Study of degradation profile by developing validated analytical methods for quantitative estimation of some new drugs in their combined dosage form

Abstract

Antidiabetic drugs have gained significant attention in the pharmaceutical industry, prompting the need for the development and validation of new stability study analytical methods. In this analytical work, the concurrent estimation of multiple antidiabetic drugs along with drug acting on OAB syndrome which include Sitagliptin, Ertugliflozin, Saxagliptin, Dapagliflozin, Remogliflozin, Metformin, Evogliptin, Mirabegron and Solifenacin succinate was undertaken. To achieve this, three analytical methods were employed: RP-HPLC, UHPLC, and HILIC. The RPHPLC method utilized an Agilent Tech. HPLC system with a fortis C18 (100×4.6 newlinemm id) 2.5 µm column particle size. For UHPLC resolution analysis, the Shimadzu SCL-10Avp HPLC system with an Agilent Poroshel 120 EC-C18 (50×3.0 mm id) 2.7 µm column particle size was employed. Lastly, the HILIC method was analyzed using the Shimadzu SCL-10Avp HPLC system with an Acclaimed Mix mode newlineHILIC-1 (150×4.6 mm id) 5 µm column particle size at ambient temperature, employing different solvent systems. Thorough validation of the developed methods newlinewas conducted. This study successfully developed and validated new stability study newlineanalytical methods (RP-HPLC, UHPLC, and HILIC) for the concurrent estimation newlineof multiple antidiabetic drugs. The proposed methods exhibit accuracy, precision, newlinereproducibility, specificity, and stability indicating properties, making them valuable newlinetools for routine quality-control analysis in the pharmaceutical industry focusing on newlineaccuracy, precision, sensitivity, robustness, ruggedness, selectivity, and specificity. newlineThis confirms their suitability for the routine quality-control analysis of these newlineantidiabetic drugs in bulk and combined dosage form. newlineKeywords: HILIC, UHPLC, RP-HPLC, Sitagliptin, Ertugliflozin, Saxagliptin, Dapagliflozin, Remogliflozin, Metformin, Evogliptin, Mirabegron, Solifenacin succinate, Stability-indicating assay.