生物学的同等性とバイオアベイラビリティのジャーナル

概要

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

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.