Cyclizine (CYZ) abuse is commonly reported, either through oral or intravenous routes, for its euphoric or hallucinatory effects. The concomitant misuse of CYZ among addicted teenagers leads to life-threatening neuromuscular disorders. Consequently, two green and validated chromatographic methods were developed for the determination of CYZ, an antiemetic drug, in its parenteral formulation in the presence of 1-methyl piperazine and diphenylmethanol (benzhydrol) as the pharmacopeial stated impurities of CYZ. The first method was TLC-densitometry that relied on using a mixture consisting of ethyl acetate:isopropanol:ammonia (9.5:1:0.5, by volume) as a developing system, TLC 60 F254 silica gel plates as a stationary phase and detection of the scanned bands was performed at 210.0 nm. On the other hand, the second method was UPLC which based on the separation of CYZ and its impurities using a mobile phase consisting of ethanol and acidic water at pH 5 adjusted by phosphoric acid in the ratio of (60:40, %v/v) at flow rate 0.2 mL min−1 and UV detection were carried out at 210.0 nm. The greenness profile of the established methods was evaluated and calculated for the first time for CYZ and its toxic impurities through different assessment tools like analytical eco-scale, analytical method volume intensity and greenness profile methods. Validation of the developed methods was carried out in accordance with the guidelines of the International Conference on Harmonization. The suggested methods were accurate, reliable, time and cost-saving. Therefore, they could be used in quantification of CYZ abuse and its toxic impurities in parenteral formulation for routine quality control. The results achieved by applying the suggested methods were statistically analyzed and compared with those given by reported one and no significant differences were obtained regarding both precision and accuracy.

中文翻译：

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对注射用制剂中环嗪及其有毒杂质进行定量的环保验证色谱方法

Cyclizine (CYZ) 滥用通常通过口服或静脉内途径被报道，因为它会产生欣快或幻觉。在成瘾的青少年中伴随滥用 CYZ 会导致危及生命的神经肌肉疾病。因此，开发了两种绿色且经过验证的色谱方法，用于在 1-甲基哌嗪和二苯甲醇（苯甲醇）作为药典规定的 CYZ 杂质存在的情况下测定其肠胃外制剂中的 CYZ（一种止吐药物）。第一种方法是 TLC 光密度测定法，它依赖于使用由乙酸乙酯：异丙醇：氨（9.5：1：0.5，体积比）组成的混合物作为展开系统，TLC 60 F254 硅胶板作为固定相，并检测扫描波段在 210.0 nm 处进行。另一方面，第二种方法是 UPLC，它基于使用由乙醇和 pH 为 5 的酸性水组成的流动相分离 CYZ 及其杂质，通过磷酸的比例（60:40，%v/v）在流速 0.2 mL min-1 和 UV 检测在 210.0 nm 处进行。通过不同的评估工具，如分析生态规模、分析方法体积强度和绿度剖面方法，首次对已建立方法的绿度剖面进行了评估和计算。已开发方法的验证是根据国际协调会议的指导方针进行的。建议的方法准确、可靠、节省时间和成本。所以，它们可用于量化注射用制剂中 CYZ 滥用及其有毒杂质，以进行常规质量控制。对应用建议方法获得的结果进行统计分析，并与报告的结果进行比较，在精密度和准确度方面均未获得显着差异。