Novel HPLC method for statins in their dosage forms

ABSTRACT

The statins form a class of hypolipidemic drugs used to lower cholesterol in people with or at risk of Coronary Heart Diseases [CHD] through inhibitionof 3-Hydroxy-3-MethylGutaryl-coenzyme A [HMC-CoA] reductase, which is the rate-limiting enzyme of the mevalonate pathway of cholesterol synthesis. Aorvastatin, lovastatin, rosuvastatin and simvastatin are commonly marketed statins. Previous studies involved estimation of statins either separately or in combination only through gradient elution. The novelty in the present study involved the use of a reversed phase HPLC C[18] column in one isocratic run through hydrolysis into the hydroxyacids of the mixture components via pH gradient vehicle. The study develops rapid, precise, accurate and reproducible method to determine these statins in a mixture and in their dosage forms. The method was validated over a wide concentration range [0.08 micro g to 3.2 micro g], its repeatability was ascertained and the applicability is confirmed