A rapid analytical method for the quantitation of MB-102 (a fluorescent tracer agent) in human plasma using HPLC with fluorescence detection has been developed and validated. This new plasma sample preparation method, 1/100 direct dilution with phosphate buffered saline instead of typical protein precipitation, improves both robustness and assay efficiency by eliminating the need for sample drying and the need for an internal standard. The validation results show that the new method is robust, specific, precise, accurate, and has a wide linear dynamic range (0.4 ng mL⁻¹ to 400 ng mL⁻¹) with good recovery. The results from 59 clinical study subjects analyzed by both methods yield an excellent correlation with a slope of 1.015 and an R² of 0.994. Sample preparation using direct dilution is easier and faster than the protein precipitation method, and is excellent for determining the MB-102 content in human plasma. The concentration of MB-102 in plasma as a function of time is used to calculate the glomerular filtration rate using a standard pharmacokinetic model.

中文翻译：

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血浆中新型荧光示踪剂MB-102的临床分析和定量†

已经开发并验证了使用HPLC和荧光检测技术定量分析人血浆中MB-102（荧光示踪剂）的快速分析方法。这种新的血浆样品制备方法，用磷酸盐缓冲盐水直接稀释1/100，而不是典型的蛋白质沉淀，通过消除样品干燥和内标的要求，提高了稳健性和测定效率。验证结果表明，该新方法鲁棒，特异，精确，准确，线性动态范围宽（0.4 ng mL ^-1至400 ng mL ^-1），回收率良好。两种方法分析的59个临床研究受试者的结果均具有1.015的斜率和R ²的极好的相关性为0.994。与蛋白质沉淀法相比，使用直接稀释的样品制备方法更容易，更快捷，并且对于测定人血浆中的MB-102含量而言非常出色。使用标准药代动力学模型，将血浆中MB-102的浓度作为时间的函数来计算肾小球滤过率。