Parekh Jignesh M, Sanyal Mallika, Yadav Manish, Shrivastav Pranav S
Chemistry Department, Kadi Sarva Vishwavidyalaya, Sarva Vidyalaya Campus, Gujarat, India.
Bioanalysis. 2013 Mar;5(6):669-86. doi: 10.4155/bio.13.25.
Iloperidone is a novel antipsychotic drug with high affinity for serotonin and D(2) dopamine receptors. A sensitive and rapid isotope dilution LC-MS/MS method has been developed for the simultaneous determination of iloperidone and its two major metabolites in human plasma.
The analytes and their deuterated analogs as internal standards were quantitatively extracted from 100-µl human plasma by SPE. The method was validated over the concentration range of 0.01-6 ng/ml for all the analytes. Baseline separation of analytes was possible within 3 min on ACE 5 C8 column. The accuracy and precision (%CV) of the method varied from 96.2 to 105%, and 1.17 to 4.75%, respectively. The extraction recovery was >84%, while the internal standard-normalized matrix factors ranged from 0.97-1.03 for all three analytes.
The developed method was successfully applied to support a bioequivalence study in healthy volunteers.
伊潘立酮是一种新型抗精神病药物，对5-羟色胺和D(2)多巴胺受体具有高亲和力。已开发出一种灵敏且快速的同位素稀释液相色谱-串联质谱法，用于同时测定人血浆中伊潘立酮及其两种主要代谢物。
通过固相萃取从100 μl人血浆中定量提取分析物及其作为内标的氘代类似物。该方法在所有分析物0.01 - 6 ng/ml的浓度范围内得到验证。在ACE 5 C8柱上3分钟内可实现分析物的基线分离。该方法的准确度和精密度（%变异系数）分别在96.2%至105%和1.17%至4.75%之间。提取回收率>84%，而所有三种分析物的内标归一化基质因子在0.97 - 1.03之间。
所开发的方法成功应用于支持健康志愿者的生物等效性研究。
