Analytical Method Development and Validation for the Ipragliflozine and Saxagliptin by using RP-HPLC in Pharmaceutical Dosage Forms as per ICH guidelines

Abstract

This research works the advancement & verification of a RP-HPLC technique for the concurrent quantification of Ipragliflozine & Saxagliptin in formulations. The optimal chromatographic conditions were established using an INTERSIL C18-EP column with a MP of ACN & potassium phosphate buffer (pH 5) in a 70:30 ratio, a flow of 1 ml per min, & detection at 254 nm. The method was systematically verified for various parameters, including assay, linearity, precision, intermediate precision, accuracy, LOD, (LOQ, & robustness. The results demonstrated a strong correlation coefficient for linearity, with acceptable precision and accuracy across different concentrations. The LOD and LOQ for Ipragliflozine were determined to be 0.022 µg per ml and 0.076 µg per ml, respectively, while for Saxagliptin, they were 0.020 µg per ml and 0.075 µg per ml. Robustness testing confirmed method reliability under varied conditions, including flow speed & MP composition. Overall, the advancement HPLC technique is efficient, reproducible, and suitable for regular analysis of Ipragliflozine & Saxagliptin in QC laboratories, ensuring accurate dosage determination in preparations.