Background A recent combination of aspirin (ASP) and omeprazole (OMP) has been presented in a fixed dosage form for the treatment of many cardiovascular diseases, particularly in patients with gastric diseases. However, ASP is very sensitive to degradation into salicylic acid (SAL) as its main degradation product. Hence, it is very important to develop methods for the determination of ASP and OMP in the presence of SAL. Objective In this study, UV spectrophotometry assisted by different univariate/multivariate post processing algorithms is presented for quantitative determination of ASP, OMP, and SAL without any prior separation. Methods The univariate/multivariate algorithms include double divisor ratio difference and double divisor mean centering as the univariate approaches while the multivariate methods include principal component regression (PCR) and partial least squares (PLS) models. Validation of the univariate methods was done according to International Conference on Harmonization guidelines, while the multivariate models were validated using an external validation set. Results The univariate algorithms displayed excellent regression and validation capabilities in terms of linearity, accuracy, precision, and selectivity. Regarding PCR and PLS, the number of latent variables were carefully optimized, and the model’s validation criteria displayed excellent recoveries and lower errors of prediction. Conclusion Our findings indicate that the developed methods were comparable to the reported chromatographic methods, but are simpler and have much shorter analysis times. Highlights Overall, this report presents the first spectrophotometric methods applied for determination of possible combinations of ASP, OMP, and SAL, and poses these methods as valuable analytical tools for in-process testing and quality control analysis.

中文翻译：

---

在水杨酸作为降解产物的情况下分光光度法测定阿司匹林和奥美拉唑：不同单变量/多变量后处理算法的比较评估

背景 最近阿司匹林 (ASP) 和奥美拉唑 (OMP) 的组合以固定剂型出现，用于治疗许多心血管疾病，特别是胃病患者。然而，ASP 对降解为水杨酸 (SAL) 作为其主要降解产物非常敏感。因此，开发在 SAL 存在下测定 ASP 和 OMP 的方法非常重要。目的在本研究中，提出了在不同单变量/多变量后处理算法辅助下的紫外分光光度法，用于定量测定 ASP、OMP 和 SAL，而无需任何预先分离。方法单变量/多变量算法包括双除数比差和双除数均值中心作为单变量方法，而多变量方法包括主成分回归（PCR）和偏最小二乘（PLS）模型。单变量方法的验证是根据国际协调会议指南进行的，而多变量模型使用外部验证集进行验证。结果 单变量算法在线性、准确度、精密度和选择性方面表现出出色的回归和验证能力。关于 PCR 和 PLS，潜变量的数量经过精心优化，模型的验证标准显示出出色的回收率和较低的预测误差。结论 我们的研究结果表明，开发的方法与报告的色谱方法相当，但更简单，分析时间更短。要点 总体而言，本报告介绍了第一个用于确定 ASP、OMP 和 SAL 可能组合的分光光度法，并将这些方法作为过程测试和质量控制分析的有价值的分析工具。