Journal of Pharmaceutical and Biomedical Analysis Open最新文献

{"title":"Advancements in magnetic MIP-based miniaturized techniques for pharmaceutical and biomedical analysis","authors":"Monireh Bakhshpour-Yücel ,&nbsp;Fatma Yılmaz ,&nbsp;Bilgen Osman ,&nbsp;Adil Denizli","doi":"10.1016/j.jpbao.2026.100102","DOIUrl":"10.1016/j.jpbao.2026.100102","url":null,"abstract":"<div><div>Magnetic materials have become essential for detecting and quantifying various analytes. Advances in technology and molecular recognition have further enhanced the capabilities of these materials, making them crucial components in developing efficient and versatile analytical systems across diverse fields, such as pharmaceuticals, biomedicine, and environmental analysis. One of the most promising innovations in this area is magnetic molecularly imprinted polymers. These materials combine molecular selectivity with the magnetic responsiveness of traditional magnetic materials. This hybrid technology improves analyte recognition and isolation, leading to increased extraction efficiency, speed, and reproducibility. Magnetic molecularly imprinted polymer-based materials allow for easier manipulation and separation of the polymer matrix using an external magnetic field, further enhancing their performance. They are particularly beneficial in applications that require rapid and reliable analyte extraction, facilitating faster on-site analysis and high-throughput screening. This review provides a comprehensive exploration of the principles, design strategies, and applications of magnetic molecularly imprinted polymers, focusing on their use in pharmaceuticals and biomedicine. These innovative materials also play an important role in enhancing the sensitivity and selectivity of sensor systems used in precise analyte detection. Magnetic molecularly imprinted polymers improve analyte extraction efficiency and enable rapid, real-time detection in various analytical applications. It also addresses current challenges and potential future directions for this technology.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"7 ","pages":"Article 100102"},"PeriodicalIF":0.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146037517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and application of an LC-MS/MS method for the determination of 15 antipsychotic and 15 psychotic drugs and metabolites in plasma","authors":"Hao-Zhu Wang ,&nbsp;Masamitsu Maekawa ,&nbsp;Toshihiro Sato ,&nbsp;Yu Sato ,&nbsp;Masaki Kumondai ,&nbsp;Kumiko Fujii ,&nbsp;Yuji Ozeki ,&nbsp;Nariyasu Mano","doi":"10.1016/j.jpbao.2025.100101","DOIUrl":"10.1016/j.jpbao.2025.100101","url":null,"abstract":"<div><div>Antipsychotic drugs play a critical role in the treatment of schizophrenia and related psychiatric disorders. However, their therapeutic effects and adverse reactions vary significantly due to individual metabolic differences and drug-drug interactions (DDIs) as well as genetic polymorphisms in drug-metabolizing enzymes. Although, therapeutic drug monitoring (TDM) is essential for optimizing treatment outcomes, TDM for most antipsychotics remains underutilized in Japan. This study builds upon our previous research, which developed a liquid chromatography–tandem mass spectrometry (LC-MS/MS) method for the simultaneous analysis of 15 antipsychotics, 15 psychiatric drugs and 4 active metabolites. The method was optimized for sensitivity, reproducibility, and accuracy by selected reaction monitoring transitions and optimizing gradient elution parameters. Validation followed FDA bioanalytical guideline, demonstrating excellent linearity (R² &gt; 0.98), intra- and inter-day precision (&lt;15 % RSD for 87 % compounds), and acceptable matrix effects. Stability tests revealed variable degradation patterns among certain analytes, necessitating further refinements. Application of this method to plasma samples from patients with schizophrenia revealed significant inter-individual variability in drug concentrations. Some patients exhibited plasma levels outside the therapeutic range, highlighting the clinical necessity of TDM. By integrating a broader range of psychotropic drugs, this study extends our previous findings and enhances clinical decision-making in psychiatric pharmacotherapy. The developed LC-MS/MS method enables rapid, same-mode quantification suitable for real-time clinical use and provides a valuable tool for assessing the impact of DDIs and optimizing therapeutic strategies in schizophrenia.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"7 ","pages":"Article 100101"},"PeriodicalIF":0.