A novel analytical liquid chromatography-tandem mass spectrometry method for the estimation of Gemfibrozil in bulk and pharmaceutical formulations
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Date
2019-05
Authors
S., Vishnupriya
S.T, Narenderan
K., Vishnu
B., Babu
S.N, Meyyanathan
Journal Title
Journal ISSN
Volume Title
Publisher
Open Science Publishers LLP
Abstract
The current study reports on a mass spectrometric method for the quantification of gemfibrozil drug substance in itsformulation. Isocratic method was used for separation with help of Zorbax SB C18 column (4.6 × 50 mm, 3 µm) using atriple quadrupole mass detector in multiple reaction monitoring (MRM) mode and electrospray ionization as ionizationsource. The resulting runtime was found to be 3 minutes and the analyte elutes at 1.201 minutes 10-mM ammoniumformate was adjusted to pH 3.5: methanol (20:80 V/V) was used as mobile phase. Increased sensitivity from selectiveion monitoring (SIM) to MRM resulted in decreased quantitation limit (LOQ) and 0.5 ng/ml as detection limit (LOD).The method was validated in a range of 1–50 ng/ml and a correlation coefficient of 0.999. The method recoverywas found to be in the range of 94.03 % to 100.02 %. The developed method was validated as per the InternationalConference on Harmonisation (ICH) guidelines
Description
Keywords
Gemfibrozil, LC-MS/MS, electrospray ionization, validation.
Citation
S. Vishnupriya, S.T Narenderan, K. Vishnu, B. Babu, S.N Meyyanathan. A novel analytical liquid chromatography-tandem mass spectrometry method for the estimation of Gemfibrozil in bulk and pharmaceutical formulations. Journal of Applied Pharmaceutical Science. 2019 May; 2019 May: 097-101