反相高效液相色谱法测定千金藤啶碱片的含量

目的 :建立反相高效液相色谱测定千金藤啶碱片含量的方法。方法 :采用C18 柱 ,流动相为甲醇 -乙腈 -三乙胺溶液 (60∶20∶20) ,流速为1 0ml/min ,检测波长为284nm ,地西泮为内标物。结果 :对照品在40～160μg/ml范围内线性关系良好 ,回归方程为 :Y=6 65X—0 996 ,r=0 9999 ,平均回收率为99 56 %～100 7 % ,RSD<0 35 % (n=5)。日内RSD<0 25 % (n=6) ,日间RSD<0 60 % (n=5)。结论 :本法简便、可靠、快速、准确 ,可用于测定千金藤啶碱片的含量。

Determination of the Content of Stepholidine in Tablets by RP-HPLC

OBJECTIVE:To establish a RP-HPLC method for determination of the content of stepholidine in tablets.ME_THODS:The HPLC method was performed on KF-C18 column (4.6mm×250mm,10μm),methanol-acetonitrile-triethylamine buffer solution(0.05mol/L,pH adjusted to 3.0 with H3PO4)(60∶20∶20) as mobile phase,diazepam as internal standard.The flow rate was 1.0ml/min,and detection wavelength was set at 284nm.RESULTS:The linear range was 40～160μg/ml(r=0.9 999).The average recovery was 99.56%～100.5% with RSD<0.35%(n=5).The intra-day and inter-day RSDs were less than 0.25%(n=6) and 0.60%(n=5),respectively.CONCLUSION:The method is simple,reliable and accurate,and can be applied to the quality control of the stepholidine tablets.