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J Pharm Biomed Anal. 2017 Jan 5;132:156-158. doi: 10.1016/j.jpba.2016.09.025. Epub 2016 Sep 26.

Determination of genotoxic impurity in atazanavir sulphate drug substance by LC-MS.

Author information

1
JMJ College for Womens, Tenali, Andhra Pradesh, India.
2
Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. Andhra Pradesh, India.
3
Department of Science and Humanities, Vignan University, Vadlamudi, Andhra Pradesh, India.
4
Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. Andhra Pradesh, India. Electronic address: dittakavirc@gmail.com.
5
Hetero Drugs limited (R&D), Hyderabad, Telangana, India.
6
Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. Andhra Pradesh, India. Electronic address: dr.b.haribabu@gmail.com.

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.

KEYWORDS:

Atazanavir; DL; GTI; ICH; LC–MS; QL

PMID:
27723524
DOI:
10.1016/j.jpba.2016.09.025
[Indexed for MEDLINE]

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