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Asian Journal of Pharmaceutical Analysis
ISSN: 2231-5675(Online), 2231-5667(Print)
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Development and Validation of HPLC Method for the Estimation of Metaxalone in Spiked Human Plasma
Prachi Gangurde, Sandeep Sonawane*, Sanjay Kshirsagar, Santosh Chhajed
Department of Pharmaceutical Analysis, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 422003
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 0.1-4.0?g/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.
Metaxalone, human plasma, HPLC, bioanalytical method validation.
Prachi Gangurde, Sandeep Sonawane, Sanjay Kshirsagar, Santosh Chhajed. Development and Validation of HPLC Method for the Estimation of Metaxalone in Spiked Human Plasma. Asian J. Pharm. Ana. 2019; 9(4):210-214.
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