A Green Approach: Optimization of the UPLC Method Using DoE Software for Concurrent Quantification of Pioglitazone and Dapagliflozin in a SNEDDS Formulation for the Treatment of Diabetes.

Abstract

Clinical trials revealed that pioglitazone (PGZ) and dapagliflozin (DGZ) not only maintain normal blood glucose levels but also reduce complications of diabetes mellitus. To meet the demand for simultaneous measurement of these drugs in fixed combinations, an optimized and green UPLC method is required. The present study utilized Design of Experiments (DoE) software to optimize analytical parameters for simultaneous drug analysis. The method was validated for its linearity, accuracy, and precision. Furthermore, the drug content was estimated in different pharmaceutical dosage forms. Finally, Analytical Greenness (AGREE) software was utilized to assess the environmental sustainability of the optimized UPLC method. Drugs were successfully separated using optimized conditions on the C18 Acquity BEH column (2.1 mm × 100 mm, 1.7 μm) at a temperature of 45 °C. The mobile phase consisted of ethanol and 9 mM ammonium formate buffer (43.7:56.3), with elution carried out at a flow rate of 0.246 mL/min. The optimized method showed excellent linearity (R ² > 0.999), accuracy (92.45-109.25%), and good precision (RSD < 6.27%) for both drugs. In addition, the optimized UPLC method was able to determine the drug content within the marketed pharmaceutical dosage form accurately. The developed UPLC method also prioritized eco-friendliness by using green solvents to minimize the negative impact on the environment. The green UPLC method provides a reliable and accurate approach to estimate PGZ and DGZ in a fixed diabetes treatment combination. It promotes sustainable lab practices and paves the way for analytical methods for new dose combinations.