Method development and validation for the simultaneous estimation of saxagliptin and metformin in tablet dosage form by RP-HPLC method

Abstract

A RP-HPLC method was developed and validated for the simultaneous estimation of MetforminHydrochloride (MET) and
Saxaagliptin (SGL) in pure and pharmaceutical dosage form. Chromatography was carried on PhenominexC18(250 mm × 4.6
mm, 5 μm) column with mobile phase comprising of phosphate buffer and acetonitrile in the ratio( 60:40) v/v. The flow rate
was adjusted to 0.7 ml/min with UV detection at 242 nm. The retention times of MET and SGL were found to be 1.7 min, 2.9
min respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, limit of detection
(LOD), limit of quantification (LOQ) were determined according to the ICH-Q2B guidelines. The detector response was
linear in the range of 100-600μg/ml, 1-6 μg/ml for MET, SGL respectively. The proposed RP-HPLCmethod is sensitive,
precise and accurate so it was successfully applied for the reliable quantification of drugs in the commercial dosage form.