El-Yazbi Amira F
University of Alexandria, Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, El-Messalah, Alexandria 21521, Egypt.
J AOAC Int. 2017 Jul 1;100(4):1000-1007. doi: 10.5740/jaoacint.16-0295.
Sofosbuvir (SOFO) was approved by the U.S. Food and Drug Administration in 2013 for the treatment of hepatitis C virus infection with enhanced antiviral potency compared with earlier analogs. Notwithstanding, all current editions of the pharmacopeias still do not present any analytical methods for the quantification of SOFO. Thus, rapid, simple, and ecofriendly methods for the routine analysis of commercial formulations of SOFO are desirable. In this study, five accurate methods for the determination of SOFO in pharmaceutical tablets were developed and validated. These methods include HPLC, capillary zone electrophoresis, HPTLC, and UV spectrophotometric and derivative spectrometry methods. The proposed methods proved to be rapid, simple, sensitive, selective, and accurate analytical procedures that were suitable for the reliable determination of SOFO in pharmaceutical tablets. An analysis of variance test with P-value > 0.05 confirmed that there were no significant differences between the proposed assays. Thus, any of these methods can be used for the routine analysis of SOFO in commercial tablets.
索磷布韦(SOFO)于2013年获美国食品药品监督管理局批准,用于治疗丙型肝炎病毒感染,与早期类似物相比,其抗病毒效力更强。尽管如此,现行所有版本的药典仍未提供任何定量测定索磷布韦的分析方法。因此,需要快速、简便且环保的方法来对索磷布韦商业制剂进行常规分析。在本研究中,开发并验证了五种测定药片中索磷布韦的准确方法。这些方法包括高效液相色谱法、毛细管区带电泳法、高效薄层色谱法以及紫外分光光度法和导数光谱法。所提出的方法被证明是快速、简便、灵敏、选择性好且准确的分析程序,适用于可靠测定药片中的索磷布韦。P值>0.05的方差分析测试证实,所提出的测定方法之间无显著差异。因此,这些方法中的任何一种都可用于商业药片中索磷布韦的常规分析。