Department of Pharmaceutical Chemistry, Faculty of Pharmacy, King Abdulaziz University, Jeddah, 21589, P.O. Box 80260, Saudi Arabia.
Pharmaceutical Chemistry Department, College of Pharmacy, Al-Esraa University, Baghdad, Iraq.
Anal Biochem. 2024 Jun;689:115501. doi: 10.1016/j.ab.2024.115501. Epub 2024 Mar 5.
Vonoprazan and amoxicillin are pharmacological combinations that demonstrate synergistic effects in treating Helicobacter pylori (H. pylori), a global public health concern associated with peptic ulcer disease and gastric cancer. Four spectrophotometric methods were developed, including two univariate techniques (Fourier self-deconvolution and ratio difference) and two multivariate chemometric approaches (partial least squares and principal component regression). These methods provide innovative solutions for effectively resolving and accurately quantifying the overlapping spectra of vonoprazan and amoxicillin. The concentration ranges covered were 3-60 μg ml for vonoprazan and 5-140 μg ml for amoxicillin. To assess the environmental sustainability of the methodologies, various measures such as the Green Analytical Procedure Index (GAPI), National Environmental Method Index (NEMI), Analytical GREEnness Calculator, and Analytical Eco-scale, as well as RGB12 and hexagon toll were implemented. The validation of the developed techniques was carried out in compliance with ICH standards. The present study is highly significant because it is the first time that the mixture has been determined using the current approaches. The comparative analysis demonstrated no significant difference in terms of accuracy and precision compared to reference HPLC method (p = 0.05). The established spectrophotometric methods offer a straightforward, rapid, and cost-effective alternative to complex analytical techniques for determining the vonoprazan and amoxicillin mixture. They show potential for routine analysis in research laboratories and pharmaceutical industries.
伏诺拉生和阿莫西林是治疗幽门螺杆菌(H. pylori)的药物组合,幽门螺杆菌是一种全球性的公共卫生问题,与消化性溃疡病和胃癌有关。本文建立了四种分光光度法,包括两种单变量技术(傅里叶自解卷积和比值差)和两种多变量化学计量方法(偏最小二乘法和主成分回归)。这些方法为有效解析和准确量化伏诺拉生和阿莫西林的重叠光谱提供了创新的解决方案。伏诺拉生的浓度范围为 3-60μg/ml,阿莫西林的浓度范围为 5-140μg/ml。为了评估方法的环境可持续性,采用了各种措施,如绿色分析程序指数(GAPI)、国家环境方法指数(NEMI)、分析绿色度计算器、分析生态标度以及 RGB12 和六边形收费等。所建立的方法均符合 ICH 标准进行验证。本研究具有重要意义,因为这是首次使用当前方法对混合物进行测定。与参考 HPLC 方法相比,该方法的准确性和精密度没有显著差异(p=0.05)。所建立的分光光度法为测定伏诺拉生和阿莫西林混合物提供了一种简单、快速且具有成本效益的替代复杂分析技术的方法。这些方法在研究实验室和制药行业具有常规分析的潜力。