کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
1221463 | 1494658 | 2013 | 6 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: RP-HPLC separation and characterization of unknown impurities of a novel HIV-protease inhibitor Darunavir by ESI-MS and 2D NMR spectroscopy RP-HPLC separation and characterization of unknown impurities of a novel HIV-protease inhibitor Darunavir by ESI-MS and 2D NMR spectroscopy](/preview/png/1221463.png)
A selective RP-HPLC method for separation and determination of darunavir from its process related substances has been developed and validated. The separation was accomplished on a Hiber, LiChrospher® 60, RP-select B, C8 (250 mm × 4.6 mm, 5 μm) column connected to a photo diode array detector (PDA) using 10 mM phosphate buffer with 0.1% of triethylamine (pH: 4.0 adjusted with orthophosphoric acid)/acetonitrile as a mobile phase under gradient elution. Two unknown impurities of darunavir were isolated and characterized by 1H, 13C, 2D-NMR and mass spectrometry. The method was validated in terms of accuracy, precision, linearity, robustness, LOD and LOQ.
► Separation and determination of darunavir from its ten process related substances by RPLC.
► Isolation and characterization of two unknown impurities of Darunavir by 1H, 13C, 2D-NMR and mass spectrometry.
► Until now, there is no validated LC method reported for determination of process related substances of DRV in literature.
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 75, 5 March 2013, Pages 186–191