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145839983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enantio-selective analytical method for ergothioneine using chemical tagging coupled with LC-MS/MS and D/L ratio measurements in mushrooms","authors":"Takahiro Takayama ,&nbsp;Miu Nakanishi ,&nbsp;Yuki Makita,&nbsp;Rena Ohnishi,&nbsp;Koichi Inoue","doi":"10.1016/j.jpbao.2026.100103","DOIUrl":"10.1016/j.jpbao.2026.100103","url":null,"abstract":"<div><div>Ergothioneine (EGT), a strong natural antioxidant, is a promising healthcare product owing to its anti-aging activity. EGT is found in various mushrooms, and investigations into its quantity and properties, including chirality, are important from a biological perspective. This study aimed to develop an enantioselective analytical method for EGT and histidine (His) using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The method is developed based on paired enantio-chemical tags, (4-chloro-6-methoxy-1,3,5-triazin-2-yl)-<span>d</span>- and <span>l</span>-leucine, to thiol sites or amine groups. The developed method achieved clear enantioseparation of <span>d</span>- and <span>l</span>‑EGT and <span>d</span>- and <span>l</span>-His with high sensitivity (limits of quantification reached 70–200 fmol). After linearity estimation using a standard reference, the quantification of <span>d</span>- and <span>l</span>-EGT and <span>d</span>- and <span>l</span>-His in 15 mushroom species was performed. The results suggested that the <span>d</span>-EGT and <span>d</span>-His contents were low in all mushroom species tested, whereas sub-milligram-to-milligram-scale <span>l</span>-forms were detected in <em>Pleurotus citrinopileatus</em>, <em>Pleurotus ostreatus</em>, and <em>Pleurotus eryngii var. ferulae</em> species. Although %D was low, the presence of <span>d</span>-EGT in mushroom species was quantified for the first time. Furthermore, docking simulations were performed to investigate the differences in enzymatic interactions between carnitine/organic cation transporter 1 and 3‑mercaptopyruvate sulfurtransferase. The enantiomers of EGT demonstrate different affinities for 3-mercaptopyruvate sulfurtransferase.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"7 ","pages":"Article 100103"},"PeriodicalIF":0.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146187826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantitative analysis of D/L-serine and D/L-proline in serum by isotope-coded derivatization using an original chiral resolution labeling reagent","authors":"Makoto Ozaki ,&nbsp;Yasunari Yamada ,&nbsp;Tsunehisa Hirose ,&nbsp;Motoshi Shimotsuma ,&nbsp;Akari Ikeda ,&nbsp;Takahiro Kawase ,&nbsp;Ai Tsuji ,&nbsp;Shozo Tomonaga ,&nbsp;Miyuki Matsui ,&nbsp;Takefumi Kuranaga ,&nbsp;Hideaki Kakeya","doi":"10.1016/j.jpbao.2025.100099","DOIUrl":"10.1016/j.jpbao.2025.100099","url":null,"abstract":"<div><div>The isotope-coded derivatization method was developed for the accurate quantification of D/<span>L</span>-serine and D/<span>L</span>-proline in serum by liquid chromatography-single quadrupole mass spectrometry (LC<strong>–</strong>MS), using our original chiral resolution labeling reagent labeled with the stable isotope 1-fluoro-2,4-dinitrophenyl-5-<span>D</span>-leucine-¹³C₆-<em>N</em>,<em>N</em>-dimethylethylenediamineamide (¹³C₆-<span>D</span>-FDLDA). These <span>D</span>-amino acids are potential biomarkers for Alzheimer’s disease (AD). The method enables straightforward separation and detection of D/<span>L</span>-serine and D/<span>L</span>-proline using an octadecyl (C₁₈) column after liquid–liquid extraction and derivatization. Moreover, the labeled samples remained stable for at least 1 month when stored at 4°C. The concentrations of <span>D</span>-serine (2.07 ± 0.07 μmol/L) and <span>D</span>-proline (1.50 ± 0.04 μmol/L) in the serum of AD patients were higher than those in non-AD (<span>D</span>-serine: 1.80 ± 0.06 μmol/L; <span>D</span>-proline: 0.43 ± 0.03 μmol/L), consistent with findings from previous studies. Extraction recovery rates for each amino acid were within ±15 %, and no carryover was detected immediately after serum sample analysis. Furthermore, this method enables accurate analysis of D/<span>L</span>-serine and D/<span>L</span>-proline in serum with RSD values below 10 % for intra-day and inter-day reproducibility. This method is promising for enabling early and minimally invasive diagnosis of patients with AD.