RP-HPLC Method Development Validation And Degradation Studies For Combined Tablet Dosage-Form Of Saxagliptin & Dapaglifozin

Abstract

A new simple, rapid, economical reverse phase high performance liquid chromatographic method was developed for the determination of Dapagliflozin and Saxagliptin in bulk and dosage-form. The separation was carried out by using column as Hypersil ODS-C18 (250mm×4.6 mm i.d.2.5µm), mobile phase Methanol: Acetonitrile: acetate buffer (pH of4.0)40:40:20 v/v, at a flow rate of 1.0ml/min, diluent as 80:20v/v mixture of water & methanol used. The detection was made by UV-Vis. Spectrophotometer at 228nm. The retention times were 2.314min for Dapagliflozin and 2.904min for Saxagliptin. Calibration curve was linear over the concentration range of 2.04 to 12.05μg/ml for Dapagliflozin and 1.06 to 6.10μg/ml for Saxagliptin, mean recoveries obtained for Dapagliflozin and saxagliptin were 99.89-100.37% and 100.37-100.83% respectively, limit of detection and limit of quantification were found to be 0.257 & 0.780µg/ml and 0.439 & 1.33µg/ml respectively. The propose method was validated as per the ICH guidelines parameters. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug in the combined dosage form.