title: Determination of genotoxic impurity in atazanavir sulphate drug substance by LC-MS.
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.
authors.affiliation: JMJ College for Womens, Tenali, Andhra Pradesh, India.
authors.forename: Geetha Bhavani
authors.initials: GB
authors.lastname: K
authors.affiliation: Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. Andhra Pradesh, India.
authors.forename: Bala Murali Krishna
authors.initials: BMK
authors.lastname: K
authors.affiliation: Department of Science and Humanities, Vignan University, Vadlamudi, Andhra Pradesh, India.
authors.forename: Srinivasu
authors.initials: S
authors.lastname: N
authors.affiliation: Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. Andhra Pradesh, India. Electronic address: dittakavirc@gmail.com.
authors.forename: Ramachandran
authors.initials: R
authors.lastname: D
authors.affiliation: Hetero Drugs limited (R&D), Hyderabad, Telangana, India.
authors.forename: V V S S Raman
authors.initials: VVSSR
authors.lastname: N
authors.affiliation: Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. Andhra Pradesh, India. Electronic address: dr.b.haribabu@gmail.com.
authors.forename: Hari Babu
authors.initials: HB
authors.lastname: B
mesh_terms: D000069446:Atazanavir Sulfate / Q000737:chemistry*; D002021:Buffers; D002853:Chromatography, Liquid; D004340:Drug Contamination; D017320:HIV Protease Inhibitors / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D016014:Linear Models; D013058:Mass Spectrometry; D009153:Mutagens; D015203:Reproducibility of Results
chemical_list: D002021:Buffers; D017320:HIV Protease Inhibitors; D009153:Mutagens; D000069446:Atazanavir Sulfate
keywords: Atazanavir; DL; GTI; ICH; LC–MS; QL