毛细管区带电泳法测定枸橼酸昔多芬的含量

Determination of sildenafil citrate content by capillary zone electrophoresis

目的 :建立适合测定治疗男性性功能障碍新药枸橼酸昔多芬 (商品名伟哥 )的毛细管区带电泳分析法 (CZE)。方法 :采用 40 cm× 75μm (i.d)毛细管柱来分离测定样品 ,以粉防己碱为内标 (IS) ,2 5 mm ol/ L硼砂 (p H=7.89)为缓冲溶液 ,电压 14k V、虹吸进样 1s,紫外检测器检测波长 2 14nm。 结果 :在 4m in内可完成枸橼酸昔多芬与内标物的分离和测定 ,该法最低检测浓度为 5 μg/ ml;在 2 4～ 480 μg/ ml范围内线性关系良好 (r=0 .9998,n=5 ) ;日内 RSD<1.5 8%、日间 RSD<2 .46 % ,回收率为 95 %～ 10 5 %。 结论 :CZE法用于枸橼酸昔多芬含量的监测 ,方法准确、可靠、简便、易行。

Objective: To establish capillary zone electrophoresis method for determination of sildenafil citrate (Viagra) content in its troche. Methods: Using tetrandrine as internal standard(IS), the electrophoretic separation was achieved with 25 mmol/L borate (pH=7.89) running buffer. And a voltage of 14 kV was applied to the 40 cm×75 μm(i.d) capillary. The analytes were introduced into capillary by siphon (1 s) and determined with on column monitoring at 214 nm. Results:The determination could be completed within 4 min and the minimum concentration of detection was 5 μg/ml.The analytical results of sildenafil citrate samples demonstrated a good linear relationship within the range of 24 480 μg/ml.The relative standard deviations (RSD) of intra day was less than 1.58% and that of inter day was less than 2.46%.The present recoveries were between 95% 105%. Conclusion:The CZE method is accurate, simple, rapid and reliable, so it can be applied to the determination of sildenafil citrate content.