A RAPID AND SENSITIVE METHOD FOR THE QUANTITATION OF MONTELUKAST IN HUMAN PLASMA USING LIQUID CHROMATOGRAPHY/TANDEM MASS SPECTROMETRYAbstract
A simple, precise and reproducible liquid chromatography–tandem mass spectrometry method has been developed and validated according to the United States – Food and Drug Administration (US-FDA) guidelines for the quantitation of Montelukat in human plasma using Neverapine as an internal standard. Montelukast is a fast acting and potent cysteinyl leukotriene receptor antagonist which is being used in the treatment of asthma. Quantitation was performed on a triple quadrupole mass spectrometer employing electrospray ionization technique, operating in multiple reaction monitoring and positive ion mode. The chromatographic run time was 3.2 mins on a Agilent Zorbax SB C8, 150×4.6 mm, 5.0µm Column. The mobile phase was a mixture of Methanol: 0.1 % Formic acid in water (90:10 v/v). Inter-batch and intra-batch coefficient of variation across four validation runs for the quality control samples was less than 6.02%. The accuracy determined at quality control levels was within 90.98 – 111.07%.
S. Gunasakaran *, Nageshwara Rao, S. Arunkumar and A. Olaganathan
Azidus Laboratories Limited, Chennai, Tamil Nadu, India
05 June, 2010
21 August, 2010
13 September, 2010
01 October, 2010