GRADIENT HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR DETERMINATION OF RELATED SUBSTANCES IN [(3aS, 4R, 6aR)-2, 3, 3a, 4, 5, 6a-HEXAHYDROFURO [2, 3-b] FURAN-4-YL] N-[(2S, 3R)-4-[(4-AMINOPHENYL) SULFONYL-(2-METHYLPROPYL) AMINO]-3-HYDROXY-1-PHENYLBUTAN-2YL] CARBAMATE DOSAGE FORMAbstract
A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for quantification of Darunavir in bulk and its tablet dosage form. The separation was carried out on Zorbax Eclipse XDB C18 (150 × 4.6 mm; 5 µm) column at 35 °C temperature using ammonium acetate buffer as mobile phase-A, acetonitrile (100%) as mobile phase-B. The flow rate was 1.0 ml/min and effluent was detected at 265 nm. The retention time of Darunavir propylene glycolate was 31.34 min. The percentage recovery was within the range between 95.46% and 100.17% for Darunavir propylene glycolate. The linear ranges were found to be 0.086-3.084 µg/ml (r2 = 0.9997) for Darunavir propylene glycolate. The percentage relative standard deviation for accuracy and precision was found to be less than 5.0%. Hence, the method could be successfully applied for routine analysis of Darunavir in pharmaceutical formulations.
B. K. Kumar *, V. G. Sekara and K. B. C. Shekar
Department of Pharmaceutical Analysis, Sri Venkateswra College of Pharamacy, Chittoor, Andhra Pradesh, India.
18 February 2019
28 March 2019
17 April 2019
01 December 2019