AbstractA novel, environmentally friendly, and sensitive HPTLC method has been developed and validated for simultaneous quantification of duloxetine (DLX) and tadalafil (TDL) in their pure state, laboratory-prepared mixtures, and spiked human plasma. This method is particularly important for patients dealing with depression and sexual issues, as it allows for the measurement of these co-administered antidepressant and sexual stimulant drugs in biological fluids.

摘要已经开发并验证了一种新颖，环保且灵敏的HPTLC方法，可同时定量度洛西汀（DLX）和他达拉非（TDL）的纯状态，实验室制备的混合物和加标人血浆。这种方法对于处理抑郁症和性问题的患者尤其重要，因为它可以测量生物体液中这些共同施用的抗抑郁药和性兴奋剂药物。

The separation process employed a stationary phase of pre-coated silica gel 60 F254 and a mobile phase consisting of ethyl acetate, acetonitrile, and 33% ammonia (8:1:1, v/v). The optimized mobile phase resulted in well-defined bands for DLX and TDL, with Rf values of 0.3 and 0.8, respectively with dual-wavelength detection at 232 nm for DLX and 222 nm for TDL.

分离过程采用预涂硅胶60 F254的固定相和由乙酸乙酯，乙腈和33%氨（8:1:1，v/v）组成的流动相。优化的流动相为DLX和TDL产生了明确的波段，Rf值分别为0.3和0.8，DLX在232 nm处进行双波长检测，TDL在222 nm处进行双波长检测。

Polynomial regression analysis revealed exceptional linearity for both drugs, with correlation coefficients of 0.9999 over concentration ranges of 10–900 ng/band for DLX and 10-1200 ng/band for TDL. The quantitation limits were 8.2 ng/band for DLX and 8.6 ng/band for TDL, while the detection limits (LOD) were 2.7 ng/band for DLX and 2.8 ng/band for TDL.

多项式回归分析显示，两种药物均具有良好的线性关系，DLX和TDL的浓度范围分别为10-900 ng/带和10-1200 ng/带，相关系数为0.9999。DLX和TDL的定量限分别为8.2 ng/带和8.6 ng/带，而DLX和TDL的检测限（LOD）分别为2.7 ng/带和2.8 ng/带。

The validation of this method followed the guidelines set by the International Council for Harmonization (ICH). Additionally, the suggested method’s greenness was assessed by means of four up-to-date ecological tools, namely the Eco-Scale, the National Environmental Method Index (NEMI), the Green Analytical Procedure Index (GAPI), and the Analytical Greenness metric approach (AGREE).

该方法的验证遵循国际协调理事会（ICH）制定的指南。此外，建议方法的绿色度通过四种最新的生态工具进行评估，即生态规模，国家环境方法指数（NEMI），绿色分析程序指数（GAPI）和分析绿色度度量方法（AGREE）。

The proposed method was also assessed using the Blue Applicability Grade Index (BAGI), a recently developed metric for assessing the practicality (blueness) of procedures..

还使用蓝色适用性等级指数（BAGI）对所提出的方法进行了评估，该指数是最近开发的用于评估程序实用性（蓝色）的指标。。

IntroductionDuloxetine (DLX, Fig. 1), is a chemical compound with the name of 2(+)-(S)-N-methyl-(gamma)-(1-naphthyloxy)-2 thiophen propylamine hydrochloride)1. It significantly inhibits serotonin and norepinephrine reuptake2. It is plausible to infer that DLX functions as a selective reuptake inhibitor at serotonin (5HT) and norepinephrine (NE) carriers, primarily due to its low binding affinity for opioid, histaminergic, dopaminergic, glutamate, cholinergic, and gamma-aminobutyric acid (GABA) reuptake transporters3.

引言度洛西汀（DLX，图1）是一种化合物，名称为2（+）-（S）-N-甲基-（γ）-（1-萘氧基）-2-噻吩丙胺盐酸盐）1。它显着抑制血清素和去甲肾上腺素的再摄取2。可以推断DLX在5-羟色胺（5HT）和去甲肾上腺素（NE）载体上起选择性再摄取抑制剂的作用，主要是由于其对阿片类药物，组胺能，多巴胺能，谷氨酸，胆碱能和γ-氨基丁酸（GABA）再摄取转运蛋白的结合亲和力低3。

DLX has been employed to treat depression and anxiety, offering benefits such as mood enhancement, improved sleep, reduced anxiety, and increased energy, and appetite4. It is utilized in various countries for conditions related to NE and 5HT, including depressive disorders, diabetic neuropathy-induced pain, generalized anxiety disorder (GAD), and fibromyalgia5.

