ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENELIGLIPTIN AND DAPAGLIFLOZIN API IN MARKETED FORMULATION

A simple, novel, precise, rapid, accurate, specific reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate API in marketed formulation was developed and validated. The separation was carried out on a Prontosil C18 (250 x 4.6 mm, 5 m) column using an acetonitrile: 3.5 pH Potassium dihydrogen phosphate buffer (60:40 v/v) mobile phase. The flow rate was 1 mL/min, and the UV detector was set to detect at 227 nm. Teneligliptin Hydrobromide Hydrate retained 2.37 min, while Dapagliflozin Propanediol Monohydrate retained 3.61 min. Teneligliptin hydrobromide hydrate revealed a linear response in the concentration range of 10-30ppm. In the concentration range of 5-15ppm, dapagliflozin propanediol monohydrate demonstrated a linear response. Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate had correlation coefficients (‘R²‘ value) of 0.999 and 0.992, respectively. Various validation parameters were used to validate the analysis results. Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate percentage recoveries vary from 98% to 101%. Both precision and robustness study found to have % RSD values of less than 2. Thus, the suggested method may be successfully used in routine analysis for the method development and validation of Teneligliptin Hydrobromide Hydrate and dapagliflozin propanediol monohydrate.