Is a deuterated internal standard appropriate for the reliable determination of olmesartan in human plasma?

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• 作者：Edyta Pió ; rkowska¹ ; Jacek Musijowski¹ ; Katarzyna Buś-Kwaśnik ; Piotr J. Rudzki ; ^{p.rudzki@ifarm.eu} ; ^{piotr_rudzki@tlen.pl}
• 关键词：CI ; confidence interval ; EMA ; European Medicines Agency ; FDA ; US Food and Drug Administration ; IS ; internal standard ; LLOQ ; lower limit of quantification ; OLM ; olmesartan ; SIL ; stable isotopically labelled
• 刊名：Journal of Chromatography B
• 出版年：2017
• 出版时间：1 January 2017
• 年：2017
• 卷：1040
• 期：Complete
• 页码：53-59
• 全文大小：572 K
• 卷排序：1040

文摘

First method using deuterated internal standard to quantify olmesartan in plasma. First report on stability of olmesartan-d6 in methanol and 50% methanol solutions. Improved liquid–liquid extraction, method fully validated. Linearity of 5–2500 ng/mL suitable for pharmacokinetic studies after 40 mg dose. Successful clinical application, confirmed by incurred sample reanalysis.