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智能多元分光光度法同时测定人血浆中两种同时给药的自身免疫性药物;柳氮磺胺吡啶和己酮可可碱的含量。

Smart Multivariate Spectrophotometric Determination of Two Co-Administered Autoimmune Drugs; Sulfasalazine and Pentoxifylline; in Bulk and Spiked Human Plasma.

机构信息

Beni-Suef University, Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, Alshaheed Shehata Ahmad Hegazy St, 62514 Beni-Suef, Egypt.

出版信息

J AOAC Int. 2024 Jan 4;107(1):189-195. doi: 10.1093/jaoacint/qsad097.

DOI:10.1093/jaoacint/qsad097
PMID:37610330
Abstract

BACKGROUND

Sulfasalazine and pentoxifylline are co-prescribed together to treat psoriasis and pemphigus vulgaris. Sulfasalazine is an anti-inflammatory, immunosuppressant, and antibiotic drug, while pentoxifylline is a vasodilator and immunosuppressant. The spectra of the two drugs and plasma suffer from severe overlap.

OBJECTIVE

This work aims to simultaneously determine sulfasalazine and pentoxifylline in their binary mixture and spiked human plasma by the assessment of their UV spectral data.

METHODS

Two model updated chemometric methods were established using principal component regression and partial least-squares regression models. The two models were validated in accordance with the U.S. Food and Drug Administration guidelines for bioanalysis and were applied for the determination of both drugs in synthetic mixtures or spiked human plasma.

RESULTS

Accuracy and precision were within the accepted limits. In addition, three different assessment methods were used to evaluate the environmental greenness of the proposed models.

CONCLUSION

The two updated models are simple, rapid, sensitive, and precise, and could be easily applied in QC laboratories for determination of sulfasalazine and pentoxifylline, without any preliminary separation steps or interference from plasma matrix.

HIGHLIGHTS

Two updated chemometric models called principlal component regression and partial least-squares regression were established for determination of sulfasalazine and pentoxifylline in spiked human plasma using UV spectrophotometric data.

摘要

背景

柳氮磺胺吡啶和己酮可可碱常被联合用于治疗银屑病和寻常性天疱疮。柳氮磺胺吡啶是一种抗炎、免疫抑制和抗生素药物,而己酮可可碱是一种血管扩张剂和免疫抑制剂。这两种药物及其血浆光谱严重重叠。

目的

本工作旨在通过评估其紫外光谱数据,同时测定其在二元混合物和人血浆中添加的柳氮磺胺吡啶和己酮可可碱。

方法

使用主成分回归和偏最小二乘回归模型建立了两种更新的模型。两种模型均按照美国食品和药物管理局的生物分析指南进行了验证,并应用于合成混合物或添加人血浆中两种药物的测定。

结果

准确度和精密度均在可接受范围内。此外,还使用了三种不同的评估方法来评估所提出模型的环境绿色性。

结论

两种更新的模型简单、快速、灵敏、准确,可应用于 QC 实验室,用于测定柳氮磺胺吡啶和己酮可可碱,无需任何预处理分离步骤或不受血浆基质的干扰。

重点

建立了两种更新的化学计量学模型,称为主成分回归和偏最小二乘回归,用于使用紫外分光光度法数据测定人血浆中添加的柳氮磺胺吡啶和己酮可可碱。

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