Talanta Open ( IF 4.1 ) Pub Date : 2023-03-20 , DOI: 10.1016/j.talo.2023.100207
Abdullah M. Al-Hossaini , Abdullah S. Al-Mutairi , Ibrahim A. Darwish , Ahmed H. Bacheit , Awadh M Ali , Hany W. Darwish
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This study describes, for the first time, the development and validation of a novel microwell-based spectrofluorimetric method assisted with fluorescence plate reader (MWP-SFL) for determination of ruxolitinib (RUX), a drug approved for the treatment of moderate or high-risk myelofibrosis and polycythemiavera, in tablets and urine. The proposed MWP-SFL method was performed in 96-microwell plate and involved the direct measurement of the native fluorescence of RUX by a fluorescence plate reader in aqueous medium at 405 nm after its excitation at 310 nm. The response surface methodology (RSM) was used to establish the optimum procedures and conditions of the analysis. The fluorescence signal was linearly correlated with the RUX concentrations in the range of 0.8 – 250 ng mL−1. The MWP-SFL method limits of detection (LOD) and quantitation (LOQ) were 2.89 and 8.75 ng mL−1, respectively. The accuracy and precision of the method were confirmed as the recovery was 99.66 – 102.29% with relative standard deviation (RSD) values of 0.47 – 1.37%. The MWP-SFL method was successfully applied to the determination of RUX in its pharmaceutical tablets, tablets dissolution testing, tablets content uniformity and urine samples with good precision and accuracy. The proposed MWP-SFL method combined the benefits of the intrinsically high sensitivity of the spectrofluorimetric measurement and the high throughput analytical property of the microwell-based approach. The MWP-SFL method also stands out for its straightforward procedures and use of water as a solvent and little amounts of sample solutions, both of which are consistent with its green chemistry philosophy. These advantages gave the proposed MWP-SFL a high potential value for determination of RUX in quality control and clinical laboratories.
中文翻译:
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新型基于微孔的荧光光谱法辅助荧光酶标仪测定 ruxolitinib:响应面法优化及其在体外药物释放、含量均匀度测试和 u 分析中的应用……
本研究首次描述了一种基于微孔的新型荧光光谱法的开发和验证,该方法辅助荧光板读数器 (MWP-SFL) 用于测定 ruxolitinib (RUX),一种批准用于治疗中度或高度片剂和尿液中存在骨髓纤维化和红细胞增多症的风险。所提出的 MWP-SFL 方法在 96 微孔板中进行,涉及在 310 nm 激发后通过荧光板读数器在 405 nm 的水性介质中直接测量 RUX 的天然荧光。响应曲面法 (RSM) 用于建立最佳分析程序和条件。荧光信号与 RUX 浓度在 0.8 – 250 ng mL −1范围内呈线性相关. MWP-SFL 方法的检测限 (LOD) 和定量限 (LOQ) 分别为 2.89 和 8.75 ng mL -1, 分别。该方法的准确度和精密度得到确认,回收率为 99.66 – 102.29%,相对标准偏差 (RSD) 值为 0.47 – 1.37%。MWP-SFL法成功应用于其药片中RUX的测定、片剂溶出度检测、片剂含量均匀度和尿样,具有良好的精密度和准确度。所提出的 MWP-SFL 方法结合了荧光光谱测量固有的高灵敏度和基于微孔的方法的高通量分析特性的优点。MWP-SFL 方法还因其简单的程序和使用水作为溶剂和少量样品溶液而脱颖而出,这两者都符合其绿色化学理念。