Imam Mohamed S, Abdelazim Ahmed H, Ramzy Sherif, Almrasy Ahmed A, Gamal Mohammed, Batubara Afnan S
Pharmacy Practice Department, College of Pharmacy, Shaqra University, Shaqra, 11961, Saudi Arabia.
Clinical Pharmacy Department, National Cancer Institute, Cairo University, Fom El Khalig Square, Kasr Al-Aini Street, Cairo, 11796, Egypt.
BMC Chem. 2023 Sep 21;17(1):120. doi: 10.1186/s13065-023-01030-0.
Ritonavir was recently combined with nirmatrelvir in a new approved co-packaged medication form for the treatment of COVID-19. Quantitative analysis based on fluorescence spectroscopy measurement was extensively used for sensitive determination of compounds exhibited unique fluorescence features.
The main objective of this work was to develop higher sensitive cost effective spectrofluorometric method for selective determination of ritonavir in the presence of nirmatrelvir in pure form, pharmaceutical tablet as well as in spiked human plasma.
Ritonavir was found to exhibit unique native emission fluorescence at 404 nm when excited at 326 nm. On the other hand, nirmatrelvir had no emission bands when excited at 326 nm. This feature allowed selective determination of ritonavir without any interference from nirmatrelvir. The variables affecting fluorescence intensity of ritonavir were optimized in terms of sensitivity parameters and principles of green analytical chemistry. Ethanol was used a green solvent which provided efficient fluorescence intensity of the cited drug.
The method was validated in accordance with the ICH Q2 (R1) standards in terms of linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and specificity. The described method was successfully applied for ritonavir assay over the concentration range of 2.0-20.0 ng/mL.
Ritonavir determination in the spiked human plasma was successfully done with satisfactory accepted results.
利托那韦最近与奈玛特韦以一种新的批准的复方包装药物形式联合用于治疗新冠肺炎。基于荧光光谱测量的定量分析被广泛用于灵敏测定具有独特荧光特征的化合物。
本研究的主要目的是开发一种更灵敏、成本效益高的荧光分光光度法，用于在纯形式、药物片剂以及加标人血浆中存在奈玛特韦的情况下选择性测定利托那韦。
发现利托那韦在326 nm激发时在404 nm处呈现独特的天然发射荧光。另一方面，奈玛特韦在326 nm激发时没有发射带。这一特性使得能够选择性测定利托那韦，而不受奈玛特韦的任何干扰。根据灵敏度参数和绿色分析化学原理，对影响利托那韦荧光强度的变量进行了优化。乙醇用作绿色溶剂，可提供所述药物有效的荧光强度。
该方法根据国际协调会议（ICH）Q2（R1）标准在线性、检测限（LOD）、定量限（LOQ）、准确度、精密度和特异性方面进行了验证。所描述的方法成功应用于2.0 - 20.0 ng/mL浓度范围内的利托那韦测定。
成功地在加标人血浆中测定了利托那韦，结果令人满意。
