A new validated RP-HPLC-photo diode array (PDA) method for the simultaneous estimation of dapagliflozin and saxagliptin in bulk form and pharmaceutical tablet dosage form

Abstract

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Dapagliflozin and Saxagliptinin bulk and pharmaceutical formulations. Separation of Dapagliflozin and Saxagliptin was successfully achieve dona Phenomenex Luna C18 (4.6×250mm, 5µm) particle size or equivalentin an isocratic mode utilizing Acetonitrile: Phosphate Buffer (pH-4.6) (45:55 v/v) at a flow rate of 1.0mL/min an delutes was monitored at 245nm, with are tention time of 2.102 and 3.537 minutes for Dapagliflozin and Saxagliptin respectively. The method was validated and the response was found to be linear in the drug concentration range of 6µg/mL to 14µg/mL for Dapagliflozin and 18µg/mL to 42µg/mL for Saxagliptin. The values of the slope and the correlation coefficient were found to be 77824 and 0.999 for Dapagliflozin and 10515 and0.999 for Saxagliptin respectively. The LOD and LOQ for Dapagliflozin were found to be 0.6µg/mL and1.8µg/mL respectively. The LOD and LOQ for Saxagliptin were found to be 0.8µg/mL and 2.4µg/mL respectively. This method was found to be good percentage recovery for Dapagliflozin and Saxagliptin were found to be 100.351 and 100.93 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analytes in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.