Development and Validation of RP- HPLC Method for Simultaneous Determination of Niacin (Extended Release) and Lovastatin in Oral Solid Dosage Form

A simple, precise and rapid HPLC method has been developed and validated for the estimation of Lovastatin and niacin simultaneously in combined dosage form. Chromatographic separation of the two drugs was performed on a Purospher BDSC8 column (150mm×4.6mmid, 5µm particlesize).The mobile phase used was a mixture of 0.1% v/v triethylamine (pH 5.0), containing 20 mM of ammonium acetate buffer: methanol (30:70% v/v).Detection was performed at 237nm and sharp peaks were obtained forniacin and Lovastatin at retention times of 3.2±0.01 min and.6.4±0.01 min respectively.The calibration curve was linear in the concentration range 100-700µg/ml for niacin 3-18µg/ml for Lovastatin; the correlation coefficients were 0.9991 and 0.9992, respectively. The optimized method showed good performance in terms of specificity, linearity, detection and quantitationlimits, precision and accuracy in accordance with the International Conference on Harmonization (ICH) Q2 (R1) guidelines.This assay was demonstrated to be applicable for routine quantitation of Lovastatin and niacin in tablet dosage form.