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"7 ","pages":"Article 100099"},"PeriodicalIF":0.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145685287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Process analytical technologies applied to quality control of emerging alternative protein food products: Challenges and future trends","authors":"Ana Paula Ayub da Costa Barbon ,&nbsp;Irene Marivel Nolasco-Perez ,&nbsp;Sylvio Jr Barbon ,&nbsp;Ademar Domingos Viagem Máquina ,&nbsp;Wen-Hao Su ,&nbsp;Douglas Fernandes Barbin","doi":"10.1016/j.jpbao.2026.100105","DOIUrl":"10.1016/j.jpbao.2026.100105","url":null,"abstract":"<div><div>The escalating global demand for sustainable and health-conscious dietary options has fostered interest in alternative protein food products, ranging from plant-based to cell-based proteins. This review proposes a critical synthesis for integrating Process Analytical Technologies (PAT) into the quality control of these emerging food matrices, focusing on their inherent complexity. The study explores the fundamental technical hurdles posed by the high compositional heterogeneity and the variable structural characteristics of diverse alternative proteins. We discuss various PAT methodologies such as Near-Infrared (NIR) spectroscopy, Raman spectroscopy, and digital imaging, which offer real-time data critical for monitoring product quality. These techniques are characterized by strong spectral interferences from water, lipids, polysaccharides, and novel functional ingredients, which directly affect the robustness and transferability of the model. Consequently, the effective implementation of PAT increasingly depends on advanced chemometrics and data fusion strategies to harmonize heterogeneous data streams. The application of these technologies enables continuous monitoring and control during production, facilitating adherence to evolving regulations and standards. This review highlights the need for advancements in PAT to ensure the consistent quality and safety of alternative protein products, suggesting a future where these technologies are pivotal in the scalability of alternative protein sources.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"7 ","pages":"Article 100105"},"PeriodicalIF":0.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146188356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine learning and optical imaging for pharmaceutical forensic toxicology: A comprehensive review","authors":"Christian H. Pérez-Beltrán ,&nbsp;Ana M. Jiménez-Carvelo ,&nbsp;Eslim S. Sandoval-Sicairos ,&nbsp;Ulises Osuna-Martínez ,&nbsp;Cress L. Santos-Ballardo ,&nbsp;Pablo Y. Carrazco-Ávila ,&nbsp;Edith O. Cuevas-Rodríguez ,&nbsp;Luis Cuadros-Rodríguez","doi":"10.1016/j.jpbao.2026.100104","DOIUrl":"10.1016/j.jpbao.2026.100104","url":null,"abstract":"<div><div>Pharmaceutical forensic toxicology is undergoing a profound transformation driven by the convergence of optical imaging technologies and machine learning methodologies. Traditionally focused on post hoc legal investigations, the field is increasingly expanding toward proactive roles in pharmaceutical quality control, counterfeit drug detection, and public health protection. This review provides a comprehensive and critical overview of the integration of machine learning–based chemometrics with optical imaging techniques in pharmaceutical forensic toxicology. Imaging modalities ranging from grayscale and red, green, blue (RGB) imaging to infrared, Raman, multispectral, and hyperspectral imaging (MSI &amp; HSI) are discussed, with emphasis on their physical principles, data structures, and analytical capabilities. The role of supervised and unsupervised chemometric multivariate models is examined in the context of classification, authentication, and quantitative assessment of pharmaceutical products. Current applications are reviewed across key forensic scenarios, including optical identification of counterfeit and illicit drugs, non-destructive evaluation of confiscated products, retrospective toxicological investigations, and emerging portable artificial intelligence-enabled platforms. Beyond technical performance, this review critically addresses regulatory, ethical, and legal challenges associated with artificial intelligence in forensic environments, highlighting the importance of explainability, traceability, and data governance. Finally, future perspectives are discussed, emphasizing the transition toward integrated forensic ecosystems that combine optical imaging, spectral databases, and interpretable machine learning to support robust, transparent, and legally defensible toxicological decision-making.