HPLC-MS/MS METHOD FOR SIMULTANEOUS QUANTIFICATION OF VILDAGLIPTIN, METFORMIN, AND METFORMIN-RELATED COMPOUNDS IN TABLETS
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2014, Vol 6, Issue 11
Abstract
Objective: The present study developed and validated a high-performance liquid chromatography-tandem mass spectrometry method for simultaneous determination of vildagliptin, metformin, and metformin-related compounds (A, B, and C) in tablets.Methods: Chromatographic separations were achieved on a C8 column (150 × 4.6 mm, 5 µm particle size) maintained at 25°C. The isocratic mobile phase consisted of acetonitrile/water/formic acid (20:80:0.1, v/v/v), eluted at 800 μL/min. The volume of injection was 20 μL and the electrospray source was operated in positive ion mode.Results: Data from validation studies demonstrated that the new method was highly selective, sensitive (limits of detection ≤ 0.6 ng/mL), precise (RSD < 5%), and accurate (RE < 5%). All of the calibration curves showed excellent coefficients of correlation (r ³ 0.99) over the ranges of 5‑150 ng/mL for vildagliptin, 250‑2000 ng/mL for metformin, and 2.5‑25 ng/mL for metformin-related compounds A, B, and C. Quantification of these compounds in tablets showed that they contained from 95.2‑101.2% (vildagliptin) and 97‑104.4% (metformin) of the stated level. No metformin-related compounds were detected using this highly sensitive method.Conclusion: This new method is presented as an alternative approach to the quality control of tablets containing vildagliptin, metformin, and metformin-related compounds.Â
Authors and Affiliations
Caroline Paola Uber, FlÃvia Lada Degaut Pontes, JoÃo Cleverson Gasparetto, Thais Martins GuimarÃes De Francisco, MÃrio SÉrgio Piantavini, Marco AndrÉ Cardoso, Roberto Pontarolo
Keywords
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