A simple, fast and extremely sensitive for estimating Pimavanserin in human (K2EDTA) plasma using ultra high-performance liquid chromatography combined with tandem mass spectrometry (UHPLC–MS/MS) was newly developed and validated. Sample extraction was accomplished using a partition liquid extraction (LLE—liquid–liquid extraction) procedure utilizing extraction solvent, methyl tertiary butyl ether. Separation of the components, chromatography, was done using a C18 chromatographic analytical column employing acetonitrile:methanol: 0.1% formic acid solution (40:40:20 volume by volume) pumped with 0.800 mL/min as the flow rate. For Pimavanserin, the established methodology was linear throughout the calibration curve range from 0.25ng/mL till 50.0 ng/mL. Results of intraday and interday accuracy and precision of Pimavanserin met recent regulatory requirements. This methodology was effectively used to estimate Pimavanserin in vivo human (K2EDTA) plasma concentration for a clinical pharmacokinetic study.

中文翻译：

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一种完全验证的 UHPLC-MS/MS 方法，用于估计人 (K2EDTA) 血浆中匹马万色林的含量及其在临床药代动力学研究中的应用

新开发并验证了一种使用超高效液相色谱结合串联质谱 (UHPLC-MS/MS) 估算人血浆 (K2EDTA) 中匹马万色林的简单、快速和极其灵敏的方法。使用萃取溶剂甲基叔丁基醚的分配液萃取（LLE-液-液萃取）程序完成样品萃取。使用 C18 色谱分析柱进行组分分离，色谱分析柱使用乙腈：甲醇：0.1% 甲酸溶液（体积比为 40:40:20），以 0.800 mL/min 作为流速泵送。对于匹马万色林，已建立的方法在从 0.25 ng/mL 到 50.0 ng/mL 的校准曲线范围内是线性的。Pimavanserin 的日内和日间准确性和精密度结果符合最近的监管要求。该方法有效地用于估计临床药代动力学研究的匹马万色林体内人 (K2EDTA) 血浆浓度。