HPLC法测定尼莫地平软胶囊的含量及有关物质  

HPLC determination of nimodipine soft capsules and its related substances

作　　者：郝桂明[1] 华莲[1] 唐素芳[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《药物分析杂志》2012年第3期464-467,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC法测定尼莫地平软胶囊的有关物质及含量。方法:采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm),以甲醇-乙腈-水(35∶38∶27)为流动相,流速1.0mL.min-1,柱温为40℃,检测波长为235 nm。结果:尼莫地平和杂质A均在0.1～4.0μg.mL-1浓度范围内与其峰面积呈良好线性关系(r=1.0000),最低检出限均为0.4 ng。高、中、低3种浓度的平均回收率为99.6%,RSD为0.5%(n=9)。结论:该方法简便准确,重复性好,可用于尼莫地平软胶囊的有关物质和含量测定。Objective：To establish an RP-HPLC method for determination of the related substances and the content of nimodipine soft capsules.Method：The chromatographic separation was achived on a Diamonsil C18（250 mm×4.6 mm,5 μm）Column with the mobile phase of methanol-acetonitrile-water（35∶ 38∶ 27）.The flow rate was 1.0 mL·min-1with column temperature at 40 ℃.The detection wavelength was 235 nm.Results：The calibration curve was linear within the range of was 0.1-40 μg·mL-1for nimodipine and 0.1-4.0 μg·mL-1（r=0.999 99）for nimodipine related compound A.The average recoveries were 99.6% and RSD was 0.5%（n=9）.Conclusion：The method is simple,accurate and reproducible for determination of nimodipine soft capsules.

关 键 词：钙拮抗剂 尼莫地平软胶囊 光降解产物 杂质 质量控制 标准提高 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]