Simultaneous Determination of Niacin and Lovastatin in Tablet Dosage Form by Reverse Phase HPLC

Abstract

A simple, specific and sensitive reverse phase high performance liquid chromatographic method was developed and validated for simultaneous determination of niacin and lovastatin in bulk drugs and formulation. The separation was effected on a kromasil C₁₈ column (250 mm × 4.6 mm; 5μ) using a mobile phase consisting of acetonitrile and 0.02 M potassium dihydrogen phosphate and 0.01 M dipotassium hydrogen orthophosphate (pH 5) in the ratio of 80:20 (v/v) at a flow rate of 1 mL/min. UV detector was programmed at 254 nm. The retention times for niacin and lovastatin were 2.1 and 5.4 min respectively. All the validation parameters were in acceptable range. The developed method was effectively applied to quantitate amount of niacin and lovastatin and from tablets. Calibration curves were linear over the ranges of 0.4-2.4 μg/mL for lovastatin and 10-60 μg/mL for niacin. The proposed method was validated as per the ICH and USP guidelines. The method is accurate and precise and found to be suitable for the quantitative analysis of both the drugs individually and in combination in tablet dosage forms.