Method development of metformin, saxagliptin and dapagliflozin in marketed formulation by HPLC

The fixed-dose combination of Metformin, Saxagliptin and Dapagliflozin is a recently approved antidiabetic medication. The aim of this study was to develop a simple, rapid, sensitive, and validated isocratic reversed phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Metformin, Saxagliptin and Dapagliflozin in bulk and formulation as per ICH Guidelines. The developed method was found simple, sensitive and economical for the simultaneous estimation of MET, SXG and DGF in their tablet formulation.  The validity and reliability of proposed methods were assessed by recovery studies. The recovery of added standards (80%, 100% and 120%) was found at three replicate and three concentrations level. The value of % means just close to 100, SD and % RSD are less than 2 indicate the accuracy of method.  Precision was determined by repeatability and Intermediate precision of drug. Repeatability result indicates the precision under the same operating condition over short interval time. The intermediate precision study is expressed within laboratory variation on different days and analyst-to-analyst variation by different analyst. The value of SD and %RSD are less than 2 indicate the precision of method.  The robustness of developed method was checked by changing in the deliberate variation in solvent