A rapid, sensitive high performance liquid chromatographic method for the determination of meropenem in pharmaceutical dosage form, human serum and urine

A rapid, sensitive high performance liquid chromatographic method for the determination of meropenem in pharmaceutical dosage form, human serum and urine
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DOI:
10.1002/bmc.68
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发表时间:
2001-06-01
影响因子:
1.8
通讯作者:
Aboul-Enein, HY
Aboul-Enein, HY
中科院分区:
医学4区
文献类型:
--
作者:
Özkan, Y;Kücükgüzel, I;Aboul-Enein, HY

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建立了一种简便、精密、快速的高效液相色谱方法,用于测定人血清、尿液和药物剂型中美罗培南的含量。使用 15 mM KH2PO4:乙腈:甲醇 (84:12:4; v/v/v) 的混合物在 LC18 柱上进行色谱分析,用 H3PO4 调节至 pH 2.8。所提出的方法使用反相技术、307.6 nm 处的 UV 监测和头孢吡肟作为内标进行。头孢吡肟和美罗培南的保留时间分别为 5.98 分钟和 7.47 分钟。检测器响应在 50-10,000 ng/mL 的浓度范围内呈线性。该程序的检测限为 22 ng/mL。美罗培南在人血浆中的检出限为108.4 ng/mL,在人尿液中的相应值为179.3 ng/mL。未观察到人血清、尿液和药物制剂中内源性物质的干扰。所提出的方法对于美罗培南浓度的测定足够灵敏,并且可以在接受药物的患者的监测中具有临床应用。版权所有 (C) 2001 John Wiley & Sons, Ltd.
A new, simple, precise and rapid high performance liquid chromatographic method was developed for the determination of meropenem in human serum, urine and pharmaceutical dosage forms. Chromatography was carried out on an LC18 column using a mixture of 15 mM KH2PO4:acetonitrile:methanol (84:12:4; v/v/v), adjusted to pH 2.8 with H3PO4 The proposed method was conducted using a reversed-phase technique, UV monitoring at 307.6 nm and cefepime as an internal standard. The: retention times were 5.98 and 7.47 min for cefepime and meropenem, respectively. The detector response was linear over the concentration range of 50-10,000 ng/mL. The detection Limit of the procedure was found to be 22 ng/mL. The detection limit for meropenem in human plasma was 108.4 ng/mL and the corresponding value in human urine was 179.3 ng/mL. No interference from endogenous substances in human serum, urine and pharmaceutical preparation was observed. The proposed method is sufficiently sensitive for determination of the concentrations of meropenem and may have clinical application for its monitoring in patients receiving the drug. Copyright (C) 2001 John Wiley & Sons, Ltd.