Nirogi Ramakrishna V S, Kandikere Vishwottam N, Shukla Manoj, Mudigonda Koteshwara, Maurya Santosh, Boosi Ravikumar, Yerramilli Anjaneyulu
Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad 500034, India.
J Pharm Biomed Anal. 2006 Jun 7;41(3):935-42. doi: 10.1016/j.jpba.2006.01.040. Epub 2006 Feb 28.
A simple, sensitive and rapid liquid chromatography/electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) method was developed and validated for the quantification of olanzapine, atypical antipsychotic drug, in human plasma using loratadine as internal standard (IS). Following liquid-liquid extraction, the analytes were separated using an isocratic mobile phase on a reverse phase C18 column and analyzed by MS in the multiple reaction monitoring mode using the respective [M+H]+ ions, m/z 313/256 for olanzapine and m/z 383/337 for the IS. The assay exhibited a linear dynamic range of 0.1-30 ng/mL for olanzapine in human plasma. The lower limit of quantification was 100 pg/mL with a relative standard deviation of less than 10%. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. The average absolute recovery of olanzapine from spiked plasma samples was 85.5+/-1.9%. A run time of 2.0 min for each sample made it possible to analyze more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies.
建立了一种简单、灵敏且快速的液相色谱/电喷雾电离串联质谱（LC-ESI-MS/MS）方法，并进行了验证，用于以氯雷他定为内标（IS）定量测定人血浆中的奥氮平（一种非典型抗精神病药物）。液-液萃取后，使用等度流动相在反相C18柱上分离分析物，并采用多反应监测模式通过质谱分析，分别使用各自的[M+H]+离子，奥氮平为m/z 313/256，内标为m/z 383/337。该测定法在人血浆中奥氮平的线性动态范围为0.1 - 30 ng/mL。定量下限为100 pg/mL，相对标准偏差小于10%。在标准曲线范围内的浓度获得了可接受的精密度和准确度。从加标血浆样品中奥氮平的平均绝对回收率为85.5±1.9%。每个样品的运行时间为2.0分钟，使得每天能够分析400多个人类血浆样品。该经过验证的方法已成功用于分析人血浆样品，以应用于药代动力学、生物利用度或生物等效性研究。
