A rapid and accurate spectrofluorimetric method for the determination of pomalidomide was developed and validated based on the measurement of its native fluorescence without the need for any derivatization and separation for the first time. The fluorescence intensity of the drug in acetonitrile solution allowed precise detection at 460 nm after excitation at 296 nm. The calibration curve was linear in the concentration range 31.0-500.0 ng/ml. Limit of detection and limit of quantification were found to be 8.04 and 24.36 ng/ml, respectively. Sensitive results allowed the drug to be detected with good recovery (75.46-109.72%) in human plasma and urine using the developed method. The proposed method was validated in terms of linearity, sensitivity, precision, accuracy, recovery, and stability parameters. Pomalidomide was subjected to degradation under various stress conditions (hydrolytic, oxidative and thermal) to demonstrate that the method was stable, indicating and identifying possible degradation products. In addition, the drug was exposed to electrochemical degradation using the chronoamperometry technique for the first time. Characterization of pomalidomide degradation products obtained because of oxidative degradation and electrochemical degradation was carried out using attenuated total reflection Fourier transform infrared spectroscopy, mass spectrometry and high performance liquid chromatography - mass spectrometry methods and possible structures were proposed.

中文翻译：

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一种简单，快速的荧光光谱法测定加标血浆和尿液中的泊马度胺。在降解研究中的应用。

建立了一种快速准确的荧光光谱法测定波马洛米特，并基于其天然荧光的测量结果进行了验证，而无需首次进行任何衍生化和分离。乙腈溶液中药物的荧光强度允许在296 nm激发后在460 nm精确检测。在31.0-500.0 ng / ml的浓度范围内，校准曲线是线性的。检测限和定量限分别为8.04和24.36 ng / ml。灵敏的结果使得使用开发的方法能够在人血浆和尿液中以良好的回收率检测出该药物（75.46-109.72％）。该方法在线性，灵敏度，精密度，准确度，回收率和稳定性参数方面均得到了验证。在不同的应力条件下（水解，氧化和热）对波马洛米特进行降解，以证明该方法是稳定的，表明并鉴定了可能的降解产物。此外，该药物首次使用计时电流分析技术进行了电化学降解。利用衰减全反射傅立叶变换红外光谱，质谱和高效液相色谱-质谱方法对由于氧化降解和电化学降解而获得的波马度胺降解产物进行了表征，并提出了可能的结构。首次使用计时电流分析技术将药物暴露于电化学降解。利用衰减全反射傅立叶变换红外光谱，质谱和高效液相色谱-质谱方法对由于氧化降解和电化学降解而获得的波马度胺降解产物进行了表征，并提出了可能的结构。首次使用计时电流分析技术将药物暴露于电化学降解。利用衰减全反射傅立叶变换红外光谱，质谱和高效液相色谱-质谱方法对由于氧化降解和电化学降解而获得的波马度胺降解产物进行了表征，并提出了可能的结构。