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LC/MS/MS Method for the Determination of Oxycodone in Human Plasma

机译:LC / MS / MS法测定人血浆中羟考酮的方法

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The specificity of the method for oxycodone and oxycodone-d_(3) was demonstrated for samples from six independent matrix sources. The mean internal standard-normalized matrix factor for QC-Low samples from six independent matrix sources was 1.00. Dilution integrity was demonstrated for dilution factors of 2 and 20. Reinjection reproducibility was demonstrated after storage in the autosampler for 24 h. There was no interference from the following over-the-counter drugs: acetaminophen, ibuprofen, caffeine, chlorpheniramine maleate, naproxen, and pseudoephedrine. Stability was demonstrated for the following conditions: whole-blood (2 h), short-term (24 h, room temperature), post-preparative (24 h, 2-8 deg C), autosampler stability using a freshly prepared curve (24 h, 10 deg C), freeze/thaw (5 cycles), and long-term storage (6 months). In all cases, results met acceptance criteria as per the 2001 Bioanalytical Guidance Document and current industry best practices; the method was determined to be suitable for the intended application.
机译:对来自六个独立基质来源的样品进行了对羟考酮和羟考酮-D_(3)的方法的特异性。六个独立矩阵源的QC低样的平均内标标准化矩阵因子为1.00。稀释完整性被证明为2和20的稀释因子。在自动进样器中储存24小时后,证明了再注入的重塑性。以下柜台过度药物没有干扰:对乙酰氨基酚,布洛芬,咖啡因,氯苯那三明民,萘普生和伪麻黄碱。在以下条件下证明了稳定性:全血(2小时),短期(24小时,室温),制备后(24小时,2-8℃),使用新鲜制备的曲线进行自动进样器稳定性(24 H,10℃),冷冻/解冻(5个循环)和长期储存(6个月)。在所有情况下,结果按照2001年生物分析指导文件和现行行业最佳实践满足验收标准;确定该方法适用于预期的应用。

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