Development and Validation of Analytical Methods for Pravastatin

Three simple, sensitive, accurate, precise, reliable and economical methods have been developed for the quantitative estimation of Pravastatin in bulk and in its pharmaceutical formulation. Method-1 was an HPLC method and the chromatographic separation was carried out on column of Hypersil ODS,3μm,10cm×4.6mm. The mobile phase comprised of acetonitrile, methanol and 0.08M ortho phosphoric acid in the ratio of 23:20:57 v/v/v. The pH of the mobile phase was adjusted to 2.8 by TEA (Tri Ethyl Amine), pumped at flow rate of 1 ml/min and eluent was monitored at 234 nm. Methods 2 & 3 were colorimetric estimations based on condensation reaction between Pravastatin and vanillin in presence of concentrated Sulphuric acid resulting in the formation of blue colored chromogen which showed a linearity range 2–12 μg/ml at λmax of 610nm and a oxidative coupling reaction Pravastatin and chromogenic agent MBTH (3-Methyl -2-benzothiazolinonehydrazone hydrochloride) in presence of cerric ammonium sulphate which obeyed Beer's law in th concentration range of 2–10 μg/ml at absorption maxima of 616nm respectively. The three methods were validated statistically following ICH guidelines.