Stability-indicating HPLC for remogliflozin, vildagliptin, and metformin: Method development, validation, and
Himani Acharya1, Rajendra Kotadiya1
1Department of Pharmaceutical Quality assurance, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), CHARUSAT Campus, Changa, Anand, 388421 Gujarat, India.
Objective:
The present work represents a reverse-phase high-performance liquid chromatography method in addition to stability studies for sequential estimation of remogliflozin etabonate, vildagliptin, and metformin HCl in tablet formulation.
Method:
The mentioned method utilizes a Phenomenex Luna C18 column (250×4.6mm, 5μm). It consists of a column oven's temperature of 35°C. Mobile phase includes a mixture of 50% phosphate buffer (pH - 6.8) and 50% acetonitrile along with a flow rate of 0.8mL/min and 20minutes of run time. The injection volume was 20μL; 217nm is a detection wavelength, and a PDA detector is used for detection.
Results:
The suggested technique was proven and validated per the ICH Q2 (R1) guideline. The combination was put under stress conditions that included acid, base, thermal, photolytic, and oxidative degradation. The combination was considerably degraded under oxidative, acidic, and basic circumstances for deterioration, and the degradation results were accurately identified from the observed peaks, demonstrating the method's effectiveness in detecting stability.
Conclusion:
The technique was quick, precise, sensitive, and accurate; as a result, it may be used in quality control laboratories and the pharmaceutical industry for routine quality monitoring of tablets containing all three medications.
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