Development and Validation of RP-HPLC Method for Estimation of Efavirenz in Bulk and in Tablet Dosage forms

A simple, precise, rapid, accurate and economic high performance liquid chromatographic (HPLC) method has been developed for the estimation of Efavirenz in bulk and its tablet dosage forms. A sunfire C₁₈ column was used for the determination of efavirenz using methanol and acetonitrile as mobile phase in the ratio of 7:3 v/v, at ambient temperature and the detector was set at 249 nm. The Linearity of efavirenz was found in the range of 10-400 μg/ml with acceptable value of correlation coefficient 0.9997. The method was validated for accuracy, precision, robustness and recovery studies. The recovery of the drug was found to be 99.89%, relative standard deviation was found to be less than 2% for precession studies and method was found to be robust with the varying condition of flow rate (±10%), wavelength of detection (±5nm), column oven temperature (±5°C). The suitability of the developed HPLC method for quantitative determination of efavirenz was proved by validation in accordance with the ICH guidelines. The developed method can be successfully applied in the routine analysis of commercial pharmaceutical tablets.