A. Märtson, K. V. Hateren, G. Bosch, T. Werf, D. Touw, J. Alffenaar
{"title":"液相色谱-串联质谱法测定人血清中更昔洛韦和阿昔洛韦的含量","authors":"A. Märtson, K. V. Hateren, G. Bosch, T. Werf, D. Touw, J. Alffenaar","doi":"10.17145/JAB.18.022","DOIUrl":null,"url":null,"abstract":"Abstract OBJECTIVES: Currently there is no data about a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay including ganciclovir and acyclovir using stable-isotopically labeled internal standards. METHODS: LC-MS/MS assay for measurement of ganciclovir and acyclovir using deuterated standards: ganciclovir-[2H5] and acyclovir-[2H4] was developed. The selectivity and sensitivity, linearity, accuracy and precision, recovery, matrix effect, stability, total process efficiency, carry-over and dilution integrity were validated based on EMA and FDA guidelines. RESULTS: The retention time for ganciclovir was 1.1 min and for acyclovir 1.35 min. Calibration curves were linear over a range of 0.1 to 20 mg/L and the correlation coefficient (R2) was 0.99912 for ganciclovir and 0.99945 for acyclovir. The calculated accuracy was –2.0% to 3.1% for ganciclovir and –1.0% to 6.4% for acyclovir. Within-day precision ranged from 1.8% to 6.6% for ganciclovir and 1.6 % to 6.5% for acyclovir and between-day precision 0% to 9.6% for ganciclovir and 0% to 7.9% for acyclovir. CONCLUSIONS: A rapid and validated LC-MS/MS method was developed for measurement of ganciclovir and acyclovir in human serum which can be used in routine patient care and clinical research.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"53 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2018-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"6","resultStr":"{\"title\":\"Determination of Ganciclovir and Acyclovir in Human Serum using Liquid Chromatography-Tandem Mass Spectrometry\",\"authors\":\"A. Märtson, K. V. Hateren, G. Bosch, T. Werf, D. Touw, J. Alffenaar\",\"doi\":\"10.17145/JAB.18.022\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract OBJECTIVES: Currently there is no data about a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay including ganciclovir and acyclovir using stable-isotopically labeled internal standards. METHODS: LC-MS/MS assay for measurement of ganciclovir and acyclovir using deuterated standards: ganciclovir-[2H5] and acyclovir-[2H4] was developed. The selectivity and sensitivity, linearity, accuracy and precision, recovery, matrix effect, stability, total process efficiency, carry-over and dilution integrity were validated based on EMA and FDA guidelines. RESULTS: The retention time for ganciclovir was 1.1 min and for acyclovir 1.35 min. Calibration curves were linear over a range of 0.1 to 20 mg/L and the correlation coefficient (R2) was 0.99912 for ganciclovir and 0.99945 for acyclovir. The calculated accuracy was –2.0% to 3.1% for ganciclovir and –1.0% to 6.4% for acyclovir. Within-day precision ranged from 1.8% to 6.6% for ganciclovir and 1.6 % to 6.5% for acyclovir and between-day precision 0% to 9.6% for ganciclovir and 0% to 7.9% for acyclovir. CONCLUSIONS: A rapid and validated LC-MS/MS method was developed for measurement of ganciclovir and acyclovir in human serum which can be used in routine patient care and clinical research.\",\"PeriodicalId\":15014,\"journal\":{\"name\":\"Journal of Applied Bioanalysis\",\"volume\":\"53 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2018-12-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Applied Bioanalysis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17145/JAB.18.022\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Applied Bioanalysis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17145/JAB.18.022","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Determination of Ganciclovir and Acyclovir in Human Serum using Liquid Chromatography-Tandem Mass Spectrometry
Abstract OBJECTIVES: Currently there is no data about a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay including ganciclovir and acyclovir using stable-isotopically labeled internal standards. METHODS: LC-MS/MS assay for measurement of ganciclovir and acyclovir using deuterated standards: ganciclovir-[2H5] and acyclovir-[2H4] was developed. The selectivity and sensitivity, linearity, accuracy and precision, recovery, matrix effect, stability, total process efficiency, carry-over and dilution integrity were validated based on EMA and FDA guidelines. RESULTS: The retention time for ganciclovir was 1.1 min and for acyclovir 1.35 min. Calibration curves were linear over a range of 0.1 to 20 mg/L and the correlation coefficient (R2) was 0.99912 for ganciclovir and 0.99945 for acyclovir. The calculated accuracy was –2.0% to 3.1% for ganciclovir and –1.0% to 6.4% for acyclovir. Within-day precision ranged from 1.8% to 6.6% for ganciclovir and 1.6 % to 6.5% for acyclovir and between-day precision 0% to 9.6% for ganciclovir and 0% to 7.9% for acyclovir. CONCLUSIONS: A rapid and validated LC-MS/MS method was developed for measurement of ganciclovir and acyclovir in human serum which can be used in routine patient care and clinical research.