Development of a Dissolution Method for Dapagliflozin Propanediol Monohydrate and Metformin Hydrochloride Tablets

The purpose of this study was to develop and validate a method for dissolving film-coated tablets containing 5 mg dapagliflozin propanediol monohydrate (DAPA) and 850 mg metformin hydrochloride (MET). Four different types of dissolution media, two agitation speeds, and Apparatus 2 (paddle) were used. Analysis of the tablets was performed using HPLC at 223 nm for DAPA and 270 nm for MET. The ideal parameters included the use of an acetate buffer (0.05 M) at pH 4.5, an agitation speed of 50 rotations per minute (rpm), and a volume of 500 ml. The developed dissolution method has been validated according to USP46. In the validation studies, the method demonstrated specificity by showing no interference from other components, linearity within the range of 1.0 to 10.0 µg/ml with a correlation coefficient (r) of 0.9994 for DAPA and 0.17 to 1.70 mg/ml for MET with a correlation coefficient (r) of 0.9995. The precision, with Relative Standard Deviation (RSD %) values below 2%, was acceptable for both substances. The accuracy was confirmed by percent recovery values of 98.77%, 101.38%, and 104.57% for DAPA and 105.89%, 94.65%, and 98.37% for MET. The effect of the used filters on the concentrations of DAPA and MET was also evaluated, and the stability of the materials in the used dissolution medium was studied, with results that were acceptable. From the findings, it can be deduced that the established technique offers a viable option for conducting dissolution tests for DAPA and MET film-coated tablets in quality control laboratories.