Estimation and Evaluation of Mexiletine for Bio-availability and Bio-equivalence studies by Liquid phase extraction using LC-MS/MS

Abstract

The work aims to develop an appropriate method for mexiletine with 35-65% recovery by the LPE method with efficient and selective efficacy of the IS and analyte for the analysis under Liquid Chromatography-Mass Spectrometry/ Mass Spectrometry. This method also reveals the bio-availability and bio-equivalence report for Internal Standard & working standard. At first, the selection of proper IS. The Internal standard should be structurally more similar to mexiletine. The selection of method plays a major role in which extraction procedure is done either by LPE or SPE. The selection of separation procedure should be either isocratic or gradient. Selection of column on bases separation principle of the compound. Since separation is the major principle for chromatography. Argon and Nitrogen Gas is used as carries with a flow-rate of 2L min. Temperature at 20°C, the pressure at 20psi. If the instrument doesn't show any peak or response in after loading sample, check the columns is an aqueous or reverse-phase and then submit the sample. Check all the solution and column and temperature and system stability before loading the sample. After loading the sample, must form calibration curve it must form linearity. The method found should possess the following parameters Specific & Selectivity, Precision & Accuracy. The work aims to develop a simple, elegant way for quantification of a molecule and the method determined will have recovery of 35-65% worldwide. This quantification will be further utilized in Full-Method Validation.