摘要
建立反相高效液相色谱法测定罗红霉素片的溶出度的方法并与《中国药典》2005年版方法比较。采用十八烷基硅烷键合硅胶柱,流动相为0.067mol·L^-1磷酸二氢铵溶液(用三乙胺调节pH值至6.5)-乙腈(65∶35),流速为1.0 mL·min^-1,检测波长为210nm。线性范围:24.43-219.87μg·mL^-1(r=0.9999)。平均回收率为99.5%,RSD=0.84%。试验表明,该方法灵敏度高,简便易行,结果准确,重现性好,适合用于罗红霉素片的溶出度测定。
To develop a method for determination dissolution of roxithromycin tablets by RP-HPLC and compare the difference of this method with that described in ChP(2005).Venusil MP-C18column was used,0.067 mol·L^-1diammonium dihydrogen phosphate solution-acetonitrile(65∶35) was mobile phase,the flow rate was 1.0 mL·min^-1and detection wavelength was 210nm.The calibration curve was linear in the range of 24.43-219.87μg.mL-1(r=0.9999).The average recovery was 99.5%,RSD was 0.84%(n=5).This method is simple,rapid and accurate.
出处
《中国药事》
CAS
2008年第1期70-71,共2页
Chinese Pharmaceutical Affairs