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Development of a Validated UPLC–MS/MS Method for Simultaneous Estimation of Neratinib and Curcumin in Human Plasma: Application to Greenness Assessment and Routine Quantification
Journal of Chromatographic Science ( IF 1.3 ) Pub Date : 2022-08-22 , DOI: 10.1093/chromsci/bmac067
Alhumaidi B Alabbas 1 , Safar M Alqahtani 1 , Sagar Suman Panda 2 , Majed Alrobaian 3 , Ali Altharawi 1 , Waleed H Almalki 4 , Md Abul Barkat 5 , Rehan A Rub 6 , Mahfoozur Rahman 7 , Shehla Nasar Mir Najib Ullah 8 , Sarwar Beg 6
Affiliation  

A validated ultraperformance liquid chromatography-tandem mass spectrometry (UPLC–MS/MS) method was developed for the first-ever simultaneous analysis of neratinib, curcumin and internal standard (imatinib) using acetonitrile as the liquid–liquid extraction medium. On a BEH C18 (100 mm × 2.1 mm, 1.7 μm) column, the analytes were separated isocratically using acetonitrile (0.1% formic acid):0.002M ammonium acetate. The flow rate was set at 0.5 mL.min−1. The authors utilized multiple reaction monitoring-based transitions for the precursor-to-product ion with m/z 557.099 → 111.928 for neratinib, m/z 369.231 → 176.969 curcumin and m/z 494.526 → 394.141 for imatinib during the study. Validation of the method as per United States Food and Drug Administration requirements for linearity (5–40 ng mL−1), accuracy and precision, stability, matrix effect, etc. were investigated and were observed to be acceptable. Afterward, we evaluated the method for establishing its greenness profile by using two greenness assessment tools and found it green. Overall, a reliable green UPLC–MS/MS method was devised and used to estimate neratinib and curcumin in human plasma simultaneously.

中文翻译:

开发一种经过验证的 UPLC-MS/MS 方法,用于同时估计人血浆中来那替尼和姜黄素:在绿色评估和常规量化中的应用

开发了一种经过验证的超高效液相色谱-串联质谱 (UPLC-MS/MS) 方法,用于首次使用乙腈作为液-液萃取介质同时分析来那替尼、姜黄素和内标 (伊马替尼)。在 BEH C18 (100 mm × 2.1 mm, 1.7 μm) 色谱柱上,使用乙腈(0.1% 甲酸):0.002M 乙酸铵等度分离分析物。流速设置为 0.5 mL.min-1。作者在研究期间对母离子到产物离子使用了基于多反应监测的离子对,来那替尼的 m/z 557.099 → 111.928,姜黄素的 m/z 369.231 → 176.969 和伊马替尼的 m/z 494.526 → 394.141。根据美国食品和药物管理局对线性 (5–40 ng mL-1)、准确度和精密度、稳定性、基质效应等的要求验证方法。被调查并且被观察到是可以接受的。之后,我们使用两个绿色评估工具评估了建立其绿色概况的方法,发现它是绿色的。总体而言,设计了一种可靠的绿色 UPLC-MS/MS 方法,并用于同时估计人血浆中的来那替尼和姜黄素。
更新日期:2022-08-22
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