A novel high-performance thin-layer chromatographic (HPTLC) analytical method has been developed and optimized for the quantification of quetiapine fumarate (QF) and its two genotoxic impurities in drug substance and drug product. The desired separation was achieved on 60F₂₅₄ pre-coated HPTLC plates using combination of green solvents, ethyl acetate‒ethanol‒n-heptane (5:1:4, V/V) as developing solvents. The detection wavelength used for quantification was 229 nm. QF and its two related genotoxic impurities, namely, 2-chloroaniline and 2-aminodiphenylsulfide, were well resolved from one another with retention factor values of 0.13 ± 0.02, 0.57 ± 0.02 and 0.76 ± 0.02, respectively. The optimized method was validated according to the guidelines laid down by the International Council for Harmonisation. The linearity was determined in the range of 100–600 ng/spot for QF and 10‒60 ng/spot for its two related genotoxic impurities; R² ≥ 0.993. The method exhibited precision along with good accuracy, where 0.51, 0.86 and 1.86. The percentage recoveries obtained for 2-chloroaniline and 2-aminodiphenylsulfide were 99.04‒101.04%. The developed method can be successfully used for the analysis of drug samples.

开发并优化了一种新型高效薄层色谱 (HPTLC) 分析方法，用于定量分析原料药和制剂中的富马酸喹硫平 (QF) 及其两种基因毒性杂质。期望分离在60F达到₂₅₄使用绿色溶剂，乙酸乙酯-乙醇的组合预涂覆的HPTLC板Ñ 1：庚烷（5 4，V / V) 作为展开溶剂。用于定量的检测波长为 229 nm。QF 及其两种相关的遗传毒性杂质，即 2-氯苯胺和 2-氨基二苯硫醚，彼此分离良好，保留因子值分别为 0.13 ± 0.02、0.57 ± 0.02 和 0.76 ± 0.02。优化的方法根据国际协调委员会制定的指南进行了验证。QF 的线性范围为 100–600 ng/点，其两种相关基因毒性杂质的线性范围为 10–60 ng/点；[R ² ≥ 0.993。该方法表现出精密度和良好的准确度，分别为 0.51、0.86 和 1.86。2-氯苯胺和2-氨基二苯硫醚的回收率为99.04-101.04%。所开发的方法可成功用于药物样品的分析。