A Highly Validated RP-HPLC Method Development and Validation for Simultaneous Estimation of Vildagliptin and Dapagliflozin in Synthetic Mixture

Vildagliptin and Dapagliflozin were quantitatively analysed using a diode array detector-based RP-HPLC technology that is specific, precise, accurate, robust, cost-effective, and reproducible. At ۴۰ °C, the chromatogram was run through an Enable C۱۸ column (۱۵ cm × ۴.۶ mm, ۵ µm) using a mobile phase that contained ۲۰ mM ammonium acetate buffer {۴۰: ۶۰} and acetonitrile: methanol in the ratio (۸۰: ۲۰). At ۲۲۰ nm, the solution was pushed through the column at a rate of ۱ mL/min. The retention times for Dapagliflozin and Vildagliptin were ۸.۵۲۳ and ۲.۴۴۳ minutes, respectively. For Vildagliptin and Dapagliflozin, the calibration plots were created across the concentration ranges of ۱۰-۱۲۵ μg/ml and ۱-۱۲.۵ μg/ml, respectively, with correlation coefficients of ۰.۹۹۹۷ and ۰.۹۹۹۲. According to the ICH standard, the developed technique was verified to conform to all validation parameters. This approach may be successfully used for routine drug analysis in both research laboratories and pharmaceutical companies.

کلیدواژه ها:

Vildagliptin ، Dapagliflozin ، RP-HPLC ، Method Validation ، ICH guideline (Q۲R۱)