Beni-Suef University, Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, Alshaheed Shehata Ahmed Hegazy St., Beni-Suef 62514, Egypt.
Beni-Suef University, Faculty of Pharmacy, Department of Medicinal Chemistry, Beni-Suef 62514, Egypt.
J AOAC Int. 2023 Nov 2;106(6):1666-1672. doi: 10.1093/jaoacint/qsad062.
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.
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.
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.
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.
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.
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.
吉西他滨（GEM）是一种嘧啶核苷，已被用作非小细胞肺癌（NSCLC）的一线治疗药物。索拉非尼（SOR）是一种非选择性多激酶抑制剂，在临床前研究中已被用作包括 NSCLC 在内的多种癌症的化疗药物。研究发现，吉西他滨和索拉非尼联合用药在治疗 NSCLC 方面具有疗效且耐受性良好。
本研究旨在通过解析重叠光谱并去除血浆基质的干扰，同时测定人血浆中加标的研究药物。
使用药物的紫外吸光度，建立了两种更新的化学计量学模型，分别命名为主成分回归（PCR）和偏最小二乘法（PLS），用于测定 GEM 和 SOR 的范围分别为 5-25 和 2-22μg/mL。
按照美国食品和药物管理局（FDA）的指南验证了这两种更新的模型，结果令人满意。两种方法都具有预测能力高、精密度和准确度高的优点。此外，当对所提出的方法和已报道的方法进行统计学比较时，没有得到显著差异，表明所建议的方法具有良好的有效性。
这两种更新的模型具有快速、准确、灵敏和具有成本效益的优点，可用于质量控制实验室中 GEM 和 SOR 的测定，无需进行初始分离程序。
使用 PCR 和 PLS 两种更新的化学计量学方法，基于其紫外吸光度数据，建立了测定人血浆中加标吉西他滨和索拉非尼的估算方法。
