Tantawy Mahmoud A, Weshahy Soheir A, Wadie Mina, Rezk Mamdouh R
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Biomed Chromatogr. 2020 Aug;34(8):e4850. doi: 10.1002/bmc.4850. Epub 2020 Jun 5.
A promising combination of tamsulosin HCl and tadalafil has recently been introduced for treating two prevalent and associated urological disorders: benign prostate hyperplasia and erectile dysfunction. Novel HPTLC methods were designed and validated for assaying the cited drugs in their challenging combined formulation. Separation was achieved using HPTLC silica gel 60 F plates as a stationary phase with a densitometric measurement at 280 nm. The proposed methods with two different chromatographic systems were successfully applied: a conventional mixture (method I) of ethyl acetate-toluene-methanol-ammonia (5:3:2:0.5, by volume) and a greener one (method II) with ethyl acetate-ethanol-ammonia (8:2:0.1, by volume). The two methods were evaluated through a comparative study in terms of selectivity, tailing factor, developing time and concentration ranges. The greenness profile for each method was then appraised with several green guides, namely GlaxoSmithKline solvent sustainability guide, Environmental, Health and Safety (EHS) tool, National Environmental Method Index (NEMI) and Eco-scale. Moreover, method specificity and peak homogeneity were evaluated by peak purity assessment using the winCATS software spectral correlation tool. The methods have potential for being simple, fast, economic and selective, and the greener one could be a good option for sustainable analysis of the drugs.
最近引入了一种有前景的盐酸坦索罗辛和他达拉非的组合，用于治疗两种常见且相关的泌尿系统疾病：良性前列腺增生和勃起功能障碍。设计并验证了新型高效薄层色谱（HPTLC）方法，用于测定具有挑战性的联合制剂中的上述药物。使用HPTLC硅胶60 F板作为固定相，在280 nm处进行密度测定以实现分离。成功应用了具有两种不同色谱系统的所提出方法：一种是常规混合物（方法I），由乙酸乙酯 - 甲苯 - 甲醇 - 氨（体积比为5:3:2:0.5）组成，另一种更环保的（方法II）由乙酸乙酯 - 乙醇 - 氨（体积比为8:2:0.1）组成。通过比较研究从选择性、拖尾因子、展开时间和浓度范围方面对这两种方法进行了评估。然后用几种绿色指南对每种方法的绿色度进行评估，即葛兰素史克溶剂可持续性指南、环境、健康与安全（EHS）工具、国家环境方法指数（NEMI）和生态尺度。此外，使用winCATS软件光谱相关工具通过峰纯度评估来评估方法的特异性和峰同质性。这些方法具有简单、快速、经济和选择性的潜力，并且更环保的方法可能是药物可持续分析的一个好选择。
