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A validated HPTLC method for the quantitative determination of duloxetine hydrochloride and 1-naphthol in bulk and pharmaceutical formulation
JPC - Journal of Planar Chromatography - Modern TLC ( IF 1.6 ) Pub Date : 2020-08-19 , DOI: 10.1007/s00764-020-00045-w
Nessreen S. Abdelhamid , Ibrahim A. Naguib , Basma H. Anwar , Maimana A. Magdy

Duloxetine hydrochloride is an anti-depressant drug, while 1-naphthol is one of its hepatotoxic impurities. So, there was an urgent need to do simultaneous analysis for both the drug and its toxic impurity. Therefore, a validated high-performance thin-layer chromatography (HPTLC) method was established for the simultaneous separation and quantification of duloxetine hydrochloride and 1-naphthol in their binary mixture and pharmaceutical formulation. The utilized developing system consisted of a mixture of chloroform–ethyl acetate–benzene–33% ammonia solution (6:3:1:0.1, v/v). Densitometric scanning was used to detect the separated peaks at 233 nm using an ultraviolet detector. The validation of the estimated method was performed according to the International Conference on Harmonization guidelines. The results indicated that it can be used for the quality control analysis of the proposed mixture. The developed method showed advantages over the previously published TLC methods of having higher sensitivity and allowing the determination of duloxetine hydrochloride with and in the presence of its toxic impurity 1-naphthol.



中文翻译:

经过验证的HPTLC方法可定量测定散装和药物制剂中盐酸度洛西汀和1-萘酚

盐酸度洛西汀是一种抗抑郁药,而1-萘酚是其肝毒性杂质之一。因此,迫切需要对药物及其有毒杂质进行同时分析。因此,建立了一种经过验证的高效薄层色谱法(HPTLC),用于同时分离和定量盐酸度洛西汀和1-萘酚的二元混合物和药物制剂。利用的显影系统由氯仿-乙酸乙酯-苯-33%氨溶液的混合物(6:3:1:0.1,v / v)。使用紫外检测器使用光密度扫描法检测233 nm处的分离峰。估计方法的验证是根据国际协调会议指南进行的。结果表明,该方法可用于所建议混合物的质量控制分析。所开发的方法显示出优于先前发布的TLC方法的优点,该方法具有更高的灵敏度并允许在有毒杂质1-萘酚存在下和在其存在下测定盐酸度洛西汀。

更新日期:2020-08-19
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