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Sci. Pharm. 2014, 82(3), 571-584; doi:10.3797/scipharm.1402-19

Development and Validation of a Liquid Chromatography-Mass Spectrometry Method for the Determination of Zileuton in Human Plasma

1
Nirmala College of Pharmacy, Mangalagiri, Guntur 522503, AP, India
2
Department of Biotechnology, Acharya Nagarjuna University, Guntur, AP, India
*
Author to whom correspondence should be addressed.
Received: 27 February 2014 / Accepted: 26 April 2014 / Published: 26 April 2014
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Abstract

A selective and sensitive liquid chromatography-tandem mass spectrometric method (LC-MS/MS) has been developed and validated for the quantification of zileuton in human plasma. Deuterated internal standard (zileuton D4) was used as the internal standard (ISTD). Zileuton was extracted by liquid-liquid extraction using methyl tert-butyl ether and separated by isocratic elution on a C18 column (100 x 4.6 mm, 5 μm, Discovery C18) with the mobile phase consisting of 1 mM ammonium acetate buffer and methanol in the ratio of 10:90. A flow rate of 1.0 ml/min was used with isocratic elution. Multiple reaction monitoring transitions in positive mode for zileuton and the internal standard were 237.3/161.2 and 241.2/161.1, respectively. The method was validated within the linearity range of 50.5–10,012.7 ng/ml for the bioanalytical method validation parameters like selectivity, accuracy, precision, recovery, stability, and matrix effect.
Keywords: Zileuton; Plasma; LC-MS/MS; Validation Zileuton; Plasma; LC-MS/MS; Validation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

PRAKASH, K.; ADIKI, S.K.; KALAKUNTLA, R.R. Development and Validation of a Liquid Chromatography-Mass Spectrometry Method for the Determination of Zileuton in Human Plasma. Sci. Pharm. 2014, 82, 571-584.

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