Development and Validation of a Method for Simultaneous Determination of Metformin Hydrochloride and Sitagliptin Phosphate in a Formulation by RP-HPLC

Abstract

A simple, specific, sensitive, precise and accurate reverse phase high performance liquid chroma- tographic method (RP-HPLC) was developed for the simultaneous analysis of Metformin and Sax- agliptin in active pharmaceutical ingredients (APIs) as well as in marketed tablet (combination) dosage forms. The method was achieved on Enable C18 G (250 × 4.6 mm; 5 μm particle size) column using 0.05 M KH2PO4 buffer (pH 4.5):Methanol:Acetonitrile (60:20:20 %v/v) as a mobile phase at a flow rate of 0.6 mL/min and by employing UV detection at 220 nm wavelength. The retention time of Metformin and Saxagliptin were found to be 4.38 min and 6.92 min, respectively. The method was validated as per ICH guidelines. The limit of detection (LOD) and limit of quantification (LOQ) of Metformin were found to be 0.112 µg/mL and 0.373 µg/mL, respectively, while those of Saxag- liptin were found to be 0.029 µg/mL and 0.096 µg/mL, respectively. The method was found to be rapid, sensitive, linear, specific, accurate, precise and economic for the quality control and stabili- ty assays of Metformin and Saxagliptin in marketed tablet dosage forms.