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A Highly Sensitive LC-Ms/Ms Method for Determination of Desvenlafaxine in Rabbit Plasma and its Application to Rabbit Pharmacokinetic Study

机译:高灵敏度LC-MS / MS法测定兔血浆中地文拉法辛的含量及其在兔药代动力学研究中的应用

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A highly senstive and rapid LC-MS/MS method has been developed and validated for the estimation of desvenlafaxine in rabbit plasma. The chromatographic separation was performed with 0.2% formic acid: methanol at flow rate of 0.4 mL/min on Symmetry Shield RP18 column with a total run time of 3.0 min. TheMS/MS ion transitions monitored were 263.90? 58.10 for desvenlafaxine and 281.30--> 86.10 for IS (metaprolol). Method validation and pre-clinical sample analysis were performed as per FDA guide lines and the results met the acceptance crieteria. The lower limit of quantification achieved was 0.5 ng/mL and the linearity was observed from 0.5 to 1500 ng/mL. This novel method has been applied to pharmacokinetic study of desvenlafaxine in rabbits.
机译:已经开发了一种高灵敏,快速的LC-MS / MS方法,并已用于评估兔血浆中去甲文拉法辛的有效性。在Symmetry Shield RP18色谱柱上,使用0.2%甲酸:甲醇以0.4 mL / min的流速进行色谱分离,总运行时间为3.0 min。监测的MS / MS离子跃迁为263.90?去甲文拉法辛为58.10,IS(美托洛尔)为281.30-> 86.10。按照FDA指南进行方法验证和临床前样品分析,结果符合验收标准。达到的定量下限为0.5 ng / mL,从0.5到1500 ng / mL观察到线性。该新方法已应用于去甲文拉法辛在兔体内的药代动力学研究。

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