Determination of Atazanavir in the Presence of its Degradation Products by a Stability-Indicating LC Method |
| |
| Authors: | U Seshachalam D V L Narasimha Rao B Haribabu K B Chandrasekhar |
| |
| Institution: | (1) Quality Assurance, Matrix Laboratories Limited, 1-1-151/1, Sairam Towers, Alexander Road, Secunderabad, Andhra Pradesh, 500 003, India;(2) Process Reseacrh Laboratory, Matrix Laboratories Limited, Secunderabad, Andhra Pradesh, 500 003, India;(3) API Technical services, Matrix Laboratories Limited, Secunderabad, Andhra Pradesh, 500 003, India;(4) Department of Chemistry, JNTU College of Engineering, Ananthapur, Andhra Pradesh, 515002, India |
| |
| Abstract: | 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. |
| |
| Keywords: | Column liquid chromatography Stability-indicating method Forced degradation Drug substance Atazanavir |
| 本文献已被 SpringerLink 等数据库收录！ |
|
