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 FORM
AbstractA 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.
Article Information
56
5673-5682
908
969
English
IJPSR
B. K. Kumar *, V. G. Sekara and K. B. C. Shekar
Department of Pharmaceutical Analysis, Sri Venkateswra College of Pharamacy, Chittoor, Andhra Pradesh, India.
karun.bannuri@gmail.com
18 February 2019
28 March 2019
17 April 2019
10.13040/IJPSR.0975-8232.10(12).5673-82
01 December 2019