Development and validation of a selective, sensitive and stability indicating UPLC-MS/MS method for rapid, simultaneous determination of six process related impurities in darunavir drug substance

• Main Authors: Reddy A., Vijaya Bhaskar, Yusop, Zulkifli, Jaafar, Jafariah, Aris, Azmi, A. Majid, Zaiton, Umar, Khalid, Talib, Juhaizah
• Format: Article
• Published: Elsevier B. V. 2016
• Subjects: QD Chemistry
• Online Access: http://eprints.utm.my/id/eprint/69181/; http://dx.doi.org/10.1016/j.jpba.2016.05.026

In this study a sensitive and selective gradient reverse phase UPLC-MS/MS method was developed for the simultaneous determination of six process related impurities viz., Imp-I, Imp-II, Imp-III, Imp-IV, Imp-V and Imp-VI in darunavir. The chromatographic separation was performed on Acquity UPLC BEH C1...