A simple, rapid, and sensitive LC-MS/MS method for assay of Zolpidem in human plasma has been developed and validated using Zolpidem D6 as internal standard (IS). The extraction of analyte and IS was done using 100 μL of plasma sample by solid phase extraction with Strata X™ 33 μm polymeric sorbent cartridges. The processed plasma samples were separated using mixture of methanol and 5 mM ammonium acetate buffer in 0.1% formic acid (80:20, v/v) as mobile phase on a C18 column at a flow rate of 0.7 mL/min with total run time of 2.0 min. The quantification of the separated components was done in positive ion mode by Multiple Reaction Monitoring (MRM) with mass transitions from m/z 308.0 (parent ion) to m/z 235.0 (product ion) for Zolpidem and from m/z 314.2 (parent ion) to m/z 235.0 (product ion) for the IS. The method was linear in the concentration range of 2.0–200 ng/mL. The recovery was 82.49% and 84.24% for Zolpidem and IS. The inter- and intra-day accuracy and precision were in the range of 94.44 to 103.80% and 2.06 to 8.95%, respectively. The proposed method was successfully applied for pharmacokinetic study of Zolpidem in human volunteers after single oral dose of 10 mg under fasting conditions and incurred sample reanalysis was also performed.

已经开发了一种简单，快速，灵敏的LC-MS / MS方法，用于测定人血浆中的唑吡坦，并使用唑吡坦D6作为内标（IS）进行了验证。使用Strata X™33μm聚合物吸附剂柱通过固相萃取，使用100μL血浆样品进行分析物和IS的萃取。使用甲醇和5 mM乙酸铵缓冲液在0.1％甲酸（80:20，v / v）中的混合物作为流动相在C18色谱柱上以0.7 mL / min的流速和总运行时间分离处理后的血浆样品2.0分钟 通过多反应监测（MRM）以正离子模式对分离出的组分进行定量分析，其中唑吡坦的质量从m / z 308.0（母离子）到m / z 235.0（产物离子），从m / z 314.2（母体）转变离子）到IS的m / z 235.0（产物离子）。该方法在2.0–200 ng / mL的浓度范围内是线性的。唑吡坦和IS的回收率为82.49％和84.24％。日间和日内准确性和精确度分别在94.44至103.80％和2.06至8.95％之间。所建议的方法在禁食条件下单次口服10 mg后，已成功地用于人类志愿者中唑吡坦的药代动力学研究，并进行了样品再分析。