Sensitive analytical method for Topiramate in human serum by HPLC with pre-column fluorescent derivatization and its application in human pharmacokinetic studies.


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نویسندگان: غلامرضا بهرامی , امیر کیانی , شهلا میرزایی

کلمات کلیدی: Reverse phase chromatography; HPLC; Topiramate; Serum; Bioequivalence study

نشریه: Journal of Chromatography B , , 813 ,

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کد مقاله 10555
عنوان فارسی مقاله
عنوان لاتین مقاله Sensitive analytical method for Topiramate in human serum by HPLC with pre-column fluorescent derivatization and its application in human pharmacokinetic studies.
نوع مقاله مقاله اصیل (پژوهشی، Original)
بالاترین نمایه نامه بین‌المللی ISI
سطح مقاله از مجلات برتر10%(scopus-Q1)
IF 2.176
عنوان نشریه Journal of Chromatography B
نوع نشریه خارجی ایندکس شده
شماره نشریه
دوره 813
تاریخ انتشار شمسی 1383/09/11
تاریخ انتشار میلادی
آدرس لینک مقاله/ همایش در شبکه اینترنت http://www.sciencedirect.com/science/article/pii/S1570023204007664
DOI
آدرس علمی (Affiliation) نویسنده متقاضی Medical Biology Research Center, Medical School, Kermanshah University of Medical Sciences, Kermanshah, Iran

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A sensitive and specific high performance liquid chromatographic method for quantitation of topiramate in human serum was developed using HPLC with fluorescence labeling reagent. Topiramate was extracted from human serum by dichloromethane and derivatized by reaction with 9-fluorenylmethyl chloroformate (FMOC-Cl) in the presence of borate buffer. Analysis was performed on a CN column with sodium phosphate buffer (pH 2.2) containing 1 ml/l triethylamine and methanol (52:48 (v/v)) as mobile phase. Amantadine was used as internal standard. The standard curve was linear over the range 20–5000 ng/ml of topiramate in human serum. The mean intra-day precision was from 10.5% (low concentration) to 1.2% (high concentration) and the within-day precision from 1.5 to 12.5% determined on spiked samples. The accuracy of the method was 96.5–107.5% (intra-day) and 98.4–105% (inter-day). The limit of quantification was 20 ng/ml of serum. This method was used in a bioequivalence study after administration of 2×25 mg topiramate in 24 healthy volunteers. © 2004 Elsevier B.V. All rights reserved.

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نویسنده نفر چندم مقاله نویسنده مسئول
غلامرضا بهرامیاولبلي
امیر کیانیسومخير
شهلا میرزاییدومخير

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