RP-HPLC separation and characterization of unknown impurities of a novel HIV-protease inhibitor Darunavir by ESI-MS
Ramisetti Nageswara Rao1, Bondigalla Ramachandra, Kondapalli Santhakumar
1D-215, Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Tarnaka, Hyderabad 500 607, India. rnrao55@yahoo.com
Abstract:
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.
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