高效液相色谱法测定烟酸占替诺片的含量及有关物质  

HPLC Determination of Xanthinol Nicotinate Tablets and Its Related Substances

作　　者：王发 杜珊 周至云 

机构地区：[1]陕西省食品药品检验所,陕西西安710061

出　　处：《中国药业》2012年第6期39-40,共2页China Pharmaceuticals

摘　　要：目的建立测定烟酸占替诺片含量及有关物质的高效液相色谱法。方法采用钻石C18柱(150 mm×4.6 mm,5μm),以0.1%三乙胺溶液(用冰醋酸调节pH至3.3)-甲醇(95∶5)为流动相,流速为1.0 mL/min,检测波长为267 nm,柱温为35℃。结果烟酸占替诺质量浓度在9.94～994 mg/L范围内与峰面积呈良好线性关系,线性回归方程为Y=32 024.5 X-71 046.0,r=1.000,方法回收率为99.4%(n=9),RSD为0.2%。茶碱质量浓度在0.33～33 mg/L范围内与峰面积呈良好线性关系,线性回归方程为Y=59 069.9 X-2 595.2,r=1.000,方法回收率为99.0%(n=9),RSD为1.3%。结论所用方法简便准确,专属性强,可用于其产品的质量控制。Objective To establish a HPLC method for the determination of the content of Xanthinol Nicotinate Tablets and its related substances. Methods The adopted chromatorgraphic conditions were： the Cts （150 mm×4.6 mm, 5 μm） column, the mobile phase of 0. 1% triethylamine solution （pH 3.3 adjusted by glacial acetic acid）methanol（95 ： 5） and the flow rate at 1.0 mL/min; the detect wavelength was at 267 nm and the column temperature was 35 ~C. Results Xanthinol nicotinate showed the good linearlty in the con- centration range of 9.94 - 994 rag/L, the linear equation was Y = 32 024.5 X - 71 046. 0（ r = 1. 000）. The recovery rate was 99.4% （ n = 9）, RSD = 0.2%. Theophylline also showed the good linearity in the concentration range of 0.33 - 33 rag/L, the linear equation was Y = 59 069.9X-2 595. 2（ r =1. 000） . The recovery rate was 99.0% （n=9）, RSD=1.3%.Conclusion The method is simple with strong specificity and can be applied to the quality control of Xanthinol Nicotinate Tablets.

关 键 词：高效液相色谱法 烟酸占替诺片 含量 有关物质 

分 类 号：R927.2[医药卫生—药学] R972.4