硝苯地平缓释片含量测定及体外释药机理研究

Content Determination and Release Mechanism of Nifedipine Sustained Release Tablets

目的建立测定硝苯地平缓释片中硝苯地平含量的高效液相色谱（HPLC）法。方法色谱柱为Diamonsil C18柱（250 mm×4.6 mm,5μm）,流动相为甲醇-水（60∶40）,检测波长为237 nm,流速为1 m L/min,柱温为30℃。结果硝苯地平对照品溶液质量浓度在4.83～43.55μg/m L（r=0.999 9）范围内与峰面积呈良好线性关系,精密度、重复性试验结果的RSD分别为0.91%和1.46%（n=6）,平均回收率为99.94%,RSD为0.74%（n=9）。结论该方法简便、快速、灵敏、重复性好,可用于硝苯地平缓释片的质量控制。

Objective To establish a method for the content determination of nifedipine in Nifedipine Sustained Release Tablets by HPLC.Methods The chromatographic separation condition of determination was as follows：Diamonsil C18column（250 mm×4.6 mm,5 μm）.The mobile phase consisted of methanol-water（60 ∶40） with the flow rate of 1.0 m L / min.The wave length of detection was 237 nm and the column temperature was maintained at 30 ℃.Results The standard curve of nifedipine was linear within range of 4.83-43.55 μg / m L（r =0.999 9）.RSD of precision and reproducibility were 0.91% and 1.46%（n =6）,respectively.Average of recovery was99.94% with RSD of 0.74%（n =9）.Conclusion The determination method of content by HPLC is simple,quick,sensitive,fine reproducibility,which could be used to control the quality of nifedipine sustained release tablets.