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目的:建立HPLC-UV法测定人尿液中比阿培南的浓度。方法:采用HPLC-UV法,以YMC C18(150 mm×4.6 mm,5μm)为色谱柱,0.1 mol.L-1醋酸钠(醋酸调至pH4.5)∶乙腈=98∶2为流动相,流速为1 mL.min-1,柱温为35℃,检测波长为300 nm,使用1 mol.L-13-N-吗啡啉丙磺酸(MOPS)溶液作为稳定剂。尿液样本经MOPS溶液稀释后直接进样。结果:标准曲线线性范围为0.625~800μg.mL-1,定量下限为0.625μg.mL-1。比阿培南保留时间为3.8 min,批内RSD为0.55%~1.89%,批间RSD为1.50%~3.79%,预处理回收率为95.18%~96.62%,方法回收率在95.35%~103.64%之内。室温放置,反复冻融,进样室中放置,重复进样,-30℃低温条件下放置进行稳定性考察,尿药浓度变化率均<±7%。结论:该方法简单、快速,可满足比阿培南尿药浓度测定及药动学研究。
Objective: To establish a HPLC-UV method for the determination of biapenem in human urine. Methods: The mobile phase consisted of YMC C18 (150 mm × 4.6 mm, 5 μm) column, 0.1 mol·L-1 sodium acetate (adjusted to pH 4.5 with acetic acid): acetonitrile = 98: 2 by HPLC- The flow rate was 1 mL.min-1, the column temperature was 35 ℃, the detection wavelength was 300 nm, and 1 mol·L-13-morpholino propanesulfonic acid (MOPS) solution was used as the stabilizer. Urine samples were diluted directly with MOPS solution. Results: The calibration curve linear range of 0.625 ~ 800μg.mL-1, the lower limit of quantification of 0.625μg.mL-1. The retention time of biapenem was 3.8 min, the intra-assay RSD was 0.55% -1.89%, the inter-assay RSD was 1.50% -3.79%, the pretreatment recovery was 95.18% -96.62%, and the recovery was 95.35% -103.64% within. Placed at room temperature, repeatedly frozen and thawed, placed in the sample chamber, repeated injection, placed at -30 ℃ low temperature stability study, urine drug concentration changes were <± 7%. Conclusion: This method is simple and rapid, which can meet the determination of biapenem concentration and pharmacokinetics.