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一种同时测定生物流体中文拉法辛和O-去甲基文拉法辛的高效液相色谱法。

A high-performance liquid chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids.

作者信息

Hicks D R, Wolaniuk D, Russell A, Cavanaugh N, Kraml M

机构信息

Drug Metabolism Division, Wyeth-Ayerst Research, Princeton, New Jersey 08540.

出版信息

Ther Drug Monit. 1994 Feb;16(1):100-7. doi: 10.1097/00007691-199402000-00016.

DOI:10.1097/00007691-199402000-00016
PMID:8160247
Abstract

A rapid, accurate, and sensitive high-performance liquid chromatographic (HPLC) method for simultaneous determination of venlafaxine (V) and O-desmethylvenlafaxine (ODV) in plasma and urine has been developed. V and ODV are extracted from plasma using a liquid-liquid extraction procedure, chromatographed on a Supelcosil LC-8DB column, and quantitated by UV detection at 229 nm. Linearity was established over the range 10-500 ng/ml for V and 7.2-720 ng/ml for ODV using 1.0 ml of human, rat, dog, and mouse plasma. For urine, for both analytes, an analytical range 0.1-10.0 micrograms/ml was established. Accuracy of > +/- 10% about the theoretical mean was achieved for all matrices, with intra- and interday coefficients of variation for precision of < 10%. Endogenous components in plasma and/or urine or known metabolites of V do not interfere in the determination of the analytes. For both V and ODV a quantitation limit of 10 ng/ml for plasma was adequate for their estimation over a period of three half-lives, following administration of a pharmacologic dose in man, and the limit of 0.1 microgram/ml, for urine, can monitor excretion of as little as 0.5% of the dose.

摘要

已开发出一种快速、准确且灵敏的高效液相色谱(HPLC)方法,用于同时测定血浆和尿液中的文拉法辛(V)和O-去甲基文拉法辛(ODV)。采用液-液萃取法从血浆中提取V和ODV,在Supelcosil LC-8DB柱上进行色谱分离,并通过在229 nm处的紫外检测进行定量。使用1.0 ml人、大鼠、狗和小鼠血浆,V的线性范围为10 - 500 ng/ml,ODV的线性范围为7.2 - 720 ng/ml。对于尿液,两种分析物的分析范围均为0.1 - 10.0微克/毫升。所有基质的准确度在理论平均值的±10%以内,日内和日间精密度变异系数均<10%。血浆和/或尿液中的内源性成分或V的已知代谢物不干扰分析物的测定。对于V和ODV,血浆中10 ng/ml的定量限足以在人体给予药理剂量后的三个半衰期内对其进行估算,而尿液中0.1微克/毫升的限量能够监测低至剂量0.5%的排泄情况。

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