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.
Sci Rep. 2023 Apr 15;13(1):6165. doi: 10.1038/s41598-023-32904-x.
Quantitative analysis of pharmaceutical compounds up to Nano gram levels is highly recommended to introduce feasible and sensitive tool for determination of the compounds in the pharmaceutical and biological samples. Nirmatrelvir plus ritonavir was recently approved in the US, the UK and Europe as a new co-packaged dosage form for the treatment of COVID-19. The objective of this work was to develop a more sensitive TLC method based on using β-cyclodextrin as a chiral selector additive in the mobile phase for simultaneous determination of nirmatrelvir and ritonavir in pure form, pharmaceutical formulation and spiked human plasma. The analysis procedures were developed using TLC aluminum silica gel plates and methanol-water- 2% urea solution of β-cyclodextrin (40:10:.5, by volume) as a mobile phase with UV detection at 215 nm. The developed method was successfully applied over a linearity range of 10-50 ng/band for both nirmatrelvir and ritonavir. The method was validated for limits of detection and quantitation, accuracy, precision, specificity, system suitability, and robustness. Furthermore, the eco-friendliness of the proposed method was assessed using the analytical eco-scale and the green analytical procedure index. The described method exhibited compliance with green analytical chemistry principles based on common green metric values.
推荐对药物化合物进行纳克级别的定量分析，以引入可行且灵敏的工具来测定药物和生物样品中的化合物。尼马曲韦加利托那韦最近在美国、英国和欧洲被批准为一种新的复方制剂，用于治疗 COVID-19。本工作的目的是开发一种更灵敏的 TLC 方法，即在流动相中使用β-环糊精作为手性选择添加剂，同时测定纯品、制剂和加标人血浆中的尼马曲韦和利托那韦。采用 TLC 铝硅胶板和甲醇-水-2%尿素溶液的β-环糊精（40:10:.5，体积比）作为流动相，在 215nm 处进行紫外检测，开发了分析程序。所开发的方法成功地应用于尼马曲韦和利托那韦的线性范围为 10-50ng/带。该方法已针对检测限和定量限、准确度、精密度、特异性、系统适用性和稳健性进行了验证。此外，还使用分析生态标度和绿色分析程序指数评估了所提议方法的生态友好性。所描述的方法符合基于常见绿色度量值的绿色分析化学原则。
