A Simple and Sensitive Method for the Ultra Trace Determination of Potential Genotoxic Impurities in Abacavir Sulfate by LC-MS
Journal Title: Chemical Methodologies - Year 2018, Vol 2, Issue 0
Abstract
A new LC-MS based method was developed to detect three potential genotoxic impurities namely, N',N'''-(4,6-dichloropyrimidine-2,5-diyl)bis[N,N-dimethyl(imidoformamide)]} (Impurity-I), {N-(2-amino-4-chloro-6-{[(1S,2R)-2-(hydroxymethyl)cyclopent-3-en-1-yl]amino}pyrimidin-5-yl)formamide} (Impurity-II) and {(1R,5S)-5-[(2,5-diamino-6-chloropyrimidin-4-yl)amino]cyclopent-2-en-1-yl}methanol (Impurity-III), at low level in Abacavir sulfate, a nucleoside reverse transcriptase inhibitor. It utilizes Zorbax phenyl hexyl column (150 mm x 4.6 mm, 3.5 μm) with electrospray ionization in selected ion monitoring (SIM) mode for quantitation of these PGIs. The method is able to quantify Impurity-I at 0.74 ppm, Impurity-II and Impurity-III at 0.73 ppm with respect to 5.0 mg/mL of Abacavir sulfate. The method was found to be linear in the range of LOQ to 150% of Toxicological Threshold Concentration level of 2.5 ppm. The correlation coefficients of PGI’s obtained were >0.999 in each case. The method accuracy of these PGI’s is in the range between 88.7-115.0%. The method is sensitive, specific, linear, accurate, precise and meets the criteria of validation as per International Conference on Harmonization.
Authors and Affiliations
Mohit Jain, Saroj Kumar Paul, Madhava Rao Mannam, Sujeet Shrivastava, Hiriyanna S. G. , Pramod Kumar
Keywords
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- EP ID EP648072
- DOI 10.22034/chemm.2018.66185
- Views 88
- Downloads 0
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