DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF NIACIN AND SIMVASTATIN IN TABLET DOSAGE

This work is concerned with application of simple, accurate, precise and highly selective reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of Niacin (NA) and Simvastatin (SIM) in combined dosage form. Chromatographic separation was achieved by isocratic mode using a reverse phase C18 column (phenomenx, 150 × 4.6 mm i.d.). The mobile phase composed methanol: water in ratio 85:15 water consisting of Triethylamine (TEA) (0.05%v/v) v/v at flow rate of 1 ml/min pH was adjusted to 4 with orthophosporic acid. Detection was carried out using a UV-vis detector at 250 nm. The mean retention time of NA and SIM was found to be 1.8 min and 8.5 min. respectively. The method was found to be linear in the range of 80–120 μg/ml with mean recovery of 99.39% for NA and 99.18% for SIM. The correlation coefficients for both NA and SIM were close to 1. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for simultaneous determination of NA and SIM in routine analysis of formulation.