Selective, sensitive, and rapid liquid chromatography – tandem mass spectrometry method for determination of Glimepiride in human plasma

Abstract

An analytical method based on liquid chromatography–tandem mass spectrometry (LC-MS-MS) was developed and validated for the determination of glimepiride in human plasma. Glimepiride and glimepiride-d4 (internal standard) were extracted from the plasma by solid phase extraction and chromatographed on a C18 analytical column using an isocratic mobile phase. Detection was carried out by positive electrospray ionization (ESI⁺) in multiple reaction monitoring (MRM) mode. The chromatographic separation was obtained within 2 min. Linearity was established from 1.00–500.00 ng/mL with a coefficient of determination (r²) of 0.9981 or greater. The lower limit of quantitation (LOQ) was identifiable and reproducible at 1.00 ng/mL with a precision of 3.8%. The method has shown remarkable reproducibility, with intra- and inter-day precision and accuracy <11.3% and <11.0%, respectively. The method was successfully applied for the quantitation of glimepiride in human plasma to support clinical and pharmacokinetic studies.

Keywords::

• Glimepiride
• LC-MS-MS
• quantitation

Acknowledgments

The authors wish to acknowledge the support and facilities received from Ranbaxy Research Laboratories, Gurgaon, India for carrying out this work.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.