摘要
目的制备利福昔明乳剂,并建立利福昔明乳剂的含量测定及有关物质的HPLC方法。方法含量测定采用HPLC法,色谱柱为安捷伦°Eclipse XDB-C8(4.6mm×250mm,5μm),以甲醇-乙腈-缓冲液[0.075mol·L^(-1)磷酸二氢钾溶液-0.5mol·L^(-1)枸橼酸溶液(55∶10)](513∶95∶392)为流动相;流速:1 ml·min^(-1),检测波长:240nm,进样量:20μl,柱温:24℃。结果利福昔明在24～56μg·ml^(-1)范围内线性关系良好(r=0.9994),含量测定溶液在9h内稳定,RSD为0.51%,辅料对有关物质检验没有影响。结论本方法灵敏、准确、专属性强,可以作为利福昔明乳剂的质量标准。
Objective To prepare a rifaximin emulsion and establish an HPLC method for quantitative analysis and related substances of the rifaximin emulsion.Methods The chromatographic column was Agilent°Eclipse XDB-C8(4.6 mm×250 mm,5μm)with methanol-acetonitrile-buffer solution[0.075 mol·L^-1 potassium dihydrogen phosphate solution-0.5 mol·L^-1 citric acid solution(55∶10)](513∶95∶392)as the mobile phase at a flow rate of 1 ml·min^-1.The detection wavelength was set at 240 nm,the injection volume was 20μl,and the column temperature was 24℃.Results A good linear relationship of rifaximin was observed within the range of 24-56μg·ml^-1(r =0.9994).The quantitative analysis solutionwas stable in 9 hours with an RSD of 0.51%.The excipients had no effect on the determination of related substances.Conclusion This method is sensitive,accurate and specific.Itcanbeusedasa quality standard for the rifaximin emulsion.
作者
王娜
刘晓磊
姜波
王世岭
WANG Na;LIU Xiao-lei;JIANG Bo;WANG Shi-ling(Heilongjiang Doctor Tong Children's Biopharmaceutical Co.,Ltd,Haerbin 150025,China)
出处
《解放军药学学报》
CAS
CSCD
2018年第6期536-537,541,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
利福昔明
乳剂
含量测定
有关物质
rifaximin
emulsion
content determination
related substances
