高效液相色谱法测定尼莫地平固体制剂的溶出度

HPLC determination of dissolution of nimodipine solid preparation

目的建立HPLC法测定尼莫地平固体制剂的溶出度。方法采用HPLC法,以Merck Hibar C18(250mm×4.6mm,5μm)为色谱柱,以甲醇-乙腈-水(35∶38∶27)为流动相,流速为1.0mL·min-1,柱温30℃,检测波长为235nm,同时采用紫外分光光度法测定同一均匀供试品溶液,比较2种方法测定结果的差异。结果尼莫地平在8～40μg·mL-1与峰面积线性关系良好(r=0.999 8,n=5),平均回收率为99.9%(n=9),供试品溶液在24h内稳定。HPLC法测定结果较UV法低2.1%～7.3%。结论本测定方法专属性强、结果准确、稳定性好,更适于该类制剂溶出度的测定。

Objective To establish an HPLC method for the determination of dissolution of nimodipine solid preparation.Methods In this HPLC method,the ingredient was separated on a Merck Hibar C18（250 mm×4.6 mm,5 μm） column.The mobile phase was methanol-acetonitrile-water（35∶38∶27）.The flow rate was 1.0 mL·min-1.The column temperature was 30 ℃,and the detection wavelength was 235 nm.UV method was used to determine the same uniform test solution,and compare the 2 methods.Results The linear range of nimodipine was 8-40 μg·mL-1（r=0.999 8,n=5）,the average recovery was 99.9%（n=9）,and the test solution was stable in 24 h.The result of HPLC method was lower than that of the UV method.Conclusion This method is specific,accurate and stable,and more suitable for the determination of dissolution of nimodipine solid preparation.