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"7 ","pages":"Article 100104"},"PeriodicalIF":0.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146187825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigation of the metabolic role of d-amino acid aminotransferase in Arabidopsis thaliana using a column-switching two-dimensional high-performance liquid chromatography system","authors":"Masae Sekine,&nbsp;Masumi Katane,&nbsp;Tetsuya Miyamoto,&nbsp;Yasuaki Saitoh,&nbsp;Hiroshi Homma,&nbsp;Kumiko Sakai-Kato","doi":"10.1016/j.jpbao.2025.100098","DOIUrl":"10.1016/j.jpbao.2025.100098","url":null,"abstract":"<div><div>To investigate the physiological role of <em>Arabidopsis thaliana</em> <span>D-</span>amino acid aminotransferase (AtDAAT), which catalyzes the transformation of <span>D-</span>aspartate (<span><span>D</span></span>-Asp) to <span>D</span>-glutamate (<span><span>D</span>-</span>Glu) and <span><span>D</span></span>-alanine (<span>D-</span>Ala), we analyzed the amounts of various <span>D</span>-amino acids in AtDAAT-deficient and wild-type <em>A. thaliana</em> grown in a medium containing <span><span>D</span></span>-Asp. The amounts of Asp, Glu, Ala, valine (Val), and leucine (Leu) enantiomers in AtDAAT-deficient and wild-type <em>A. thaliana</em> were determined using a highly selective two-dimensional high-performance liquid chromatography (2D-HPLC) system. The 2D-HPLC system comprised reversed-phase and chiral separation columns, and amino acids were derivatized with 4-fluoro-7-nitro-2,1,3-benzoxadiazole for detection. To analyze the various <span>d</span>- and <span>l</span>-amino acids in <em>A. thaliana</em>, the separation conditions reported in our previous study were applied with modifications, and the method was validated. Enantioseparation, linearity, and accuracy were satisfactory for all the amino acid enantiomers studied. The amount of <span><span>D</span></span>-Asp significantly increased in AtDAAT-deficient <em>A. thaliana,</em> whereas the amounts of the <span>D</span>-Glu, <span>D</span>-Ala, and <span>D</span>-Val decreased significantly, indicating the physiological role of AtDAAT in metabolizing exogenous <span><span>D</span></span>-Asp. The amounts of all <span>L-</span>enantiomers were higher in AtDAAT-deficient <em>A. thaliana</em> than in the wild type, indicating the involvement of other amino acid-metabolizing enzymes. Further investigations focusing on the physiological roles of these enzymes in <em>A. thaliana</em> are to be conducted in our laboratory.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"7 ","pages":"Article 100098"},"PeriodicalIF":0.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145685394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Microsampling for antidepressant drug analysis: Current state and perspectives","authors":"Michele Protti ,&nbsp;Roberto Mandrioli ,&nbsp;Laura Mercolini","doi":"10.1016/j.jpbao.2025.100097","DOIUrl":"10.1016/j.jpbao.2025.100097","url":null,"abstract":"<div><div>Microsampling has emerged as a highly promising approach for the quantitative analysis of antidepressant drugs, offering key benefits in terms of minimal invasiveness, reduced blood volume requirements and suitability for decentralised and patient-centric sample collection. Historically, the clinical adoption of therapeutic drug monitoring (TDM) for antidepressants has lagged behind that for other CNS drugs, largely due to perceptions of a wide therapeutic window and moderate toxicity risk. However, growing recognition of pharmacokinetic variability, challenges in polypharmacy and evolving models of personalised medicine, now highlight the critical need for robust and adaptable analytical strategies in this field. Technologies such as dried blood spot (DBS) sampling, volumetric absorptive microsampling (VAMS), capillary- and microfluidic-generated DBS, capillary microsampling (CMS) and novel hybrid/automated platforms have been developed and validated for antidepressant quantification across diverse settings (including clinical, preclinical and forensic applications). This review provides a comprehensive analysis of the principles, methodologies and translational relevance of microsampling for antidepressants, critically summarising evidence from original research papers and key review papers. We explore technical and analytical challenges including matrix effects, haematocrit variability, sample stability and the processes underpinning quantitative bridging to conventional matrices such as plasma and serum. Major recent advances, like operator-independent volumetric devices and workflow automation, are contextualised within the broader push toward remote and home-based monitoring. Clinical validation studies, animal model research and post-mortem investigations are reviewed to illustrate the wide range and adaptability of these technologies. By highlighting both achievements and unresolved barriers, this work demonstrates how microsampling is poised to transform antidepressant TDM, research and future psychiatric pharmacotherapy.