alexa Method Development and Validation for the Determination
ISSN: 1948-593X

Journal of Bioanalysis & Biomedicine
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Research Article

Method Development and Validation for the Determination of Pravastatin in Human Plasma by Lc-Ms/Ms

Lian Chen*, Paresh Joshi, Andrii Piatkivskyi, Kalem Aguilar and Jenny Lin

CMIC, Inc. 2860 Forbs Avenue, Hoffman Estates, IL 60192, USA

*Corresponding Author:
Lian Chen
CMIC, Inc. 2860 Forbs Avenue, Hoffman Estates
IL 60192, USA
Tel: 847-645-0407
Fax: 847-645-0412
E-mail: [email protected]

Received date: May 22, 2017; Accepted date: June 08, 2017; Published date: June 16, 2017

Citation: Chen L, Joshi P, Piatkivskyi A, Aguilar K, Lin J (2017) Method Development and Validation for the Determination of Pravastatin in Human Plasma by Lc-Ms/Ms. J Bioanal Biomed 9:137-143. doi: 10.4172/1948-593X.1000168

Copyright: © 2017 Chen L, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

A simple, rapid, sensitive and selective liquid chromatography/tandem mass spectrometry (LC/MS/MS) method was developed and validated for the quantification of pravastatin in human plasma. Pravastatin-D3 was used as an internal standard. The analyte was extracted from human plasma samples by liquid-liquid extraction technique. Due to the presence of isobaric metabolites, 3α-iso-pravastatin and 6-epi-pravastatin, chromatographic conditions were optimized, with a C18 column by using a mixture of 0.1% acetic acid in water and acetonitrile/methanol (43:57, v/v) as the mobile phase at a flow rate of 0.6 mL/min. The calibration curve obtained was linear (r2 ≥ 0.9900) over the concentration range of 0.500-500 ng/mL. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. The method was suitable for supporting clinical studies.

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