Abstract:
:Indinavir sulphate was subjected to forced degradation under hydrolysis (acidic, basic and neutral), oxidation, photolysis and thermal stress as prescribed by ICH guidelines. It was degraded under acidic, basic, neutral and oxidative stress conditions, while it was stable under other conditions. After degradation total eight degradation products were formed. The degradation products were identified and their separation was accomplished on Waters XTerra(®) C(18) column (250 mm × 4.6mm i.d., 5 μm) using 20mM ammonium actate:acetonitrile as (50:50, v/v) mobile phase in an isocratic elution mode by LC. The method was extended to LC-MS/MS for characterization of the degradation products and the fragmentation pathways were proposed. The proposed structures of degradation products were also confirmed by HRMS studies. No previous reports were found in the literature regarding the characterization of degradation products of indinavir sulphate.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Rao RN,Vali RM,Raju SSdoi
10.1016/j.jpba.2012.10.025subject
Has Abstractpub_date
2013-02-23 00:00:00pages
101-10eissn
0731-7085issn
1873-264Xpii
S0731-7085(12)00565-1journal_volume
74pub_type
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