"Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Saxagliptin and Sitagliptin in Bulk and Pharmaceutical Dosage Forms"

Abstract

An accurate and precise method was developed for the simultaneous estimation of Saxagliptin and Sitagliptin in bulk dosage form. The chromatographic analysis was carried out using a Discovery C18 column (4.6 x 150 mm, 5 µm). The mobile phase consisted of acetonitrile and 0.01N KH2PO4 in a 65:35 ratio, with a flow rate of 1.0 ml/min through the column. The buffer used was OPA with a pH of 4.4, and the temperature was maintained at 30°C. The wavelength optimized for detection was 210 nm. The retention times for Saxagliptin and Sitagliptin were determined to be 2.216 minutes and 2.650 minutes, respectively. The %RSD for Saxagliptin and Sitagliptin were found to be 0.5 and 1.1, respectively. The %recovery for Saxagliptin was 99.61%, and for Sitagliptin, it was 100.20%. The LOD and LOQ values, derived from the regression equations, were 0.10 and 0.31 for Saxagliptin, and 1.69 and 5.13 for Sitagliptin. The regression equation for Saxagliptin was y = 12784x + 1088.7, and for Sitagliptin, it was y = 12398x + 11053. The reduced retention times and run time make this method simple and cost- effective, suitable for routine quality control testing in industrial settings.{1}