ABSTRACT:
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 Lambda max 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.