DEVELOPMENT AND VALIDATION OF A REVERSE PHASE HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GEMIGLIPTIN AND ROSUVASTATIN IN TABLET FORMULATIONS
A new, rapid, and reliable Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for the simultaneous estimation of Gemigliptin and Rosuvastatin in tablet formulations. The method uses a mobile phase consisting of 0.1% OPA buffer and acetonitrile in a 80:20 v/v ratio, and an Inertsil ODS column (150 x 4.6 mm, 5 µm) at a flow rate of 1.0 mL/min. The wavelength selected for detection was 274 nm based on the UV spectra of both drugs. The method was optimized for precision, linearity, accuracy, robustness, and system suitability, with the validation parameters meeting acceptance criteria. The linearity of the method was established for Gemigliptin in the range of 50-250 µg/mL and Rosuvastatin in the range of 25-125 µg/mL, with correlation coefficients of 0.999. The precision of the method was demonstrated with a % RSD of less than 2.0%. The accuracy was confirmed by recovery studies, which showed recoveries between 99.36% and 100.82% for Gemigliptin and between 99.55% and 100.75% for Rosuvastatin. The limit of detection (LOD) and limit of quantification (LOQ) for both drugs were within acceptable limits, confirming the method’s sensitivity. The method also demonstrated robustness under different conditions, such as changes in flow rate and mobile phase composition. This method is suitable for routine quality control, bioequivalence studies, and dissolution testing of Gemigliptin and Rosuvastatin in tablet formulations.
15 , 1 , 2025
1 - 7
Subscriber Login
