Abstract

The present study reports on a liquid chromatography-tandem mass spectroscopy method for the analysis of gemfibrozil drug substance in its formulation. Isocratic separation was achieved using Zorbax SB C18 column (4.6×50 mm, 3µm) analytical column with electrospray ionization and a triple quadrupole mass detector in multiple reaction monitoring (MRM) mode, resulting in a short analysis of 3 min runtime and the analyte elute at 1.201min. (10mM) ammonium formate adjusted to pH 3.5: methanol (20:80 V/V) was used as mobile phase. Change from SIM to MRM mode resulted in increased sensitivity and low quantitation limit which in turn produces a detection limit of 0.5ng/ml. The obtained method was validated in a range of 1-50 ng/ml with a correlation coefficient of 0.999. The percentage recovery of the present method was found to be in the range of 94.03 to 100.02 %. The developed method was validated as per the ICH guidelines.

Key words: Gemfibrozil, LC-MS/MS, Electrospray Ionization, Validation