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首页> 外文期刊>Journal of mass spectrometry: JMS >A fully validated method for the determination of vardenafil in blood using gas chromatography/mass spectrometry
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A fully validated method for the determination of vardenafil in blood using gas chromatography/mass spectrometry

机译：一种完全验证的气相色谱/质谱法测定血液中伐地那非的方法

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Vardenafil (VDN) is one of the three commercially available phosphodiesterase type 5 inhibitors and it is mainly used in the treatment of erectile dysfunction. A sensitive and specific gas chromatography/mass spectrometry (GC/MS) method for the determination of VDN in blood has been developed and validated. Sample preparation included solid-phase extraction and derivatization with N-methyl-N-tert-butyldimethylsilyl-trifluoroacetamide (MTBSTFA) and 1% tert-butyldimethylsilylchloride (TBDMSCl). Protriptyline was used as the internal standard for this assay. Limits of detection and quantification for VDN were 0.70 and 2.00 μg/l, respectively. The calibration curves were linear within the dynamic range 2.00-200.0 μg/l with a correlation coefficient higher than 0.991. Absolute recovery ranged from 88.6% to 95.7% for the analyte of interest at three quality control levels. Intra- and inter-day accuracy was found to be between - 6.1% to 10.8% and - 9.3% to 11.6%, respectively, whereas intra- and inter-day precision was < 7.8% and 9.7%, correspondingly. The proposed method is the first fully validated GC/MS method for the determination of VDN in blood samples and it can be used in routine every day analysis by clinical and forensic laboratories for pharmacokinetic studies, for therapeutic drug level monitoring or for the investigation of related forensic cases. A few blood samples analyzed using the developed method is reported herein to demonstrate the suitability of the method.
机译：伐地那非（VDN）是三种可商购的5型磷酸二酯酶抑制剂之一，主要用于治疗勃起功能障碍。已经开发并验证了用于测定血液中VDN的灵敏，特异性的气相色谱/质谱（GC / MS）方法。样品制备包括固相萃取和用N-甲基-N-叔丁基二甲基甲硅烷基三氟乙酰胺（MTBSTFA）和1％叔丁基二甲基甲硅烷基氯化物（TBDMSC1）衍生化。普罗替林被用作该测定的内标。 VDN的检出限和定量限分别为0.70和2.00μg/ l。校正曲线在2.00-200.0μg/ l的动态范围内呈线性，相关系数高于0.991。在三个质量控制水平下，目标分析物的绝对回收率在88.6％至95.7％之间。日内和日间准确度分别为-6.1％至10.8％和-9.3％至11.6％，而日间和日间准确度分别为<7.8％和9.7％。拟议的方法是第一个经过完全验证的GC / MS方法，用于测定血样中的VDN，可用于临床和法医实验室的日常日常分析中，进行药代动力学研究，治疗药物水平监测或相关药物研究法医案件。本文报道了使用开发的方法分析的一些血液样本，以证明该方法的适用性。

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