A sensitive high performance liquid chromatography positive ion atmospheric pressure tandem mass spectrometry method was developed and validated for the simultaneous determination of metformin and glipizide in human plasma. Following protein precipitation using acetonitrile, the analyte was separated using an isocratic mobile phase 20mM ammonium acetate, adjust pH 4.5 ± 0.2 with formic acid and acetonitrile (50:50 v/v) on a Biobasic SCX column and liquid liquid extraction method was used for glipizide using 10mM Ammonium acetate, adjust pH 3.5 z 0.2 with formic acid and acetonitrile (40:60 v/v) on a Zorbax SB C 8 column. Sitagliptin was used as internal standard for metformin while Glipizide DI1 played the same role for glipizide. It was analyzed by MS/MS Acquity API 4000. The method produces linear responses from 11.556 ng/ml to 2515.659 ng/ml for metformin and 566.144 ng/ml to 249622.500 ng/ml for glipizide respectively. Acceptable precision and accuracy were obtained for concentration over the standard curve range. A simple, rapid, and reliable LCMS/MS method has been established for glipizide and metformin in human plasma. The method has several advantages, including rapid analysis, a simple mobile phase, simple sample preparation, and improved sensitivity. It is suitable for analysis of these antidiabetic agents, in contrast with previous method. This makes the method suitable for routine analysis in quality-control laboratories.
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Cite this article:
Shrivastava and Daharwal (2016). Bioanalytical Method Development and Validation for Quantitation of Metformin and Glipizide in Human Plasma. Journal of Ravishankar University (Part-B: Science), 29(1), pp.85-86.