Development and Validation of an Analytical Method for the Identifi cation of 2-Nitrophenyl(phenyl)sulfane as Potential Genotoxic Impurity of Quetiapine Fumarate at Trace Levels by High-Performance Thin-Layer Chromatography.

Autor: Miniyar, Pankaj B., Kulkarni, Resham D., Thomas, Asha B., Chitlange, Sohan S.
Zdroj: Journal of Planar Chromatography - Modern TLC; 2019, Vol. 32 Issue 6, p511-516, 6p
Abstrakt: Genotoxic impurities can be described as impurities that can induce genetic mutations and chromosomal breaks, or that damage the genetic information within a cell, which may lead to cancer. The European Medical Agency (EMA) and the United States Food and Drug Administration (US FDA) have set a threshold of toxicological concern (TTC) of genotoxic impurities 1.5 µg per day. In a continuous effort to develop an analytical method for the estimation of genotoxic impurities in quetiapine fumarate, a sensitive, simple, and precise high-performance thin-layer chromatography method has been developed and validated for the determination of 2-nitrophenyl (phenyl)sulfane as a genotoxic impurity at trace levels. The limits of detection (LOD) for quetiapine fumarate and 2-nitrophenyl (phenyl)sulfane were found to be 5.11 and 15.5 ng per band, whereas the limits of quantification (LOQ) were observed 0.09 and 0.3 ng per band, respectively. The calibration curve for 2-nitrophenyl (phenyl)sulfane was linear over the concentration range of 10 to 50 ng per band. The method was found to be specific, precise, linear, and accurate for the estimation of 2-nitrophenyl (phenyl)sulfane at trace levels in quetiapine fumarate. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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