کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5136567 | 1494019 | 2017 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Is a deuterated internal standard appropriate for the reliable determination of olmesartan in human plasma?
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کلمات کلیدی
LLOQEMAOLMFDAEuropean Medicines agency - آژانس دارویی اروپاUS Food and Drug Administration - اداره غذا و داروی ایالات متحدهinternal standard - استاندارد داخلیBioanalytical method validation - اعتبار سنجی روش بی هوازیOlmesartan - اولسمارکتانlower limit of quantification - حد پایین کمیت سنجیSil - سیلPharmacokinetics - فارماکوکینتیکconfidence interval - فاصله اطمینانLiquid chromatography/mass spectrometry - کروماتوگرافی مایع / طیف سنج جرمی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
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چکیده انگلیسی
A right choice of the internal standard is one of the most challenging tasks during bioanalytical method development. Surprisingly, among the HPLC-MS methods for the determination of a cardiovascular drug olmesartan in plasma only structural analogues or similar compounds were used as internal standards. We have tried to answer the question whether the stable isotope labelled (deuterated) internal standard, as recommended by regulatory agencies, can be used for the reliable determination of olmesartan in human plasma. An HPLC-MS method using this standard in a simplified liquid-liquid extraction procedure led to accurate and precise results in the linearity range of 5-2500Â ng/mL. The method is well suited for pharmacokinetic studies following a single 40Â mg oral dose of olmesartan medoxomil in humans. The method was fully validated according to international guidelines and successfully applied in a bioequivalence study in humans. The use of deuterated olmesartan as the internal standard afforded a reliable tool for regulatory bioanalysis that can indirectly contribute to therapy efficacy and improve the safety of patients treated with generic medicines.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Chromatography B - Volume 1040, 1 January 2017, Pages 53-59
Journal: Journal of Chromatography B - Volume 1040, 1 January 2017, Pages 53-59
نویسندگان
Edyta Piórkowska, Jacek Musijowski, Katarzyna BuÅ-KwaÅnik, Piotr J. Rudzki,