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Asian Journal of Pharmaceutical Analysis
Year : 2019, Volume : 9, Issue : 4
First page : ( 210) Last page : ( 214)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2019.00035.8

Development and Validation of HPLC Method for the Estimation of Metaxalone in Spiked Human Plasma

Gangurde Prachi, Sonawane Sandeep*, Kshirsagar Sanjay, Chhajed Santosh

Department of Pharmaceutical Analysis, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik, 422003

*Corresponding Author E-mail: sandeeps.iop@gmail.com

Online published on 31 December, 2019.

Abstract

A simple, rapid, accurate, precise and specific HPLC method was developed for the estimation of metaxalone (MAT) in spiked human plasma using darunavir (DAR) as an internal standard (IS). The drug and IS were successfully separated on BDS-C18 column using acetonitrile: water (50: 50%, v/v) as mobile phase in an isocratic mode at a flow rate of 1 mL/min. The MAT and DAR were extracted from the plasma by liquid-liquid extraction using ter-butyl methyl ether (TBME). Eluents were detected at 217 nm. The calibration curve was linear in the range of 0.1–4.0μg/mL. Weighted linear regression was applied with a weighting factor of 1/x to avoid heteroscedasticity. The method was validated for accuracy, precision, recovery, stability and for carry over as per US-FDA guidance for bioanalytical method validation, May 2018.

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Keywords

Metaxalone, human plasma, HPLC, bioanalytical method validation.

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