Determination of Atazanavir in the Presence of its Degradation Products by a Stability-Indicating LC Method
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A forced degradation study was successfully applied for the development of a stability-indicating assay method for the determination of atazanavir in presence of its degradation products. The method was developed and optimized by analyzing the forcefully degraded samples. Degradation of the drug was done under acidic, alkaline, oxidative, photolytic and thermal stress conditions. The proposed method was able to resolve all of the possible degradation products formed during the stress studies. The major impurities are generated in acidic and alkaline conditions. The product was found stable under thermal, photolytic and oxidative conditions. The developed method was validated for determination of atazanavir, and the method was found to be equality applicable to study the impurities formed during routine and forced degradation of atazanavir.
KeywordsColumn liquid chromatography Stability-indicating method Forced degradation Drug substance Atazanavir
- 1.ICH, International Conference on Harmonization of Technical Requirements for the Registration of Drugs for Human use (2003) Stability testing of new drug substances and products Q1A(R2)Google Scholar
- 2.ICH, International Conference on Harmonization of Technical Requirements for the Registration of Drugs for Human use (1996) Stability testing: photo stability testing of new drug substances and products Q1BGoogle Scholar