ABSTRACT:
A simple, precise, rapid and accurate reverse phase HPLC method in isocratic mode has been developed for the estimation of Efavirenz in tablet dosage form. A Hypersil BDS C18, 250x4.6 mm, 5 µm partical size, with mobile phase consisting of acetonitrile and 0.03 M KH2PO4 in water (pH adjusted to 3.2 with orthophosphoric acid) in the ratio of 60:40 v/v was used. The flow rate was 0.8 ml/min and the effluents were monitored at 260 nm. The retention time was 10.549 min for Efavirenz. The detector response was linear for Efavirenz are in the range of 12-144 mcg/ml respectively. The respective linear regression equation being Y=19958.961x+23536.8626 is for Efavirenz. The limit of detection (LOD) for 0.12µg/ml and the limit of quantification (LOQ) for Efavirenz were found to be 0.36µg/ml respectively. The percentage assay of Efavirenz was 98.28%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Efavirenz in bulk drug and in its pharmaceutical dosage form.