Method Development and Validation of Pravastatin Sodium in Human Plasma by Using LCMS/MS
Kumud Sampath, Ramesh N*, Suresh Kumar, Sasi jith SL and James D Terish
Bioanalytical Department, SeQuent Research Limited, 120 A & B Industrial Area, Baikampady, New Mangalore-575011, India
- *Corresponding Author:
- Dr. Ramesh N
SeQuent Research Limited
120 A & B Industrial Area, Baikampady
New Mangalore-575011, India
Fax: + 91 8242402256
E-mail: [email protected]
Received Date: March 02, 2011; Accepted Date: April 13, 2011; Published Date: April 15, 2011
Citation: Sampath K, Ramesh N, Kumar S, Sasijith SL, Terish JD (2011) Method Development and Validation of Pravastatin Sodium in Human Plasma by Using LCMS/MS. J Bioequiv Availab 3: 048-051. doi: 10.4172/jbb.1000057
Copyright: © 2011 Sampath K, 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.
An Ultra Flow liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for estimation of pravastatin in human plasma. Pravastatin and omperazole (internal standard) were extracted from human plasma using a solid phase extraction procedure with Strata X cartridges. Samples were chromatographed on Hypurity Advance C18, 50 x 4.6 mm, 5μm column using a mobile phase consisting of (80:20, v/v), acetonitrile and 2 mm ammonium formate. Pravastatin and the internal standard were ionised using the electro spray interface operating in negative ion mode. The characteristic ion dissociation transitions m/z 423.1→321.2 and m/z 344→193.8 was monitored for pravastatin and internal standard respectively. The limit of quantitation was 5.078 ng/mL using 250 μl of plasma. Inter and intra batch precision expressed by relative standard deviation was less than 9%. The assay was robust, sensitive, and highly specific and there was no interference from human plasma observed. With a total run-time of 2 minutes, the method was suitable for supporting clinical studies and applied to the analysis of samples from a bioequivalence study.