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| 高效液相色谱法测定尼莫地平固体制剂的溶出度 | |
| 引用本文： | 李帅,李文莉,廖彬,王斌.高效液相色谱法测定尼莫地平固体制剂的溶出度[J].中南药学,2012,10(7):494-497. |
| 作者姓名： | 李帅 李文莉 廖彬 王斌 |
| 作者单位： | 1. 湖南中医药大学,长沙 410208;湖南省食品药品检验研究院,长沙410001 2. 湖南药用辅料检验检测中心,长沙,410014 3. 湖南省食品药品检验研究院,长沙,410001 |
| 基金项目： | 国家药品评价抽验计划质量评价分析(编号:2011067) |
| 摘 要： | 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24 h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. |
| 关 键 词： | 尼莫地平 溶出度 高效液相色谱法 |
HPLC determination of dissolution of nimodipine solid preparation |
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| LI Shuai , LI Wen-li , LIAO Bin , WANG Bin.HPLC determination of dissolution of nimodipine solid preparation[J].Central South Pharmacy,2012,10(7):494-497. | |
| Authors: | LI Shuai LI Wen-li LIAO Bin WANG Bin |
| Institution: | 1.Hunan University of Chinese Medicine,Changsha 410208;2.Hunan Institute for Food and Drug Control,Changsha 410001;3.Hunan Pharmaceutical Excipients Testing and Inspection Center,Changsha 410014) |
| Abstract: | 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. |
| Keywords: | nimodipine dissolution HPLC |
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