Development And Validation of a Simple, LCMS Compatible New Assay Method for The Simultaneous Estimation of Anti-Diabetic Drugs Metformin, Sitagliptin and Glimepiride

A simple, rapid, precise, accurate and reproducible RP- HPLC method was developed for the simultaneous estimation of Metformin, Glimepiride and Sitagliptin in tablet dosage forms. The developed method was validated with different parameters such as linearity, precision, accuracy and solution stability as per ICH guidelines. It was further applied to simultaneous quantitative estimation of Metformin, Glimepiride and Sitagliptin in tablet dosage forms. The method was developed using Hemochrom C8 column (250mm x 4.6mm, 5µm) using Acetonitrile and Trifluoroacetic acid combination as a mobile phase in gradient mode with PDA detector. The detection wavelength was set at 210 nm for Metformin and Sitagliptin and 228 nm Glimepiride quantification respectively. The retention times of Sitagliptin, Metformin and Glimepiride were found to be around 14 min, 4.8 min and 18.5 min. The assay of the developed method was found to be within 98-102% for all the three APIs in the formulations. The % RSD for reproducibility was found to be ˂ 2.0% Conclusion: The proposed method was statistically evaluated by validation and can be applied for routine quality control analysis of Sitagliptin, Metformin and Glimepiride in bulk and in the tablet dosage form.