Paying attention to issue of environmental protection is an unavoidable duty which encourages analytical society to balance between establishment of new analytical method and preservation of the environment from the harmful chemicals. By adopting this concept, an excellent green high-performance thin-layer chromatography (HPTLC) method was developed for assessment of carbamazepine, the antiepileptic drug, and iminostilbene, the main degradation product and its official impurity. Separation of the structurally related components was completed on HPTLC sheets using a mixture of petroleum ether: acetone (7:3, v/v) as a developing system with UV detection at 230 nm. To assess the greenness profile of the developed method compared with the official high-performance liquid chromatography (HPLC) method, analytical semi-quantitative eco-scale assessment protocol was applied. The suggested method was confirmed to be greener than the official method with regard to solvent consumption and waste emission. The suggested method was successfully applied to determine carbamazepine in the marketed dosage forms with no intrusion of other co-formulated ingredients. Successful application of the developed method was also proved via simultaneous analysis of carbamazepine and iminostilbene in raw materials and human plasma samples in ranges of 0.1–1.4 μg/band and 0.1–1.2 μg/band for carbamazepine and iminostilbene, respectively. As the maximum plasma concentration of the studied medication was within its calibration range, the proposed HPTLC method can be employed for further pharmacokinetic studies. For comprehensive validation of the presented method, ICH figures of merit were evaluated.

中文翻译：

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稳定性指示HPTLC方法的验证和生态规模评估，该方法用于定量分析卡马西平及其降解产物亚氨基二苯乙烯的纯形式，药物制剂和加标人体血浆

注意环境保护是一项不可避免的责任，它鼓励分析社会在建立新的分析方法与保护环境免受有害化学物质之间取得平衡。通过采用此概念，开发了一种出色的绿色高效薄层色谱（HPTLC）方法，用于评估抗癫痫药卡马西平和主要降解产物及其官方杂质亚氨基二苯乙烯。使用石油醚：丙酮（7：3，v / v）的混合物在HPTLC板上完成结构相关组分的分离）作为可在230 nm处进行UV检测的显影系统。为了评估与官方的高效液相色谱（HPLC）方法相比所开发方法的绿色特征，应用了分析半定量生态规模评估方案。在溶剂消耗和废物排放方面，建议的方法被证实比官方方法更环保。所建议的方法已成功地用于测定市售剂型中的卡马西平，而不会干扰其他共同配制的成分。同时分析原料和人体血浆样品中的卡马西平和亚氨基二苯乙烯的含量分别为0.1–1.4μg/ band和0.1–1.2μg/ band的卡马西平和亚氨基二苯乙烯，也证明了该方法的成功应用。由于所研究药物的最大血浆浓度在其校准范围内，因此建议的HPTLC方法可用于进一步的药代动力学研究。为了全面验证所提出的方法，评估了ICH的品质因数。