Abdallah Nora A, El-Brashy Amina M, Ibrahim Fawzia A, El-Awady Mohamed I
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, 35516, Egypt.
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Delta University for Science and Technology, International Coastal Road, Gamasa, Mansoura, 11152, Egypt.
BMC Chem. 2023 Mar 15;17(1):19. doi: 10.1186/s13065-023-00929-y.
Cardiovascular disease medications such as aspirin (ASP), statins like atorvastatin (ATR), and blood pressure-lowering drugs including ACE inhibitors like ramipril (RAM) have been included in the World Health Organization (WHO) Essential Medicines List (EML) for many years. Therefore, there is a strong demand to develop a simple, rapid, and sensitive analytical method that can detect and quantitate the ternary mixture of these analytes in pharmaceutical preparations in a short run time. Lately, the analytical community focused on eliminating or reducing hazardous chemicals and solvents usage.
A green, fast, selective, and cost-effective micellar HPLC method was established and validated for the concurrent determination of ternary combination of ASP, ATR, and RAM in the pure form and pharmaceutical preparations. Resolution of the three drugs was achieved by using a monolithic column and a micellar mobile phase consists of 0.3% triethylamine (TEA) in 90: 10 an aqueous solution of 0.12 M sodium dodecyl sulfate (SDS): n-propanol, (v/v). The pH was adjusted to 2.5 using orthophosphoric acid and a flow rate of 1.5 mL/min. was applied. To ensure method reproducibility, Valsartan (VAL) was utilized as an internal standard (IS). The UV detection of the studied drugs was performed at 210 nm. Good linearity for the three drugs was obtained over the concentration ranges of 1.0-200.0 mg/mL, 0.5-200.0 mg/mL, and 5.0-100.0 mg/mL with correlation coefficients of 0.9998,0.9999 and 0.9999 for ASP, ATR, and RAM respectively. The method sensitivity was revealed by the relatively small values of limits of detection (LOD) (0.19, 0.13 and 0.30 mg/mL) and limits of quantitation (LOQ) (0.63, 0.44 and 0.99 mg/mL) for ASP, ATR, and RAM, respectively. The retention times of ASP, ATR and RAM were 1.50, 2.3 and 4.3 min., respectively.
The suggested technique was employed for the analysis of the three drugs in their prepared tablets maintaining the recommended pharmaceutical ratio without any interference from excipients. The method was further extended to content uniformity testing of RAM. The results were validated according to international council for harmonisation (ICH) guidelines.
心血管疾病药物，如阿司匹林（ASP）、阿托伐他汀（ATR）等他汀类药物以及包括雷米普利（RAM）等血管紧张素转换酶抑制剂在内的降压药物，多年来一直被列入世界卫生组织（WHO）基本药物清单（EML）。因此，迫切需要开发一种简单、快速且灵敏的分析方法，能够在短时间内检测和定量药物制剂中这些分析物的三元混合物。最近，分析界致力于消除或减少有害化学品和溶剂的使用。
建立并验证了一种绿色、快速、选择性好且经济高效的胶束高效液相色谱法，用于同时测定纯品和药物制剂中ASP、ATR和RAM的三元组合。使用整体柱和由0.12 M十二烷基硫酸钠（SDS）：正丙醇（90:10，v/v）的水溶液中含0.3%三乙胺（TEA）组成的胶束流动相实现了三种药物的分离。用正磷酸将pH调节至2.5，并采用1.5 mL/min的流速。为确保方法的重现性，使用缬沙坦（VAL）作为内标（IS）。在所研究药物的紫外检测在210 nm处进行。三种药物在1.0 - 200.0 mg/mL、0.5 - 200.0 mg/mL和5.0 - 100.0 mg/mL的浓度范围内具有良好的线性，ASP、ATR和RAM的相关系数分别为0.9998、0.9999和0.9999。该方法的灵敏度通过ASP、ATR和RAM相对较小的检测限（LOD）（分别为0.19、0.13和0.30 mg/mL）和定量限（LOQ）（分别为0.63、0.44和0.99 mg/mL）得以体现。ASP、ATR和RAM的保留时间分别为1.50、2.3和4.3分钟。
所建议的技术用于分析其制备片剂中的三种药物，保持推荐的药物比例，且不受辅料干扰。该方法进一步扩展至RAM的含量均匀度检测。结果根据国际协调理事会（ICH）指南进行了验证。
