Contreras María Del Mar, Morales-Soto Aránzazu, Segura-Carretero Antonio, Valverde Javier
Department of Analytical Chemistry, Faculty of Sciences, University of Granada, Avenida Fuentenueva s/n, 18071 Granada, Spain.
Research and Development Functional Food Centre (CIDAF), Bioregión Building, Health Science Technological Park, Avda. Del Conocimiento s/n, 18016 Granada, Spain.
J Pharm Anal. 2017 Aug;7(4):208-213. doi: 10.1016/j.jpha.2017.04.003. Epub 2017 Apr 14.
Sofosbuvir is one of the new direct-acting antiviral drugs against hepatitis C virus (HCV) infection. This drug has recently been launched into the market, and generic versions of the medication are expected to be produced by local drug producers in some countries. Therefore, new methods are required to control sofosbuvir in pharmaceuticals. In the present study, a new method based on reversed phase (RP)-ultra-high performance liquid chromatography (UHPLC) coupled to diode array detection (DAD) and mass spectrometry (MS) was developed to facilitate the qualitative and quantitative analysis of sofosbuvir in film coated tablets. A wavelength of 260 nm was selected to perform a cost-effective quantification and the method showed adequate linearity, with an value of 0.9998, and acceptable values of accuracy (75%-102%) and precision (residual standard deviation <5%). The detection and quantification limits were 0.07 μg/mL and 0.36 μg/mL, respectively. Furthermore, the use of high-resolution MS enabled us to ensure the specificity, check impurities and better sensitivity. Therefore, this methodology promises to be suitable not only for the routine analysis of sofosbuvir in pharmaceutical dosage forms, but also for potential degradants.
索磷布韦是一种新型的抗丙型肝炎病毒（HCV）感染的直接作用抗病毒药物。该药物最近已投放市场，预计一些国家的当地药品生产商将生产其仿制药。因此，需要新的方法来控制药品中的索磷布韦。在本研究中，开发了一种基于反相（RP）-超高效液相色谱（UHPLC）结合二极管阵列检测（DAD）和质谱（MS）的新方法，以促进对薄膜包衣片中索磷布韦的定性和定量分析。选择260nm波长进行经济高效的定量分析，该方法显示出足够的线性，r值为0.9998，准确度（75%-102%）和精密度（剩余标准偏差<5%）值均可接受。检测限和定量限分别为0.07μg/mL和0.36μg/mL。此外，使用高分辨率质谱使我们能够确保特异性、检查杂质并提高灵敏度。因此，该方法不仅有望适用于药物剂型中索磷布韦的常规分析，也适用于潜在的降解产物。
