Abstract
For simultaneous measurement of Dapagliflozin (DAPA) and Saxagliptin (SAXA) in combination, as well as quantification of their major degradation products, a simple reversed-phase high-performance liquid chromatographic technique was devised and validated. The separation was accomplished using an ODS C18 column (250 mm 4.6 mm, i.d.5 m) with isocratic elution at room temperature. The optimum mobile phase consists of an aqueous phase (sodium acetate buffer, pH 4) and an organic phase (acetonitrile: methanol, 40:40) at a ratio of (20:80). The flow rate was set to 1.0 ml min-1, and effluents were measured using a 228 nm diode array detector. This method showed good linearity over a range of 2.0-12 μg ml-1 and 1-6 μg ml-1 for DAPA and SAXA respectively. The retention times of samples were 2.31 and 2.90 minutes for DAPA and SAXA respectively. According to the International Conference Harmonization (ICH) criteria, the drugs in combination were submitted to different stress degradation studies. The suggested approach is appropriate for stability investigations, according to the results of the stress degradation experiments. The proposed method was simple, rapid and precise for the study of a new formulation that has been approved for the cure of diabetes mellitus.
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