Journal of Pharmacy & Pharmaceutics
Long-term stability study of complex darunavir: β-cyclodextrin
- 1Department of Pharmaceutics, School of Pharmaceutical Sciences of Araraquara, Univ Estadual Paulista - UNESP, Araraquara, São Paulo, Brazil
- 2Center for Research in Natural and Synthetic Products, Department of Physics and Chemistry, School of Pharmaceutical Sciences of Ribeirão Preto, Universidade de São Paulo, Ribeirão, Preto, Brazil
- 3Department of Physical Chemistry, Institute of Chemistry, Univ Estadual Paulista - UNESP, Araraquara, São Paulo, Brazil
Ana Carolina Kogawa, Postgraduate Program in Pharmaceutical Sciences, School of Pharmaceutical Sciences of Araraquara, UNESP, Road CEP 14801-902, Araraquara, SP, Brazil, Tel: 55 16 3301 4681; Fax: 55 16 3301 6967; E-mail: email@example.com
Kogawa, A.C., et al. Long-Term Stability Study of Complex Darunavir: β-Cyclodextrin. (2016) J Pharm Pharmaceutics 3(1): 1- 5.
© 2016 Kogawa, A.C. This is an Open access article distributed under the terms of Creative Commons Attribution 4.0 International License.
Keywordsβ-cyclodextrin; Darunavir; Degradation products; LC-MS; Long-term stability
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.