{"title":"优化抗糖尿病药物精确生物分析定量的内标选择：关键综述","authors":"Sanket Jadhav, Sandip Auti, Sanjay Sharma","doi":"10.1007/s10337-025-04432-5","DOIUrl":null,"url":null,"abstract":"<div><p>Accurate quantification of antidiabetic drugs within biological matrices is essential for pharmacokinetic, pharmacodynamic, and therapeutic monitoring. Internal standards (ISs) play a pivotal role in ensuring the precision, accuracy, and reproducibility of bioanalytical assays by compensating for matrix effects, instrumental fluctuations, and inconsistencies in sample preparation. This review systematically examined 73 research articles to discern trends in IS selection, extraction techniques, biological fluid distribution, and analytical methodologies employed for quantifying antidiabetic drugs. The study elucidates the rationale behind IS selection, including the utilization of stable isotope-labeled (SIL) compounds, structurally related drugs, and deuterated analogs, which enhance the reliability and robustness of the method. Furthermore, the review underscores the significance of optimizing sample preparation techniques, such as protein precipitation (PP), liquid–liquid extraction (LLE), and solid-phase extraction (SPE), to improve analyte recovery. Advanced chromatographic and mass spectrometric techniques, particularly LC–MS/MS and HPLC/UPLC–MS/MS, provide high sensitivity and specificity along with broad calibration ranges, facilitating precise drug concentration measurements. These findings highlight the necessity for standardized IS selection criteria and refined bioanalytical methodologies to ensure reliable quantification across diverse biological fluids. By addressing existing challenges and proposing best practices, this review contributes to the advancement of bioanalytical research in diabetes management, aiding the optimization of pharmacokinetic studies and therapeutic monitoring of diabetes. The insights presented herein are crucial for enhancing the accuracy of drug quantification, thereby facilitating improved clinical decision-making and the development of more effective antidiabetic therapies.</p><h3>Graphical Abstract</h3>\n<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"88 9","pages":"637 - 657"},"PeriodicalIF":1.3000,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Optimizing Internal Standard Selection for Precise Bioanalytical Quantification of Antidiabetic Drugs: A Critical Review\",\"authors\":\"Sanket Jadhav, Sandip Auti, Sanjay Sharma\",\"doi\":\"10.1007/s10337-025-04432-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Accurate quantification of antidiabetic drugs within biological matrices is essential for pharmacokinetic, pharmacodynamic, and therapeutic monitoring. Internal standards (ISs) play a pivotal role in ensuring the precision, accuracy, and reproducibility of bioanalytical assays by compensating for matrix effects, instrumental fluctuations, and inconsistencies in sample preparation. This review systematically examined 73 research articles to discern trends in IS selection, extraction techniques, biological fluid distribution, and analytical methodologies employed for quantifying antidiabetic drugs. The study elucidates the rationale behind IS selection, including the utilization of stable isotope-labeled (SIL) compounds, structurally related drugs, and deuterated analogs, which enhance the reliability and robustness of the method. Furthermore, the review underscores the significance of optimizing sample preparation techniques, such as protein precipitation (PP), liquid–liquid extraction (LLE), and solid-phase extraction (SPE), to improve analyte recovery. Advanced chromatographic and mass spectrometric techniques, particularly LC–MS/MS and HPLC/UPLC–MS/MS, provide high sensitivity and specificity along with broad calibration ranges, facilitating precise drug concentration measurements. These findings highlight the necessity for standardized IS selection criteria and refined bioanalytical methodologies to ensure reliable quantification across diverse biological fluids. By addressing existing challenges and proposing best practices, this review contributes to the advancement of bioanalytical research in diabetes management, aiding the optimization of pharmacokinetic studies and therapeutic monitoring of diabetes. The insights presented herein are crucial for enhancing the accuracy of drug quantification, thereby facilitating improved clinical decision-making and the development of more effective antidiabetic therapies.</p><h3>Graphical Abstract</h3>\\n<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>\",\"PeriodicalId\":518,\"journal\":{\"name\":\"Chromatographia\",\"volume\":\"88 9\",\"pages\":\"637 - 657\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2025-08-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chromatographia\",\"FirstCategoryId\":\"92\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s10337-025-04432-5\",\"RegionNum\":4,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"BIOCHEMICAL RESEARCH METHODS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chromatographia","FirstCategoryId":"92","ListUrlMain":"https://link.springer.com/article/10.1007/s10337-025-04432-5","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
Optimizing Internal Standard Selection for Precise Bioanalytical Quantification of Antidiabetic Drugs: A Critical Review
Accurate quantification of antidiabetic drugs within biological matrices is essential for pharmacokinetic, pharmacodynamic, and therapeutic monitoring. Internal standards (ISs) play a pivotal role in ensuring the precision, accuracy, and reproducibility of bioanalytical assays by compensating for matrix effects, instrumental fluctuations, and inconsistencies in sample preparation. This review systematically examined 73 research articles to discern trends in IS selection, extraction techniques, biological fluid distribution, and analytical methodologies employed for quantifying antidiabetic drugs. The study elucidates the rationale behind IS selection, including the utilization of stable isotope-labeled (SIL) compounds, structurally related drugs, and deuterated analogs, which enhance the reliability and robustness of the method. Furthermore, the review underscores the significance of optimizing sample preparation techniques, such as protein precipitation (PP), liquid–liquid extraction (LLE), and solid-phase extraction (SPE), to improve analyte recovery. Advanced chromatographic and mass spectrometric techniques, particularly LC–MS/MS and HPLC/UPLC–MS/MS, provide high sensitivity and specificity along with broad calibration ranges, facilitating precise drug concentration measurements. These findings highlight the necessity for standardized IS selection criteria and refined bioanalytical methodologies to ensure reliable quantification across diverse biological fluids. By addressing existing challenges and proposing best practices, this review contributes to the advancement of bioanalytical research in diabetes management, aiding the optimization of pharmacokinetic studies and therapeutic monitoring of diabetes. The insights presented herein are crucial for enhancing the accuracy of drug quantification, thereby facilitating improved clinical decision-making and the development of more effective antidiabetic therapies.
期刊介绍：
Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.
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