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%20%20%20%20Sensitive%20and%20Rapid%20Determination%20of%20Gliclazide%20in%20Human%20Plasma%20by%20UPLC-MS/MS%20and%20its%20Application%20to%20a%20Bioequivalence%20Study
Research article
  

Sensitive and Rapid Determination of Gliclazide in Human Plasma by UPLC-MS/MS and its Application to a Bioequivalence Study


Darshan V. Chaudhary, Daxesh P. Patel, Jaivik V. Shah, Mallika Sanyal, Puran Singhal, Pranav S. Shrivastav

1Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad- 380009, India.
2Department of Chemistry, St. Xavier’s College, Navrangpura, Ahmedabad- 380009, India
3Bioanalytical Department, Alkem Laboratories Ltd., Lower Parel, Mumbai-400013


Corresponding author :

Pranav S. Shrivastav,
Tel.: +91-9925471963,
Email:

Received: September 27, 2014,   Accepted: October 28, 2014,   Published:


Abstract:

An ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the determination of gliclazide in human plasma using gliclazide-d4 as the internal standard (IS). The plasma samples were prepared by protein precipitation with acetonitrile employing 50 µL human plasma. Chromatography was performed on Acquity UPLC BEH C18 (50 mm × 2.1 mm, 1.7 µm) analytical column under isocratic conditions using a mobile phase which consisted of 0.1% formic acid in water-acetonitrile (10:90, v/v). The MRM transitions for gliclazide (m/z 324.2 → 127.3) and gliclazide-d4 (m/z 328.2 → 127.4) were monitored on a triple quadrupole mass spectrometer, operating in the positive ionization mode. The method was validated over a dynamic concentration range of 1.0-2000 ng/mL for gliclazide. Matrix effect was assessed by post-column analyte infusion and the mean extraction recovery was 95.7 % across six quality control levels. Stability of gliclazide in plasma was evaluated under different conditions like bench top, auto sampler, dry and wet extract, freeze-thaw and long term stability. The method was applied to a bioequivalence study with 30 mg gliclazide tablet formulation in 28 healthy subjects under fasting. Further, the assay reproducibility was confirmed by reanalysis of 129 incurred samples.


Keywords: UPLC-MS/MS; protein precipitation; sensitive; bioequivalence study


Citation:

Pranav S. Shrivastav, et al (2014), Sensitive and Rapid Determination of Gliclazide in Human Plasma by UPLC-MS/MS and its Application to a Bioequivalence Study. J. of Modern Drug Discovery and Drug Delivery Research. V2I1.DOI: 10.15297/JMDDR.V2I1.03


Copyright:

© 2014 Pranav S. Shrivastav. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


      
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      Journal of Modern Drug Discovery and Drug Delivery Research