LC-MS/MS studies of ritonavir and its forced degradation products.
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.
Rao
R Nageswara
RN
Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Tarnaka, Hyderabad, India. rnrao55@yahoo.com
Ramachandra
B
B
Vali
R Mastan
RM
Raju
S Satyanarayana
SS
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D017320:HIV Protease Inhibitors / Q000032:analysis* / Q000737:chemistry; D006868:Hydrolysis; D019438:Ritonavir / Q000032:analysis* / Q000737:chemistry; D053719:Tandem Mass Spectrometry / Q000379:methods*
D017320:HIV Protease Inhibitors; D019438:Ritonavir