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.
OP-D03
Bioanalytical
Method Development and Validation for Quantitation of Metformin and Glipizide
in Human Plasma
Suman
Shrivastava and SJ Daharwal
University
Institute of Pharmacy, Pr. Ravishankar Shukla University, Raipur
Corresponding
author email: sumanshrivastava1991@gmail.com
[Received
4 January 2016; 13 January 2016]
Abstract:
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.
Keywords:
Metformin, Sitagliptin, Glipizide