A simple, sensitive, precise and stability-indicating GC-MS method for the analysis of Clopidogrel bisulfate was developed and validated. The chromatographic separation was performed on Shimadzu -GCMS-QP2010 Plus device equipped with META-5X column (30.0 m X 0.32 mm X 0.25 mm), carrier gas was He, and gas flow rate 1.27 ml/min. Mass spectra were obtained by electron impact (EI) ionization at 70 eV, the qualitative analysis was made in Scan mode while the quantitative analysis was in SIM mode. The retention time of Clopidogrel bisulfate was about 17.2 min. Clopidogrel bisulfate was subjected to acid and alkali hydrolysis, oxidation and photo-degradation. The method was validated for different parameters. The results indicate that the drug was susceptible to degradation. All the peaks of degraded products were resolved from the active pharmaceutical ingredient with significant different retention times. As the method could effectively separate the drug from its degradation products, it could be employed as a stability- indicating method
Journal of Chemical and Pharmaceutical Sciences.
2014.
A novel GC-MS for the determination of Clopidogrel bisulfate in bulk and pharmaceutical dosage forms
الطلاب
الهيئة التعليمية
الخريجين
الكليات
