Mourad Sara S, Barary Magda A, El-Yazbi Amira F
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Alexandria University, 1 El Khartoum Square, Alexandria, 21521, Egypt.
BMC Chem. 2024 Oct 10;18(1):197. doi: 10.1186/s13065-024-01303-2.
The development of two eco-friendly analytical methods for the simultaneous determination of eight cardiovascular drugs; hydrochlorothiazide (HCT), captopril (CPL), lisinopril (LSP), valsartan (VAL), atorvastatin (ATR), bisoprolol (BSL), amlodipine (AML) and carvedilol (CVL); alongside with the nutraceutical vincamine (VIC) is essential for sustainable pharmaceutical analysis. This study explores the application of Micellar Electro Kinetic Chromatography (MEKC) and High-Performance Liquid Chromatography (HPLC) for this purpose. In MEKC method, the separation was done using fused silica capillary (41.5 cm × 50 µm id) and a back ground electrolyte consisting of 50 mM borate buffer (pH 9) containing 50 mM sodium lauryl sulphate (SLS) and 10% organic modifier (Acetonitrile). In HPLC method, separation was performed on a ZORBAX Extend-C18 (4.6 × 250 mm, 5 µm) column, using a gradient mobile phase consisting of 50 mM phosphate buffer pH 3 and methanol. Both methods attained good linearity (r ≥ 0.9996) with low values of LOD and LOQ. Both methods were successfully applied in the determination of co-administered single, binary and ternary dosage form of the studied drugs. Moreover, application of various combinations of co-administered dosage forms was achieved in rat plasma, confirming the applicability of these methods in different matrices. The use of micellar solutions in MEKC enhances separation efficiency while reducing the need for organic solvents, aligning with green chemistry principles. HPLC methods were optimized using environmentally benign solvents, ensuring reduced toxicity and waste production. The methodologies were evaluated through green, white, and blue metrics to ensure comprehensive sustainability, considering ecological impact, safety, and practical efficiency. These methods were not only cost-effective and time-saving but achieved high efficiency, sensitivity, and reproducibility making them ideal for routine use in pharmaceutical analysis.
开发两种用于同时测定八种心血管药物的环保分析方法至关重要，这八种药物分别是氢氯噻嗪（HCT）、卡托普利（CPL）、赖诺普利（LSP）、缬沙坦（VAL）、阿托伐他汀（ATR）、比索洛尔（BSL）、氨氯地平（AML）和卡维地洛（CVL）；同时测定营养保健品长春胺（VIC）对于可持续药物分析也很重要。本研究探索了胶束电动色谱法（MEKC）和高效液相色谱法（HPLC）在此方面的应用。在MEKC方法中，使用熔融石英毛细管（41.5 cm×50 µm内径）和由50 mM硼酸盐缓冲液（pH 9）组成的背景电解质进行分离，该缓冲液含有50 mM十二烷基硫酸钠（SLS）和10%有机改性剂（乙腈）。在HPLC方法中，在ZORBAX Extend-C18（4.6×250 mm，5 µm）柱上进行分离，使用由50 mM pH 3磷酸盐缓冲液和甲醇组成的梯度流动相。两种方法均具有良好的线性（r≥0.9996），检测限和定量限较低。两种方法均成功应用于所研究药物的联合单剂量、二联和三联剂型的测定。此外，在大鼠血浆中实现了联合剂型的各种组合应用，证实了这些方法在不同基质中的适用性。MEKC中使用胶束溶液提高了分离效率，同时减少了有机溶剂的使用，符合绿色化学原则。HPLC方法使用环境友好型溶剂进行了优化，确保降低毒性和减少废物产生。通过绿色、白色和蓝色指标对这些方法进行了评估，以确保全面的可持续性，同时考虑生态影响、安全性和实际效率。这些方法不仅具有成本效益且节省时间，还具有高效率、高灵敏度和高重现性，使其成为药物分析常规使用的理想方法。
