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首页> 外文期刊>RSC Advances >Simultaneous estimation of dimenhydrinate, cinnarizine and their toxic impurities benzophenone and diphenylmethylpiperazine; in silico toxicity profiling of impurities
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Simultaneous estimation of dimenhydrinate, cinnarizine and their toxic impurities benzophenone and diphenylmethylpiperazine; in silico toxicity profiling of impurities

机译：同时估计二烯烃，胶质素及其有毒杂质二苯甲酮和二苯基甲基哌嗪;在杂质的硅毒性分析中

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摘要

The British Pharmacopeia (BP) reported that the carcinogenic and hepatotoxic, benzophenone (BZP) is a dimenhydrinate (DMH) impurity. On the other hand, cinnarizine (CIN) is reported to have five impurities (A–E). The toxicity profile of CIN impurities was studied and the in silico data revealed that impurity A [1-(diphenylmethyl)piperazine] (DPP) was the most toxic CIN impurity, and hence it was selected during this work. TLC-densitometric method was developed for separation and simultaneous quantitation of DMH, CIN and their toxic impurities. In the proposed method hexane?:?ethanol?:?acetone?:?glacial acetic acid (7?:?3?:?0.7?:?0.5, by volume) with UV scanning at 225 nm were used. Method validation was carried out according to ICH guidelines and linearity was achieved in the range 0.2–4, 0.5–5, 0.1–2.0, and 0.05–2.2 μg per band for DMH, CIN, BZP and DPP, respectively. On the application of the method to pharmaceutical formulation, no interference from additives was observed. The greenness of the method was evaluated using the analytical eco-scale and the results revealed the low negative environmental impact of the developed method.
机译：英国药典（BP）报道了致癌和肝毒性，二苯甲酮（BZP）是杂质（DMH）杂质。另一方面，据报道，Cinnarizine（CIN）有五种杂质（A-E）。研究了CIN杂质的毒性分布，硅数据中的杂质A [1-（二苯基甲基）哌嗪]（DPP）是最有毒的CIN杂质，因此在该工作期间选择它。开发了TLC密度计量方法，用于分离和同时定量DMH，CIN及其有毒杂质。在所提出的方法己烷中？：乙醇？：α：α：α：α：α：冰醋酸（7？：Δ3？：Δ0.7？：Δ0.0，按体积）使用紫外线扫描在225nm。方法验证根据ICH指南，分别在0.2-4,0.5-5,0.1-2.0的范围内实现，分别为DMH，CIN，BZP和DPP的0.05-2.2μg。在该方法的应用对药物制剂的应用中，没有观察到添加剂的干扰。使用分析生态规模评估该方法的绿色，结果显示了开发方法的低负环境影响。

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