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Volume: 9, Issue: 5, May, 2019
DOI: 10.7324/JAPS.2019.90512



Research Article

A novel analytical liquid chromatography-tandem mass spectrometry method for the estimation of Gemfibrozil in bulk and pharmaceutical formulations

S. Vishnupriya, S. T. Narenderan, K. Vishnu, B. Babu, S. N. Meyyanathan

  Author Affiliations


Abstract

The current study reports on a mass spectrometric method for the quantification of gemfibrozil drug substance in its formulation. Isocratic method was used for separation with help of Zorbax SB C18 column (4.6 × 50 mm, 3 μm) using a triple quadrupole mass detector in multiple reaction monitoring (MRM) mode and electrospray ionization as ionization source. The resulting runtime was found to be 3 minutes and the analyte elutes at 1.201 minutes 10-mM ammonium formate was adjusted to pH 3.5: methanol (20:80 V/V) was used as mobile phase. Increased sensitivity from selective ion 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 recovery was found to be in the range of 94.03 % to 100.02 %. The developed method was validated as per the International Conference on Harmonisation (ICH) guidelines.

Keywords:

Gemfibrozil, LC-MS/MS, electrospray ionization, validation.



Citation: Vishnupriya S, Narenderan ST, Vishnu K, Babu B, Meyyanathan SN. A novel analytical liquid chromatography-tandem mass spectrometry method for the estimation of Gemfibrozil in bulk and pharmaceutical formulations. J Appl Pharm Sci, 2019; 9(05):097–101.


Copyright: The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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