Ahmed Rasha M
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Misr International University, Cairo, Egypt.
Heliyon. 2021 Dec 1;7(12):e08521. doi: 10.1016/j.heliyon.2021.e08521. eCollection 2021 Dec.
Ecological, sensitive, fast and economic approaches are the main aspects in quality control of pharmaceutical products. Elagolix (ELG) is an orally non-peptidic GnRH antagonist, recently approved drug by Food and drug administration in 2018 for treatment of pain associated with endometriosis. A green, and sensitive method was developed and validated for determination of ELG based on micellar spectrofluorometric approach. Many factors were studied to enhance the fluorescence intensity of ELG and the highest sensitivity was obtained upon using 1% Sodium dodecyl sulphate (SDS) at 438 nm after excitation at 270 nm. A linear relationship was obtained over a range of 50-1000 ng mL between ELG concentration and corresponding fluorescence intensity. The developed method was validated according to ICH guidelines and successfully applied for testing the content uniformity and determination of ELG in pharmaceutical dosage forms with percentage recovery 99.31 ± 1.98. Furthermore, the capability of the method due to its high sensitivity to determine ELG in human plasma with percentage recoveries in a range of 98.54-100.46. The greenness of the method was investigated using three different approaches; Analytical Procedure Index (GAPI), Analytical Eco-Scale and Analytical Greenness Metric (AGREE).
生态、灵敏、快速和经济的方法是药品质量控制的主要方面。艾拉戈利克（ELG）是一种口服非肽类促性腺激素释放激素（GnRH）拮抗剂，于2018年最近获得美国食品药品监督管理局批准用于治疗与子宫内膜异位症相关的疼痛。基于胶束荧光光谱法开发并验证了一种绿色且灵敏的测定ELG的方法。研究了许多因素以增强ELG的荧光强度，在270nm激发后，使用1%十二烷基硫酸钠（SDS）在438nm处获得了最高灵敏度。在50 - 1000ng/mL范围内，ELG浓度与相应荧光强度之间获得了线性关系。所开发的方法根据国际人用药品注册技术协调会（ICH）指南进行了验证，并成功应用于检测药品剂型中ELG的含量均匀度和测定，回收率为99.31±1.98%。此外，该方法因其对人血浆中ELG的高灵敏度而具有测定能力，回收率在98.54 - 100.46%范围内。使用三种不同方法研究了该方法的绿色度；分析程序指数（GAPI）、分析生态尺度和分析绿色度指标（AGREE）。
