DEVELOPMENT AND VALIDATION OF A RP – LC METHOD FOR DISSOLUTION TEST OF EFAVIRENZ TABLETS AND ITS APPLICATION TO DRUG QUALITY CONTROL STUDIES
Anindita Behera, Dannana Gowri Sankar, Swapan Kumar Moitra, Sudam Chandra Si
Asian Journal of Pharmaceutical and Clinical Research
A liquid chromatographic method is developed to evaluate a new dissolution profile of Efavirenz in tablet dosage form. The dissolution method is developed by considering different factors like medium composition, pH, surfactant concentration and rotation speed. The dissolution test is validated using a high-performance liquid chromatographic method (HPLC). HPLC method is developed using ammonium acetate buffer (pH 7.5): acetonitrile in the ratio 40:60 as mobile phase in a C18 column. The dissolution conditions are achieved using paddle, 900 ml of medium containing water with 2% (w/v) of sodium lauryl sulfate at a rotation speed of 50 rpm. The developed dissolution method follows zero order kinetics. The reverse phase chromatographic method is found to be accurate, precise and specific. Both the methods are validated according to ICH guidelines and applied successfully for the quality control of commercial Efavirenz tablets.
Dissolution, Efavirenz, Method development, HPLC, Validation