DLX已被用于治疗抑郁症和焦虑症，提供诸如情绪增强，改善睡眠，减少焦虑，增加能量和食欲等益处4。它在各个国家被用于治疗与NE和5HT相关的疾病，包括抑郁症，糖尿病神经病变引起的疼痛，广泛性焦虑症（GAD）和纤维肌痛5。

Compared to other antidepressants, DLX has numerous benefits, including enhanced safety, increased efficacy, tolerance, and minimal undesirable effects. It also has dual inhibitory characteristics and a reduced affinity for neural receptors6.Fig. 1The chemical structures of the studied drugs.Full size imageLiterature concerning DLX encompasses various analytical methods such as spectrophotometry3,7,8,9, spectrofluorimetry6,10,11,12,13, TLC1,2,4,14,15, electrochemical methods16,17,18,19, gas chromatography20, and HPLC21,22,23,24.

。它还具有双重抑制特性，对神经受体的亲和力降低6。图1所研究药物的化学结构。关于DLX的全尺寸图像文献包括各种分析方法，如分光光度法3,7,8,9，荧光分光光度法6,10,11,12,13，TLC1,2,4,14,15，电化学方法16,17,18,19，气相色谱法20和HPLC21,22,23,24。

Tadalafil (TDL) (Fig. 1) is a chemical compound bearing the name of hydro-2-methyl-6-[3,4-(methylene dioxy)phenyl] pyrazino-[1’ ,2’ :1,6] pyrido[3,4-b] indole-1,4-dione)25. TDL, a phosphodiesterase inhibitor, received approval in February 2003 and is utilized for managing erectile disfunction and impotence in men experiencing sexual function issues.

他达拉非（TDL）（图1）是一种化合物，名称为氢-2-甲基-6-[3,4-（亚甲基二氧基）苯基]吡嗪-[1'，2'：1,6]吡啶并[3,4-b]吲哚-1,4-二酮）25。TDL是一种磷酸二酯酶抑制剂，于2003年2月获得批准，用于治疗患有性功能问题的男性的勃起功能障碍和阳痿。

It enhances sexual perform.

它增强了性表现。

Data availability

数据可用性

The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request.

本研究中使用和/或分析的数据集可根据合理要求从通讯作者处获得。

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Download referencesFundingOpen access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).Author informationAuthors and AffiliationsAnalytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, 61519, EgyptSayed M.

下载科学、技术与创新基金管理局（STDF）与埃及知识银行（EKB）合作提供的参考基金开放获取资金。作者信息作者和附属机构Minia大学药学院分析化学系，Minia，61519，埃及Sayed M。

Derayea, Dalia M. Nagy, Al Amir & S. ZaafanDepartment of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Sohag University, Sohag, 82524, EgyptAl Amir S. Zaafan & Mohamed OrabyAuthorsSayed M. DerayeaView author publicationsYou can also search for this author in.

Derayea，Dalia M.Nagy，Al-Amir＆S。索哈格大学药学院药物分析化学系，索哈格，82524，埃及Amir S.Zaafan＆Mohamed OrabyAuthorsSayed M.DerayeaView作者出版物您也可以在中搜索这位作者。

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PubMed Google ScholarContributionsSayed M. Derayea: Conceptualization, Supervision, Writing – review & editing. Al Amir S. Zaafan: Conceptualization, Methodology, Software, Writing – original draft. Dalia M. Nagy: Data curation, Visualization. and Mohamed Oraby: Methodology, Validation, Writing – review & editing.Corresponding authorCorrespondence to.

PubMed谷歌学术贡献评估M.Derayea：概念化，监督，写作-评论和编辑。Al-Amir S.Zaafan：概念化，方法论，软件，写作-原稿。Dalia M.Nagy：数据管理，可视化。和穆罕默德·奥拉比：方法论，验证，写作-评论和编辑。对应作者对应。

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This work was approved by the Committee on the Ethics of Scientific Research, Faculty of Pharmacy, Sohag University, Sohag, Egypt.

这项工作得到了埃及索哈格索哈格大学药学院科学研究伦理委员会的批准。

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Reprints and permissionsAbout this articleCite this articleDerayea, S.M., Zaafan, A.A.S., Nagy, D.M. et al. Novel eco-friendly HPTLC method using dual-wavelength detection for simultaneous quantification of duloxetine and tadalafil with greenness evaluation and application in human plasma.

转载和许可本文引用本文Derayea，S.M.，Zaafan，A.A.S.，Nagy，D.M。等人。新型环保HPTLC方法，使用双波长检测同时定量度洛西汀和他达拉非，并进行绿色评估和在人血浆中的应用。

Sci Rep 14, 23907 (2024). https://doi.org/10.1038/s41598-024-73523-4Download citationReceived: 25 January 2024Accepted: 18 September 2024Published: 13 October 2024DOI: https://doi.org/10.1038/s41598-024-73523-4Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

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KeywordsDuloxetineTadalafilHPTLC-DensitometryDual-wavelengthHuman plasmaGreenness evaluation

关键词多萝西汀他达拉菲HPTLC密度测定双波长人血浆绿色度评价