Abstract

The main aim of the current work is to develop and validate a novel, specific, sensitive, precise, rapid and faster gradient elution by RP HPLC method for estimation of Boceprevir and related impurities in bulk and pharmaceutical dosage forms. No method is available in the literature for the estimation of Boceprevir and also its process related impurity. The chromatographic separation was achieved on X – Terra RP -8, 250 mm X 4.6 mm, 5 μ with mobile phase composed of 0.1 M ammonium acetate in 1000 ml of water (PH 7.5) and acetonitrile using an gradient mode. The temperature is maintained at 45oC, detection was made at 235 nm and the flow rate was maintained at 1.0ml/min. The run rate was 20 min. The developed method was validated according to ICH guide lines and different analytical parameters such as linearity, precision, accuracy, specificity, limit of detection, limit of quantitation were determined. The linearity of calibration curve for each analyte in concentration range of 400 μg/ml – 1200 μg/ml was good. There exists a correlation between peak area and analyte concentration. Relative standard deviation values for boceprevir and its impurity were 0.028 and 0.031 respectively. LOD for the active ingredient and its impurity was found to be 0.20 % and 5.00 % respectively. LOQ for active ingredient and its impurity was found to be 0.60 % and 15.00% respectively. From the above observations, the proposed method was found to be highly sensitive, precise, accurate, robust and fast. The shorter retention time allows the analysis of large number of samples in short period of time and it is cost effective, so it can be successfully applied for routine analysis of active pharmaceutical ingredients and related impurities in bulk and pharmaceutical dosage forms.