Simultaneous Estimation of Niacin and Lovastatin by Using Rp-Hplc in Api and Marketed Formulations

Abstract

A novel, precise, accurate, rapid and cost effective isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the estimation of Niacin and Lovastatin in bulk and pharmaceutical dosage forms. The drugs were estimated using Phenomenex Gemini C18 (4.6mm×150mm, 5µm) particle size column. A mobile phase composed of tri ethylamine buffer and methanol in proportion of 32:68 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 248nm. The linearity range obtained was 30-70µg/ml for Niacin and 10-50µg/ml for Lovastatin with retention times (Rt) of 3.297min and 5.405min for Niacin and Lovastatin respectively. The correlation coefficient values were found to be 0.999 & 0.999. Precession studies showed % RSD values less than 2 % for both the drugs in all the selected concentrations. The percentage recoveries of Niacin and Lovastatin were found to be 100.1873% for Niacin and 100.748% for Lovastatin respectively. The assay results of Niacin and Lovastatin were found to be 99.82%. The limit of detection (LOD) and limit of quantification (LOQ) were 2.6µg/ml and 7.8µg/ml for Niacin and 3.4µg/ml 10.2µg/ml for Lovastatin respectively. The proposed method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.