Q2 R1 Validation; Metformin HCl; Teneligliptin HBr; Ultraviolet (UV) spectroscopy method

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