期刊论文

HPLC determination of dissolution of nimodipine solid preparation

中文

中南药学

1672-2981

2012

10

7

494-497

10.3969/j.issn.1672-2981.2012.07.004

国家药品评价抽验计划质量评价分析（编号:2011067）；

本校为第一机构

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）,th...