Salman Baher I, Batakoushy Hany A, Saraya Roshdy E, Abdel-Aal Mohamed A A, Ibrahim Adel Ehab, Hassan Yasser F, Hassan Ahmed I, El-Shoura Ehab A M
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University Assiut Branch Assiut 71524 Egypt
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Menoufia University Shebin Elkom 32511 Egypt.
RSC Adv. 2024 Apr 2;14(15):10445-10451. doi: 10.1039/d4ra01198h. eCollection 2024 Mar 26.
Avapritinib (AVA) is the first medication authorized by the US-FDA in 2020 for the management of gastrointestinal stromal tumours (GISTs) that can't be treated by surgery. Cancer is among the most common causes of death worldwide and is the second most common cause of death after cardiovascular disease. Therefore, a quick, easy, sensitive, and straightforward fluorimetric approach was used to analyse AVA in pharmaceutical materials and blood plasma (pharmacokinetic). The suggested technique relies on 2% sodium dodecyl sulphate (SDS, pH 4) micellar system augmentation of the fluorescence of the tested drug. The technique demonstrated high relative fluorescence intensity (RFI) at 430 nm after excitation at 340 nm. Concentrations ranging from 20.0-400.0 ng mL with a limit of quantitation of 9.47 ng mL were used to obtain luminescence data for the studied medicine. In addition, the quantum yield of the AVA fluorescence was increased with the gradual addition of a surfactant at a concentration above its critical micellar level. This knowledge has been exploited to enhance the effectiveness of a spectrofluorometric technique for the estimation of AVA in human plasma (98.95 ± 1.22%) and uniformity tests with greenness assessments. The conditions for enhanced fluorescence were optimized and fully validated using US-FDA and International Conference on Harmonization (ICH) rules. This innovative strategy was expanded for AVA stability research in human plasma across various circumstances. This approach is an eco-friendly solution compared to traditional testing methods that use hazardous chemicals.
阿伐替尼(AVA)是2020年美国食品药品监督管理局(US-FDA)批准的第一种用于治疗无法通过手术治疗的胃肠道间质瘤(GIST)的药物。癌症是全球最常见的死亡原因之一,是仅次于心血管疾病的第二大常见死亡原因。因此,采用了一种快速、简便、灵敏且直接的荧光分析法来分析药物材料和血浆中的阿伐替尼(药代动力学)。所建议的技术依赖于2%十二烷基硫酸钠(SDS,pH 4)胶束体系增强被测药物的荧光。该技术在340 nm激发后,在430 nm处显示出高相对荧光强度(RFI)。使用浓度范围为20.0 - 400.0 ng/mL且定量限为9.47 ng/mL来获取所研究药物的发光数据。此外,随着表面活性剂浓度逐渐增加至高于其临界胶束浓度,阿伐替尼荧光的量子产率增加。这一知识已被用于提高荧光光谱法在人血浆中估算阿伐替尼的有效性(98.95 ± 1.22%)以及进行绿色度评估的均匀性测试。使用US-FDA和国际协调会议(ICH)规则对增强荧光的条件进行了优化和全面验证。这种创新策略被扩展用于研究阿伐替尼在各种情况下人血浆中的稳定性。与使用危险化学品的传统检测方法相比,这种方法是一种环保的解决方案。