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7491447 
Journal Article 
Validated stability indicating LC-PDA-MS method to investigate pH rate profile and degradation kinetics of efavirenz and identification of hydrolysis product by LCMS 
Gadkari, T; Chandrachood, P; Ruikar, A; Tele, S; Deshpande, N; Salvekar, J; Sonawane, S 
2010 
1 
International Journal of Pharmacy and Pharmaceutical Sciences
ISSN: 2656-0097
EISSN: 0975-1491 
2 
1 
169-176 
English 
A rapid, selective and sensitive stability indicating liquid chromatography-photo diode array-mass spectrometry (LC-PDA-MS) assay was developed and validated for the quantitative analysis of efavirenz in presence of its degradation products. A 150 mm ODS column was used with mobile phase consisting of acetonitrile-ammonium acetate (100 mM) (60:40, v/v) as mobile phase. Quantification was achieved by UV detection at 246 nm, on the basis of peak area. Forced degradation studies were performed on a bulk sample of efavirenz using 0.1 M hydrochloric acid, 0.1M sodium hydroxide, 0.33% hydrogen peroxide, heat (70°C), and photolytic degradation. The method was linear in the range of 0.5 - 60 μg mL-1 efavirenz concentration. Excellent recoveries (99.2 - 101.3%) proved that the method was sufficiently accurate. The LOD and LOQ were found to be 50.0 and 160 ng mL-1, respectively. Efavirenz found unstable in alkaline condition. The alkaline hydrolysis product of efavirenz was identified on single quadrupole mass spectrometer. The hydrolysis product was proposed from mass spectral data to be amino alcohol formed by hydrolysis of cyclic carbamate. The alkaline hydrolysis of drug followed apparent first order degradation kinetics. The half-life of drug in alkaline solution was found to be 69 h. 
Degradation kinetics; Efavirenz; Forced degradation; LC-PDA-MS; pH-Rate profile; Stability indicating assay; acetonitrile; aminoalcohol; ammonium acetate; carbamic acid; efavirenz; hydrochloric acid; hydrogen peroxide; sodium hydroxide; accuracy; alkalinity; article; assay; concentration (parameters); degradation kinetics; drug degradation; half life time; heat; hydrolysis; liquid chromatography; liquid chromatography photo diode array mass spectrometry; mass spectrometer; mass spectrometry; methodology; pH; photolysis; quantitative analysis; validation process 
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