ABSTRACT

To determine mexiletine reliability and also reproducibility. To choose proper IS & analyte. And collect literature review. Then dvelop method and to quantify the method. Mass spectrometry parameters, fragmentation pattern, and mode of ionization are the main task in mass spectrometry tuning to obtain respective fragmented ions and response for both MX and MXD6. ESI-LC-MS/MS is a very powerful technique for pharmacokinetic studies since it provides sensitivity and selectivity requirements for analytical methods. MRM technique was chosen for the assay development. The MRM parameters were optimized to maximize the response for the analyte. The pre method validation is done with six PA batches, out of which three are non-PA batches (except LLOQQC). Along with the PA batches a recovery was performed. The recovery is determined with neat standards and expressed as a percentage. These PA batches are followed with matrix effects and matrix factor. This matrix effect was determined by injecting 6 different lots of blank plasma which are infused with neat standards. Therefore, full-method validation that include 24 parameters performed for the method development for mexilitine within acceptance criteria. Keywords: Mexiletine, Anti-arrhythmic agent, Liquid chromatography-Mass Spectrometry/ Mass Spectrometry, Liquid phase extraction (LPE)
Publication date: 01/06/2022

https://ijbpas.com/pdf/2022/June/MS_IJBPAS_2022_6166.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.6.6166