LONG-TERM STABILITY STUDY OF COMPLEX DARUNAVIR:Β-CYCLODEXTRIN

Darunavir, a protease inhibitor most widely used in the treatment of HIV infection, was complexed with β-cyclodextrin due to the low solubility in water and its poor bioavailability. This research describes the study the long-term stability of the complex darunavir: β-cyclodextrin which was kept in a climatic chamber for 24 months at 30°C ± 2°C and 75 % UR ± 5 %. The samples were analyzed using LC-MS, 250 mm × 4.6 mm CN Luna column, water + 0.1 % glacial acetic acid: acetonitrile + 0.1 % glacial acetic acid 60:40 (v/v) as mobile phase, flow rate of 1.0 mL min-1, UV detection at 268 nm and ambient room temperature (25°C) before the start of study and thereafter 3, 6, 9, 12, 18 and 24 months. The data obtained associated with the infrared, TG, DSC and X-ray diffraction analysis was sufficient to study the behavior of complex darunavir: β-cyclodextrin. The results of this research indicate that the stability of the complex darunavir: β-cyclodextrin is high under conditions associated of temperature and humidity.