多变量模型更新化学计量学方法测定加标人血浆中吉西他滨和索拉非尼的含量。

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL
Marco M Z Sharkawi, Norhan R Mohamed, Mohammed T El-Saadi, Noha H Amin
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引用次数: 0

摘要

背景:吉西他滨(GEM)是一种嘧啶核苷,已被用作非小细胞肺癌(NSCLC)的一线治疗。索拉非尼(SOR)是一种非选择性多激酶抑制剂,在临床前研究中被用作不同类型癌症的化疗药物,包括NSCLC。GEM和SOR联合给药治疗NSCLC有效且耐受性良好。目的:本工作旨在通过消除重叠光谱和消除血浆基质的干扰,同时测定加标人血浆中的研究药物。方法:利用药物的紫外吸光度建立两个更新的化学计量模型,分别命名为主成分回归(PCR)和偏最小二乘(PLS),用于测定5-25和2-22范围内的GEM和SOR µg/mL。结果:两个更新模型的验证符合美国食品药品监督管理局(FDA)的指导方针,结果令人满意。这两种方法具有所研究药物预测能力高、精密度和准确度高的优点。此外,当对所开发的方法和所报道的方法进行统计比较时,没有获得显著差异,表明所建议的方法具有良好的有效性。结论:这两个更新的模型具有快速、准确、灵敏和成本效益高的优点,可在质量控制实验室中测定GEM和SOR,而无需任何初始分离程序。亮点:开发了两种更新的化学计量方法,即PCR和PLS,用于使用其紫外线吸收数据估计加标人血浆中的GEM和SOR。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Determination of Gemcitabine and Sorafenib in Spiked Human Plasma Using Multivariate Model Update Chemometric Methods.

Background: Gemcitabine (GEM), a pyrimidine nucleoside, has been used as a first-line treatment in non-small-cell lung cancer (NSCLC). Sorafenib (SOR), a nonselective multi-kinase inhibitor, is used as a chemotherapeutic agent in different types of cancers including NSCLC in preclinical studies. Co-administration of GEM and SOR was found to be effective and well-tolerated in the treatment of NSCLC.

Objective: The aim of the present work is to determine the studied drugs in spiked human plasma simultaneously through resolving the overlapping spectra and removing the interference of the plasma matrix.

Method: Two updated chemometric models were developed using UV absorbance of the drugs, which named principal component regression (PCR) and partial least-squares (PLS) for determination of GEM and SOR in the ranges of 5-25 and 2-22 µg/mL, respectively.

Results: Validation of the two updated models has been achieved in accordance with US Food and Drug Administration (FDA) guidelines, and the results were satisfactory. The two methods had the advantages of high predictive ability of the studied drugs with high precision and accuracy. Moreover, there was no significant difference obtained when statistical comparison was done between the developed and reported methods, showing good validity of the suggested methods.

Conclusions: The two updated models have the advantages of being rapid, accurate, sensitive, and cost-effective for the determination of GEM and SOR in quality control laboratories without any need for initial separation procedures.

Highlights: Two updated chemometric methods, PCR and PLS, were developed for the estimation of GEM and SOR in spiked human plasma using their UV absorbance data.

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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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