A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION, STRESS DEGRADATION STUDIES OF EFAVIRENZ IN BULK AND PHARMACEUTICAL DOSAGE FORM

A new RP-HPLC method for the quantitative determination of Efavirenz was developed and validated as per ICH guidelines. The drug was injected into Hypersil Gold C18 column (150×4.6 mm i.d, 5µ) maintained at ambient temperature and effluent monitored at 252 nm. The mobile phase consisted of Acetonitrile [HPLC grade]: 25mM Ammonium acetate (50: 50V/V). The flow rate was maintained at 1.5 ml/min. The developed method shows high specificity for Efavirenz. The calibration curve for Efavirenz was linear from 0.066 and 3.024µg/ml respectively (r2 for Efavirenz=0.999).The proposed method was adequate, sensitive, reproducible and specific for the determination of Efavirenz in bulk and pharmaceutical dosage forms. Keywords: Efavirenz, Hypersil Gold C18 column.