法匹拉韦片的溶出度研究及其方法学验证

A method for determining the dissolution of favipiravir tablets and methodological study

目的建立并验证法匹拉韦片的溶出度测定方法。方法法匹拉韦片以醋酸-醋酸钠缓冲液(pH 4.5,900 ml)为溶出介质,采用桨法(转速为50 r/min),于15 min时取样,紫外-可见分光光度法在360 nm波长处测定吸光度,计算溶出度。结果与结论法匹拉韦片各批次溶出度均在85%以上,所建立的溶出度测定方法快速准确、重现性好,可用于法匹拉韦片溶出度的测定。

Objective To establish and validate a method for determining the dissolution of favipiravir tablets.Methods For favipiravir,acetate-acetate buffer solution(900 ml,pH 4.5)was used as the dissolution medium,and the paddle was rotated at 50 revolutions per minute.At 15 minutes,a sample of the medium taken through an inline filter was as test solutions.The absorbance was measured at the wavelength of 360 nm by UV-Vis spectrophotometry,and the dissolution was calculated.Results and Conclusion The dissolution of each batch of favipiravir tablets was above 85%.This method of dissolubility determination is highly sensitive,accurate,and repeatable,which can be used for the determination of dissolution of favipiravir tablets.