Mahgoub Hoda, Ragab Marwa A A, Tarek Salma, Maher Hadir M
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Alexandria University, El-Messalah, Alexandria, 21521, Egypt.
BMC Chem. 2024 May 30;18(1):106. doi: 10.1186/s13065-024-01210-6.
Helicobacter pylori has a big sway when peptic ulcers are concerned. For its eradication, different protocols have been approved. Among which, the tripartite therapy protocol which embraces vonoprazan as potassium competitive acid blocker in combination with amoxicillin and metronidazole as antibiotics. An environmentally benign HPLC method is addressed in order to simultaneously determine amoxicillin (AMX), metronidazole (MET) and vonoprazan (VPZ) in bulk powder and combined tablet mixture. Full separation of AMX, MET and VPZ is accomplished using C8 column, and a gradient mobile phase system, composed of methanol and phosphate buffer of a pH value of 5. Fine linearity in the concentration ranges 50-600 µg mL amoxicillin, 50-400 µg mL metronidazole and 10-100 µg mL vonoprazan was denoted by the high correlation coefficient (0.9999). The method accuracy and precision are confirmed upon analyzing AMX, MET and VPZ triple therapy not only in their synthetic mixtures and combined tablet mixtures but also in their combined tablet mixtures in simulated gastric fluid. AMX, MET and VPZ triple therapy could be routinely analyzed in QC labs, in case of being co-formulated, using the presented method. Three different assessment tools were adopted revealing the benign environmental impact of presented method.
幽门螺杆菌在消化性溃疡方面影响重大。为根除该病菌,已批准了不同的治疗方案。其中,三联疗法方案采用沃克(一种钾离子竞争性酸阻滞剂)与阿莫西林和甲硝唑(作为抗生素)联合使用。本文提出了一种环境友好的高效液相色谱法,用于同时测定散装粉末和复方片剂混合物中的阿莫西林(AMX)、甲硝唑(MET)和沃克(VPZ)。使用C8柱和由甲醇与pH值为5的磷酸盐缓冲液组成的梯度流动相系统,可实现AMX、MET和VPZ的完全分离。在阿莫西林浓度范围为50 - 600 μg/mL、甲硝唑浓度范围为50 - 400 μg/mL、沃克浓度范围为10 - 100 μg/mL时,相关系数高达0.9999,表明具有良好的线性关系。通过分析AMX、MET和VPZ三联疗法,不仅在其合成混合物和复方片剂混合物中,而且在模拟胃液中的复方片剂混合物中,都证实了该方法的准确性和精密度。如果AMX、MET和VPZ三联疗法是复方制剂,使用本文提出的方法,可在质量控制实验室进行常规分析。采用了三种不同的评估工具,揭示了本文方法对环境的良性影响。