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Merck

LC-MS/MS studies of ritonavir and its forced degradation products.

Journal of pharmaceutical and biomedical analysis (2010-07-14)
R Nageswara Rao, B Ramachandra, R Mastan Vali, S Satyanarayana Raju
RÉSUMÉ

Forced degradation of ritonavir (RTV), under the conditions of hydrolysis (acidic, basic and neutral), oxidation, photolysis and thermal stress as prescribed by ICH was studied using LC-MS/MS. Eight degradation products were formed and their separation was accomplished on Waters XTerra C(18) column (250 mm x 4.6 mm i.d., 5 microm) using water:methanol:acetonitrile as (40:20:40, v/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 pathways of decomposition were proposed. No previous reports were found in the literature regarding the characterization of degradation products of ritonavir.

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