The aim of the work was to develop a simple, sensitive and accurate liquid chromatography with fluorescence detection (LC-FL) method for the determination of epirubicin in human urine and plasma. Solid phase extraction with HLB cartridges and mixture of dichloromethane:2-propanol:methanol (2:1:1, v/v/v) as the eluent, was used to prepare the samples. The chromatographic analysis was carried out on a Synergi Hydro-RP column with a mobile phase consisting of 40 mM phosphate buffer (pH 4.1) and acetonitrile (69:31, v/v). Epirubicin was monitored at 497 nm and 557 nm for excitation and emission wavelengths, respectively. Validation data confirmed that the limit of detection and limit of quantification was 0.25 ng/mL and 0.5 ng/mL in both matrices. Next, the optimized LC-FL method was applied to determine the level of epirubicin in real samples taken from a 19-year-old patient with metastatic alveolar rhabdomyosarcoma (RMA) to create a drug profile. Plasma and urine samples were collected for 24 h after the end of a 6-hour infusion of epirubicin. The obtained results confirmed that the optimized and validated LC-FL method can be successfully used in drug monitoring therapy, pharmacokinetic and clinical studies. Moreover, the current work is also drawing attention to the relatively high level of epirubicin in the patient urine, which requires compliance with the safety rules in contact with this biological fluid by both medical staff and others, e.g. family members.

中文翻译：

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开发和验证具有荧光检测器的高效液相色谱方法，用于分析人尿和血浆中的表柔比星，并将其应用于药物监测。

这项工作的目的是开发一种简单，灵敏，准确的液相色谱-荧光检测（LC-FL）方法，用于测定人尿和血浆中的表柔比星。使用HLB柱和二氯甲烷：2-丙醇：甲醇（2：1：1，v / v / v）的混合物作为洗脱剂进行固相萃取来制备样品。在具有40 mM磷酸盐缓冲液（pH 4.1）和乙腈（69:31，v / v）组成的流动相的Synergi Hydro-RP色谱柱上进行色谱分析。分别在497 nm和557 nm处监测表柔比星的激发和发射波长。验证数据证实，两种基质的检出限和定量限分别为0.25 ng / mL和0.5 ng / mL。下一个，应用优化的LC-FL方法测定从一名19岁转移性肺泡横纹肌肉瘤（RMA）患者中采集的真实样品中的表柔比星水平，以建立药物档案。表柔比星输注6小时结束后24小时，收集血浆和尿液样本。获得的结果证实，经过优化和验证的LC-FL方法可以成功地用于药物监测治疗，药代动力学和临床研究。此外，当前的工作也引起人们对患者尿液中表柔比星含量较高的关注，这要求医务人员和其他人员（例如家庭成员）均遵守与该生物液体接触的安全规则。表柔比星输注6小时结束后24小时，收集血浆和尿液样本。获得的结果证实，经过优化和验证的LC-FL方法可以成功地用于药物监测治疗，药代动力学和临床研究。此外，当前的工作也引起人们对患者尿液中表柔比星含量较高的关注，这要求医务人员和其他人员（例如家庭成员）均遵守与该生物液体接触的安全规则。表柔比星输注6小时结束后24小时，收集血浆和尿液样本。获得的结果证实，经过优化和验证的LC-FL方法可以成功地用于药物监测治疗，药代动力学和临床研究。此外，当前的工作也引起人们对患者尿液中表柔比星含量较高的关注，这要求医务人员和其他人员（例如家庭成员）均遵守与该生物液体接触的安全规则。