HPLC法测定氢溴酸山莨菪碱片的含量及含量均匀度  

Determination of Content and Content Uniformity in Anisodamine Hydrobromide Tablets by HPLC

作　　者：高微[1] 邵海云[1] 张吉娟[1] 李凤华[1] 王宗立[1] 黄雨蒙[1] 王萌萌[1] 王超众 

机构地区：[1]齐齐哈尔市第一医院,黑龙江齐齐哈尔161005 [2]齐齐哈尔市食品药品检验检测中心,黑龙江齐齐哈尔161006

出　　处：《中国药房》2015年第9期1284-1285,共2页China Pharmacy

摘　　要：目的：建立测定氢溴酸山莨菪碱片的含量和含量均匀度的方法。方法：采用高效液相色谱法。色谱柱为Sun Fire C8,流动相为乙腈-0.1%庚烷磺酸钠溶液（用磷酸调节p H值至2.5）（40∶60,V/V）,流速为1.0 ml/min,柱温为28℃,检测波长为256 nm,进样量为10μl。结果：氢溴酸山莨菪碱的质量浓度在2.5~100μg/ml范围内与峰面积呈良好的线性关系（r=0.999 9）;精密度、重复性、稳定性试验的RSD〈1%;平均加样回收率为99.27%,RSD为0.67%（n=9）。结论：该方法简便、快速、准确,适用于氢溴酸山莨菪碱片的含量及含量均匀度的测定。OBJECTIVE：To establish a method for the determination of content and content uniformity in Anisodamine hydrobromide（AH） tablets. METHODS：HPLC was conducted with the Sun Fire C8 column. The mobile phase was acetonitrile-0.1%heptane sulfonic acid sodium solution（p H was adjusted to 2.5 by phosphoric acid）（40∶60,V/V）,the detection wavelength was256 nm,the flow rate was 1.0 ml/min,the column temperature was 28 ℃ and sampling volume was 10 μl. RESULTS：There was a good linear relationship between the quality concentration of AH and peak area in the range of 2.5-100 μg/ml（r=0.999 9）;the RSDs of precision,repeatability and stability test were less than 1%;the recovery rate was 99.27%（RSD=0.67%,n=9）. CONCLUSIONS：The method is simple,rapid and accurate. It can be used for the quality control of AH tablets.

关 键 词：氢溴酸山莨菪碱片 高效液相色谱法 含量 含量均匀度 质量控制 

分 类 号：R927.2[医药卫生—药学]