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

The present study aimed to develop a novel RP-HPLC Method for the estimation of Niacin and Lovastatin in Bulk and oral solid dosage form. For the simultaneous estimation of lovastatin and niacin in a combined dosage form, a straightforward, accurate, and speedy HPLC method has been created and validated. Chromatographic separation of the two drugs was performed on a Purospher BDS C8 column (150 mm× 4.6 mm id, 5µm particle size). 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 for niacin 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. According to the International Conference on Harmonization (ICH) Q2 (R1) guidelines, the optimised method performed well in terms of specificity, linearity, detection and quantitation limits, precision, and accuracy. It has been shown that this assay can be used to regularly quantify lovastatin and niacin in tablet dosage form. High percentage recovery of drug shows the method is free from inference of excipients present in the formulation. The proposed method was found suitable for simultaneous analysis of NI and LT can be used for routine quality control of their bulk drug mixture and their combined dosage form.