Nirav R.Soni,
A-One Pharmacy College, India
Title: Bioanalytical method development and validation of metaxalone in human plasma by LC-MS/MS
Biography
Biography: Nirav R.Soni,
Abstract
Abstract:-A simple, rapid, sensitive, and selective liquid chromatography-tandem mass spectrometry (MS) method was developed and validated for the quantification of Metaxalone, a skeletal muscle relaxant, in human plasma using Metaxalone –D6 as Internal Standard (IS). Following Liquid-Liquid Extraction (LLE) , the analytes were separated using an isocratic mobile phase on a reverse phase C18 column (Chromatopak peerless basic 50× 4.6mm× 3.0µm ) and analyzed by MS in the multiple reaction monitoring mode using the respective [M+H]+ ions, m/z 222.14 / 160.98 for Metaxalone and m/z 228.25 /167.02 for the IS. The assay exhibited a linear dynamic range of 25.19 - 2521.313 ng/mL for metaxalone in human plasma. The goodness of fit was consistently greater than 0.98 during the course of validation. The range of accuracy and precision of the back-calculated concentrations of the standard curve points was from 94.1 % to 104.4 % and 0.3 % to 5.6 % for metaxalone A run time of 2.0 min for each sample and injection volume is 5 µl. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability and bioequivalence (BA-BE) studies.