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目的:建立高效液相色谱法测定人血浆中亚胺培南浓度,并重点考察亚胺培南血浆样品的稳定性。方法:采用Venusil XBP C18(5μm,4.6mm×250 mm)色谱柱,以10 mmol·L-1磷酸二氢钾-含四丁基溴化铵(0.3 mmol·L-1)甲醇液(96∶4,V∶V)为流动相,调节p H至7.2,柱温为30℃,内标为5-羟基吲哚-3-醋酸,检测波长300 nm。稳定剂0.5mol·L-13-吗啉丙磺酸缓冲液(p H 6.8)-乙二醇-水,体积比2∶1∶1。结果:低、中、高3个浓度提取回收率分别为(89.6±1.7)%,(93.9±2.2)%,(91.4±0.4)%,批内、批间RSD均小于15%;血浆中亚胺培南在0.1~100μg·ml-1浓度范围内线性关系良好(r=0.995~0.996),定量下限为0.1μg·ml-1;不加稳定剂时,含亚胺培南的血浆样品在室温、4℃、-30℃条件下分别可以稳定2,6,8 h,加入稳定剂后分别为6,12,48 h。结论:本试验建立的分析方法线性范围宽,操作简便,准确度高,可用于亚胺培南血药浓度的测定,适用于重症感染患者治疗药物监测。
OBJECTIVE: To establish a method for the determination of imipenem in human plasma by high performance liquid chromatography (HPLC) and to investigate the stability of imipenem plasma samples. METHODS: Venusil XBP C18 column (5 μm, 4.6 mm × 250 mm) was used in this experiment. The column was treated with 10 mmol·L -1 monobasic potassium phosphate (0.3 mmol·L -1) 4, V:V) as the mobile phase, adjusting pH to 7.2, column temperature 30 ℃, internal standard 5-hydroxyindole-3-acetic acid, detection wavelength 300 nm. Stabilizer 0.5 mol·L-13-morpholine propanesulfonic acid buffer (p H 6.8) -ethylene glycol-water in a volume ratio of 2: 1: 1. Results: The recovery rates of low, middle and high concentration were (89.6 ± 1.7)%, (93.9 ± 2.2)% and (91.4 ± 0.4)% respectively. The intra-assay and inter-assay RSD were less than 15% Amine penemide showed a good linearity (r = 0.995-0.996) in the range of 0.1-100μg · ml-1 with a lower limit of quantitation of 0.1μg · ml-1. Imipenem-free plasma samples Room temperature, 4 ℃, -30 ℃ conditions were stable for 2, 6, 8 h, respectively, after adding stabilizers were 6,12,48 h. Conclusion: The analytical method established in this study has a wide linear range, simple and convenient operation and high accuracy. It can be used for the determination of imipenem in plasma and is suitable for the monitoring of therapeutic drugs in patients with severe infections.