Optimization of green LC-MS method for rosuvastatin and teneligliptin using AQbD chemometric approach

Abstract

Background: Rosuvastatin combined with Teneligliptin formulation is commonly used in the treatment of Diabetic dyslipidaemia. However, only a few analytical methods have been published for the examination of this drug in a synthetic mixture or in a pharmaceutical dosage form. This study demonstrates the successful application of AQbD principles in developing a reliable, efficient, and environmentally friendly LC-MS method. Methodology: Box-Behnken Model: Design of experiment (DoE) strategy to identify and optimize critical method parameters using systematic risk assessment. Methanol: 10mM potassium dihydrogen orthophosphate [pH:6.0] (35:65v/v) was the mobile phase employed in the final optimized LC method, and this was using a Waters LC Xbridge C18 Column 5µm (4.6x250mm) as the stationary phase. The experiment was conducted at a flow rate of 1 mL/min, with a 10 µL injection volume, and an ESI-MS-QDA Detector for detection. An analytical method for validation was applied in accordance with ICH Q2 (R1) guidelines. Results and Discussion: The retention times of Rosuvastatin and Teneligliptin were observed at 4.392 and 3.202 minutes, respectively. The optimized technique showed excellent linearity, accuracy, precision, and robustness. Additionally, AGREE metrics and AES were used for assessing the eco-friendly nature of the developed method. Conclusion: The combination of green principles with AQbD experimental design ensures the robustness of the method. This combined framework is used for the first time in method development for the analysis of rosuvastatin with teneligliptin in formulations. Based on the above facts, an economical, robust, and time-saving method has been developed for assessing the quality control of rosuvastatin with teneligliptin in both pharmaceutical and pure forms.