{"title":"超高效液相色谱-四极杆飞行时间质谱联用超灵敏定量血浆中硫酸吲哚酚和3-羧基-4-甲基-5-丙基-2-呋喃丙酸","authors":"Jun Negami, Yosuke Suzuki, Haruki Sato, Daiki Toyama, Ayako Oda, Ryota Tanaka, Hiroyuki Ono, Tadasuke Ando, Toshitaka Shin, Hiroki Itoh, Keiko Ohno","doi":"10.1002/jcla.70077","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Uremic toxins such as indoxyl sulfate and 3-carboxy-4-methyl-5-propyl-2-furanpropanoic acid (CMPF) are accumulated in patients with chronic kidney disease (CKD). Recent studies have shown that the accumulation of indoxyl sulfate and CMPF alters the activity of organic anion transporting polypeptide (OATP) 1B and cytochrome P450 (CYP) 3A, respectively. We established and validated a novel ultra-sensitive method for simultaneous quantification of indoxyl sulfate and CMPF using ultra-performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS).</p>\n </section>\n \n <section>\n \n <h3> Method</h3>\n \n <p>In this method, plasma samples were prepared by solid phase extraction, then analyzed by UPLC-QTOF/MS to measure concentrations of analytes. Using only 5 μL of human plasma per assay, the calibration range was 0.05–200 μg/mL and the lower limit of quantification was 0.05 μg/mL for both indoxyl sulfate and CMPF.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>This assay met the acceptance criteria of the U.S. Food and Drug Administration bioanalytical method validation guidance. The clinical applicability of this assay was evaluated by measuring plasma concentrations in healthy volunteers and CKD patients. All measured concentrations were within the calibration range.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Our novel assay may contribute to the estimation of variation of OATP1B and CYP3A activities in patients, including those with CKD.</p>\n </section>\n </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"39 16","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.70077","citationCount":"0","resultStr":"{\"title\":\"Ultra-Sensitive Quantification of Indoxyl Sulfate and 3-Carboxy-4-Methyl-5-Propyl-2-Furanpropanoic Acid in Plasma Using Ultra-Performance Liquid Chromatography Coupled to Quadrupole Time-of-Flight Mass Spectrometry\",\"authors\":\"Jun Negami, Yosuke Suzuki, Haruki Sato, Daiki Toyama, Ayako Oda, Ryota Tanaka, Hiroyuki Ono, Tadasuke Ando, Toshitaka Shin, Hiroki Itoh, Keiko Ohno\",\"doi\":\"10.1002/jcla.70077\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Uremic toxins such as indoxyl sulfate and 3-carboxy-4-methyl-5-propyl-2-furanpropanoic acid (CMPF) are accumulated in patients with chronic kidney disease (CKD). Recent studies have shown that the accumulation of indoxyl sulfate and CMPF alters the activity of organic anion transporting polypeptide (OATP) 1B and cytochrome P450 (CYP) 3A, respectively. We established and validated a novel ultra-sensitive method for simultaneous quantification of indoxyl sulfate and CMPF using ultra-performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Method</h3>\\n \\n <p>In this method, plasma samples were prepared by solid phase extraction, then analyzed by UPLC-QTOF/MS to measure concentrations of analytes. Using only 5 μL of human plasma per assay, the calibration range was 0.05–200 μg/mL and the lower limit of quantification was 0.05 μg/mL for both indoxyl sulfate and CMPF.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>This assay met the acceptance criteria of the U.S. Food and Drug Administration bioanalytical method validation guidance. The clinical applicability of this assay was evaluated by measuring plasma concentrations in healthy volunteers and CKD patients. All measured concentrations were within the calibration range.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>Our novel assay may contribute to the estimation of variation of OATP1B and CYP3A activities in patients, including those with CKD.</p>\\n </section>\\n </div>\",\"PeriodicalId\":15509,\"journal\":{\"name\":\"Journal of Clinical Laboratory Analysis\",\"volume\":\"39 16\",\"pages\":\"\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-07-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.70077\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Laboratory Analysis\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/jcla.70077\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Laboratory Analysis","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/jcla.70077","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Ultra-Sensitive Quantification of Indoxyl Sulfate and 3-Carboxy-4-Methyl-5-Propyl-2-Furanpropanoic Acid in Plasma Using Ultra-Performance Liquid Chromatography Coupled to Quadrupole Time-of-Flight Mass Spectrometry
Background
Uremic toxins such as indoxyl sulfate and 3-carboxy-4-methyl-5-propyl-2-furanpropanoic acid (CMPF) are accumulated in patients with chronic kidney disease (CKD). Recent studies have shown that the accumulation of indoxyl sulfate and CMPF alters the activity of organic anion transporting polypeptide (OATP) 1B and cytochrome P450 (CYP) 3A, respectively. We established and validated a novel ultra-sensitive method for simultaneous quantification of indoxyl sulfate and CMPF using ultra-performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS).
Method
In this method, plasma samples were prepared by solid phase extraction, then analyzed by UPLC-QTOF/MS to measure concentrations of analytes. Using only 5 μL of human plasma per assay, the calibration range was 0.05–200 μg/mL and the lower limit of quantification was 0.05 μg/mL for both indoxyl sulfate and CMPF.
Results
This assay met the acceptance criteria of the U.S. Food and Drug Administration bioanalytical method validation guidance. The clinical applicability of this assay was evaluated by measuring plasma concentrations in healthy volunteers and CKD patients. All measured concentrations were within the calibration range.
Conclusion
Our novel assay may contribute to the estimation of variation of OATP1B and CYP3A activities in patients, including those with CKD.
期刊介绍：
Journal of Clinical Laboratory Analysis publishes original articles on newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing. This includes reports from the following fields: immunochemistry and toxicology, hematology and hematopathology, immunopathology, molecular diagnostics, microbiology, genetic testing, immunohematology, and clinical chemistry.
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