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.

中文翻译：

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高效薄层色谱法测定痕量水平的2-硝基苯基（苯基）硫烷富马酸喹硫平潜在遗传毒性杂质的分析方法的建立和验证

遗传毒性杂质可描述为可诱导遗传突变和染色体断裂，或破坏细胞内遗传信息（可能导致癌症）的杂质。欧洲医学机构（EMA）和美国食品药品监督管理局（US FDA）设定了每天1.5μg的遗传毒性杂质的毒理学阈值（TTC）。为了不断开发一种用于估算富马酸喹硫平中遗传毒性杂质的分析方法，开发了一种灵敏，简单且精确的高效薄层色谱方法，并已用于测定2-硝基苯基（苯基）硫烷作为痕量水平的遗传毒性杂质。喹硫平富马酸酯和2-硝基苯基（苯基）硫烷的检测限（LOD）为每条带5.11和15.5 ng，定量限（LOQ）分别为每条带0.09和0.3 ng。在每条带10到50 ng的浓度范围内，2-硝基苯基（苯基）硫烷的校准曲线是线性的。发现该方法对于富马酸喹硫平中痕量水平的2-硝基苯基（苯基）硫烷的估计是特定，精确，线性和准确的。