Development of Efficient Analytical method for the multicomponent analysis of Pravastatin Sodium and Nebivolol Hydrochloride in Bulk Drug by RP-HPLC

Abstract

Cardiovascular diseases are managed through multi drug regimens. For better patient compliance and cost effectiveness, desired therapeutic efficacy is achieved through combination of more than two drugs in single dosage form. Nebivolol Hydrochloride is β1 receptor blocker and Pravastatin sodium exhibits its pharmacological action through inhibition of cholesterol synthesis. Both drugs are therapeutically compatible and can be administered in single dose formulation. A review of the literature found that there was no effective strategy for the selected drug combination. As a result, an attempt was made to establish a simple, efficient, sensitive, specific, and rapid method for simultaneously estimating Pravastatin sodium and Nebivolol hydrochloride in bulk drugs using RP-HPLC.Column C-18 (Shim-pack) 250 x 4.6 mm, particle size 5 m, mobile phase acetonitrile and water in the ratio 20:80 at 257 nm were found to be the optimal chromatographic conditions. Pravastatin sodium and Nebivolol hydrochloride had retention times of 2.092 and 3.623 minutes, respectively, with average percentage recovery of 99.38% and 99.54%, respectively.The proposed technique was found to be in accordance with the guidelines of the International Conference on Harmonization (ICH).