| Literature DB >> 27723524 |
Geetha Bhavani K1, Bala Murali Krishna K2, Srinivasu N3, Ramachandran D4, V V S S Raman N5, Hari Babu B6.
Abstract
A sensitive LC-MS method was developed for the determination of tert-butyl 2-[4-(pyridine-2-yl) benzyl] hydrazine carboxylate (GTI-A), a genotoxic impurity in Atazanavir sulphate drug substance. The method was validated as per International Council for Harmonization guidelines, for QL, DL, linearity and accuracy. The QL and DL values obtained were 1.1ppm and 0.3ppm respectively. The Correlation coefficient found for the linearity study was 0.999. The % recovery of the added impurity in the range of 96.4-100.4 ensured the accuracy of the method.Entities:
Keywords: Atazanavir; DL; GTI; ICH; LC–MS; QL
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Year: 2016 PMID： 27723524 DOI： 10.1016/j.jpba.2016.09.025
Source DB: PubMed Journal: J Pharm Biomed Anal ISSN： 0731-7085 Impact factor: 3.935