Stability-indicating HPLC method for the determination of efavirenz in bulk drug and in pharmaceutical dosage form.

A rapid and accurate isocratic HPLC method was developed and validated for the assay of Efavirenz (EFA) in bulk and pharmaceutical dosage forms. The chromatographic conditions comprise of a Novapak phenyl column. A mixture of phosphate buffer and Acetonitrile was used as mobile phase. Quantitation was achieved by UV detection at 247 nm. A linear response (r2 ≥ 0.999) was observed in the range of 0.05 - 0.15 mg/mL. The method was validated for accuracy and precision. The proposed method can be used for quality control assay of EFA in bulk and in finished dosage form and for the stability studies as the method separates EFA from its degradation products and excipients.   Key words: Efavirenz, stability indicating HPLC, dosage form, UV detection.