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Multivariate Model Update Chemometric Methods for Determination of Prednisolone and Esomeprazole in Spiked Human Plasma: A Comparative Study
Journal of AOAC INTERNATIONAL ( IF 1.6 ) Pub Date : 2021-09-03 , DOI: 10.1093/jaoacint/qsab114
Nehal F Farid 1 , Maimana A Magdy 1 , Basma H Anwar 1 , Nessreen S Abdelhamid 1
Affiliation  

Background Prednisolone (PRD) is an immunosuppressant and anti-inflammatory drug, although it may cause peptic ulcers as a side effect. Esomeprazole (ESO) is used for the treatment of peptic ulcers, therefore the two drugs are co-administered in cases of organ transplantation and autoimmune diseases. Objective This work aims to determine the two drugs simultaneously, in bulk, and in spiked human plasma by eliminating the overlap of their spectra and the interference of the plasma matrix. Methods Two simple and effective updated chemometric models—principal component analysis (PCA) and partial least squares (PLS)—were established using UV spectrophotometric data. Results The two updated models have been validated according to the U.S. Food and Drug Administration guidelines with acceptable results. The results were statistically compared with those of the reported methods, where no significant difference was found, indicating the validity of the developed methods. The two updated models have been successfully applied for prediction of the proposed drugs with good accuracy and precision. Conclusion The two updated models are simple, rapid, sensitive, and precise and could be easily applied in quality control laboratories for determination of PRD and ESO, without any preliminary separation steps or interference from plasma matrixes. Highlights Two model updated chemometric models, PCA and PLS, were established for determination of PRD and ESO in spiked human plasma using UV spectrophotometric data.

中文翻译:

测定加标人血浆中强的松龙和埃索美拉唑的多变量模型更新化学计量学方法:一项比较研究

背景强的松龙 (PRD) 是一种免疫抑制剂和抗炎药,尽管它可能会引起消化性溃疡的副作用。埃索美拉唑 (ESO) 用于治疗消化性溃疡,因此这两种药物在器官移植和自身免疫性疾病的情况下共同给药。目的 本工作旨在通过消除两种药物光谱的重叠和血浆基质的干扰,同时、批量和在人血浆中测定两种药物。方法 使用紫外分光光度法数据建立了两个简单有效的更新化学计量模型——主成分分析 (PCA) 和偏最小二乘法 (PLS)。结果 两个更新的模型已根据美国食品和药物管理局指南进行了验证,结果可接受。结果与报告方法的结果进行了统计学比较,没有发现显着差异,表明所开发方法的有效性。这两个更新的模型已成功应用于预测所提出的药物,具有良好的准确性和精度。结论 两个更新的模型简单、快速、灵敏、精确,可轻松应用于质量控制实验室测定 PRD 和 ESO,无需任何初步分离步骤或血浆基质的干扰。要点 建立了两个模型更新的化学计量模型,PCA 和 PLS,用于使用紫外分光光度数据测定加标人血浆中的 PRD 和 ESO。这两个更新的模型已成功应用于预测所提出的药物,具有良好的准确性和精度。结论 两个更新的模型简单、快速、灵敏、精确,可轻松应用于质量控制实验室测定 PRD 和 ESO,无需任何初步分离步骤或血浆基质的干扰。要点 建立了两个模型更新的化学计量模型,PCA 和 PLS,用于使用紫外分光光度数据测定加标人血浆中的 PRD 和 ESO。这两个更新的模型已成功应用于预测所提出的药物,具有良好的准确性和精度。结论 两个更新的模型简单、快速、灵敏、精确,可轻松应用于质量控制实验室测定 PRD 和 ESO,无需任何初步分离步骤或血浆基质的干扰。要点 建立了两个模型更新的化学计量模型,PCA 和 PLS,用于使用紫外分光光度数据测定加标人血浆中的 PRD 和 ESO。无需任何初步分离步骤或来自血浆基质的干扰。要点 建立了两个模型更新的化学计量模型,PCA 和 PLS,用于使用紫外分光光度数据测定加标人血浆中的 PRD 和 ESO。无需任何初步分离步骤或来自血浆基质的干扰。要点 建立了两个模型更新的化学计量模型,PCA 和 PLS,用于使用紫外分光光度数据测定加标人血浆中的 PRD 和 ESO。
更新日期:2021-09-03
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