RP-HPLC method development and validation for quantification of darunavir ethanolate in tablet dosage form

[摘要] A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for quantification of Darunavir ethanolate in bulk and its tablet dosage form. The separation was carried out on Shiseido C8 (250 × 4.6mm; 5μm) column at ambient temperature using phosphate buffer pH 3: acetonitrile (40:60) as eluent. The flow rate was 1.0 ml/min and effluent was detected at 270 nm. The retention time of Darunavir ethanolate was 4.30 min. The percentage recovery was within the range between 99.46% and 100.17% for Darunavir ethanolate. The linear ranges were found to be 5-15μg/ml (r2 = 0.9997) for Darunavir ethanolate. The percentage relative standard deviation for accuracy and precision was found to be less than 2%. Hence, the method could be successfully applied for routine analysis of Darunavir ethanolate in pharmaceutical formulations.

[学科分类] 药理学