硝苯地平分散片的质量控制

目的：建立硝苯地平分散片中硝苯地平的质量控制方法,保证该制剂质量.方法：采用高效液相色谱法测定硝苯地平的含量,色谱柱为Kromasil-C1s柱（200 mm×4.6 mm,5 μm）,甲醇-水（65：35）为流动相,检测波长为237 nm,流速为0.8 mL/min,进样量为20μL,柱温为室温.结果：硝苯地平的含量为标示量的100.09％;在5.0～35.0 μg/mL的浓度范围内与峰面积线性关系良好;平均回收率为100.07％.制剂有关物质检测合格.结论：高效液相色谱法专属性好,操作方便,结果准确,重现性好,能有效地控制硝苯地平分散片的质量.

Quality control of nifedipine dispersible tablets

Objective：To establish a method for the quality control of the nifedipine in the nifedipine dispersible tablet and maintain the quality of the test tablets.Methods：The concentration of nifedipine were determined by HPLC; column was represented by Kromasil-C18 （200 mm×4.6 mm,5 μm） while mobile phase,methanol-water （65：35） ; the examine wavelength was 237 nm,velocity of flow 0.8 mL/ min; the injection volume was 20 μL at room temperature.Results：The content of nifedipine was 100.09% of labeled amount.At the concentration of nifedipine between 5.0～35.0 μg/mL,it indicated a fine linear relationship with peak aera,with the average recovery rate of 100.07%.The substances of the test tablets were qualified to standard.Conclusion：The method is efficient,simple,accurate and replicable.It can be used for quality control of the nifedipine dispersible tablet.