HPLC法测定尼莫地平渗透泵控释片的含量及有关物质  

Determination of content and related substances of nimodipine osmotic tablets by HPLC

作　　者：孔华[1,2] 刘燕[2] 杨阳[2] 狄忠[1,2] 刘善堂[1] 梅兴国[2] 

机构地区：[1]武汉工程大学化工与制药学院,武汉430073 [2]军事医学科学院毒物药物研究所,北京100850

出　　处：《国际药学研究杂志》2013年第3期355-358,共4页Journal of International Pharmaceutical Research

基　　金：国家科技重大专项综合性新药研究开发大平台(2012ZX09301003-001-009)

摘　　要：目的建立测定尼莫地平渗透泵控释片含量及有关物质的高效液相色谱法。方法采用Venusil MP C18色谱柱(4.6 mm×250 mm,5μm),甲醇-乙腈-水(28∶22∶50)为流动相,检测波长238 nm,流速1.0 ml/min,柱温30℃,进样量10μl。结果溶剂、辅料与各杂质对主药无干扰;线性范围为4.00～40.00μg/ml(r=0.9999);平均回收率为99.60%,RSD为0.72%(n=9)。杂质Ⅰ的检测限与定量限分别为1.3 ng和4 ng。结论本方法是测定该制剂含量及有关物质较理想的方法。Objective To establish an HPLC method for the determination of content and related substances of nimodipine osmotic tablets.Methods The analysis was performed on a Venusil MP C18 column（4.6 mm × 250 mm,5 μm）,using a mobile phase of methanol-acetonitrile-water（28∶ 22∶ 50） at the flow rate of 1.0 ml / min.The column temperature was 30 ℃.The detection wavelength was 238 nm and the injection volume was 10 μl.Results Under the established chromatographic condition,the solvent,excipient and the related substances could be completely separated with nimodipine.A good linear relationship was found between peak area and the concentration of nimodipine in the range of 4.00-40.00 μg / ml（r = 0.9999）.The average recovery was 99.60%（RSD = 0.72 %,n = 9）.The limit of detection and quantitation of impurity Ⅰwere 1.3 ng and 4 ng.Conclusion The method is applicable for the quality control of nimodipine osmotic tablets.

关 键 词：尼莫地平 渗透泵 高效液相色谱法 含量 有关物质 

分 类 号：R927[医药卫生—药学]