摘要
目的建立利鲁唑片的有关物质及含量测定方法。方法采用十八烷基硅烷键合硅胶柱Agilent TC-C18柱(250 mm×4.6 mm,5μm),以乙腈-水(9∶11)为流动相,有关物质测定的检测波长为221 nm,含量测定的检测波长为254 nm,流速为1.0 mL/min。结果有关物质测定方法专属性良好,检出限为0.32 ng。含量测定平均回收率为99.98%,RSD=0.35%(n=9),利鲁唑进样量线性范围为0.25~0.75μg(r=0.998)。结论该方法简便、准确,可作为该制剂的质量控制方法。
Objective To establish a HPLC method for determining the contents of the related substances in Riluzole Tablets. Methods The Agilent TC - C18 column(250 mm × 4. 6 mm,5 μm)was adopted with the mobile phase of acetonitrile - water(9 : 11)at a flow rate of 1. 0 mL / min. The detection wavelength was 221 nm for the determination of the related substances and 254 nm for the content determination. Results The detection of the related substances had good specificity with the detection limit of 0. 32 ng. The average re-covery rate( n = 9) in the content determination was 99. 98% ,RSD = 0. 35% . The linear range was 0. 25 - 0. 75ug( r = 0. 998). Conclusion This method is simple and accurate,and can be used for the quality control of Riluzole Tablets.
出处
《中国药业》
CAS
2014年第12期76-77,共2页
China Pharmaceuticals
