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

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