Human insulin and its synthetic analogs are considered as life‐saving drugs for people suffering from diabetes mellitus. Next to the therapeutic use, scientific and non‐scientific literature (e.g. bodybuilding forums; antidoping intelligence and investigation reports) indicate that these prohibited substances are used as performance enhancing agents. In the present report, the development and validation of a sensitive analytical strategy is described for the urinary detection of three rapid‐acting insulin analogs (Lispro, Aspart, Glulisine). The method is based on sample purification by the combination of ultrafiltration and immunoaffinity purification and subsequent analysis by nano‐flow liquid chromatography coupled to high resolution mass spectrometry. Next to the results on different validation parameters (LOD: 10 pg/mL; recovery: 25–48%; matrix effect: −3‐(−8) %), data on urinary elimination times, which were obtained in the frame of an administration study with the participation of healthy volunteers, are presented. The determined detection windows (~9 hours) are expected to help to evaluate current routine analytical methods and aim to aid doping authorities to set appropriate target windows for efficient testing.

中文翻译：

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健康人尿液中速效胰岛素类似物的检测。

人胰岛素及其合成类似物被认为是糖尿病患者的救命药物。除了治疗用途之外，科学和非科学文献（例如健美论坛；反兴奋剂情报和调查报告）表明，这些禁用物质被用作性能增强剂。在本报告中，描述了一种灵敏的分析策略的开发和验证，用于三种速效胰岛素类似物（赖脯、门冬、谷赖氨酸）的尿液检测。该方法基于通过超滤和免疫亲和纯化相结合的样品纯化以及随后通过纳流液相色谱与高分辨率质谱联用的分析。在不同验证参数的结果旁边（LOD：10 pg/mL；回收率：25–48%；基质效应：-3-(-8) %)，提供了在健康志愿者参与的给药研究框架内获得的排尿时间数据。确定的检测窗口（约 9 小时）预计将有助于评估当前的常规分析方法，并旨在帮助兴奋剂当局设置适当的目标窗口以进行有效的检测。