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"7 ","pages":"Article 100097"},"PeriodicalIF":0.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145625408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nano-liquid chromatography and electromigration techniques applied to the analysis of dietary supplements. A review","authors":"Chiara Fanali ,&nbsp;Erica Cutè ,&nbsp;Alessandra Gentili ,&nbsp;Michele Pier Luca Guarino ,&nbsp;Salvatore Fanali","doi":"10.1016/j.jpbao.2025.100093","DOIUrl":"10.1016/j.jpbao.2025.100093","url":null,"abstract":"<div><div>Dietary supplements (DSs) or food supplements (FSs) are products widely consumed to support the diet. They could contain amino acids, peptides, proteins, vitamins, minerals, herbs, and compounds of botanical origin. Since they are considered food, they are not subjected to approval by government agencies. Therefore, they are popular because they can be bought without a prescription and are easily available on the internet. The addition of drugs to DSs/FSs is not allowed because it could cause serious damage to health. Therefore, there is a need for analytical methods capable of performing qualitative/quantitative analysis of the declared content and to verify the presence of adulterants. Among the analytical techniques employed, miniaturized techniques have been successfully applied to the analysis of such products. In this review, applications performed with capillary electrophoresis and nano-/capillary-liquid chromatography, and microchip electrophoresis published in the period 2018–2025 (July), are reported and discussed.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100093"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145473491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Miniaturized sample preparation strategies for the determination of N-nitrosamines in pharmaceutical products: A comprehensive review","authors":"Almir Custodio Batista Junior,&nbsp;Yuri Arrates Rocha,&nbsp;Andrea Rodrigues Chaves","doi":"10.1016/j.jpbao.2025.100081","DOIUrl":"10.1016/j.jpbao.2025.100081","url":null,"abstract":"<div><div>N-Nitrosamines (NAs) are classified as potent mutagenic impurities, raising substantial concerns due to their presence in various consumer products, including pharmaceuticals products. The detection of NAs in valsartan-containing medicines in 2018 led regulatory agencies to establish strict guidelines for permissible levels in drug formulations. The standard-gold analytical techniques for NAs determination have been chromatographic techniques (liquid and gas chromatography) coupled with mass spectrometry system, which present higher sensibility and accuracy for target NAs. However, accurate determination of NAs in medicines remains challenging due to their trace-level concentrations and susceptibility to matrix effects, carryover, and contamination of the analytical instrumentation, emphasizing the need for robust sample preparation strategies. Traditional sample preparation methods, although effective, often involve high consumption of solvents, samples, and extraction phases, along with substantial waste generation. In response, miniaturized sample preparation techniques have emerged as sustainable alternatives, offering reduced solvent usage, minimal sample requirements, and lower energy consumption, all while maintaining analytical performance. These green approaches not only align with sustainable analytical practices but also enhance efficiency and environmental compliance in pharmaceutical analysis. This review provides a comprehensive overview of recent advancements in miniaturized sample preparation strategies for the determination of NAs in pharmaceutical products, highlighting their analytical merits and potential for regulatory adoption.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100081"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144704536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}