摘要
目的：肌醇烟酸酯片为高脂血症治疗药物，原标准采用UV吸收系数法测定含量，易受辅料、溶剂等干扰。本文研究建立高效液相色谱法，测定肌醇烟酸酯片含量，为提高标准提供参考。方法：采用Venusil ASB C8（4．6mm×250mm，5μm）色谱柱；流动相：甲醇．磷酸二氢钾缓冲液（pH6．5）-（60：40）；流速：0．8mL·min^-1；检测波长：264nm；柱温为30℃。对方法进行了验证，并收集10个制药企业的10批样品，用2种方法进行了测定。结果：方法验证结果，线性范围：22．22～199．98μg·mL^-1，r=0．9999，平均回收率为100．1％，RSD=0．9％（n=9）。2种方法测定样品的结果基本一致。结论：本文建立的方法简便，专属性强，可用于肌醇烟酸酯片的含量测定，为标准改进提供参考。
Objective： Inositol nicotinate tablets belong to a medicine for treating hyperlipidemia. The original standard uses UV absorption coefficient method to determine the content, which is susceptible to interference of accessories, solvents, etc. In this paper, a HPLC method was established to measure the content of inositol niacinate in tablets to provide reference for improving the standard. Methods： a Venusil ASB C8 （4.6 mm×250 mm, 5 μm） column was adopted with methanol-potassium dihydrogen phosphate buffer solution （pH 6.5） （60 ： 40）, the flow rate was 0.8 mL·min-1, the detection wavelength was 264 nm, and the column temperature was at 30 ℃ . This method has been verified. The 10 batches of samples from 10 pharmaceutical enterprises were collected for determination of inositol niacinate tablets by two methods. Results： Method validation results were as follows, the calibration curve of inositol niacinate was in good linearity over the range of 22.22-199.98 μg · mL-1 （r=0.9999）. The average recovery was 100.1% with RSD 0.9% （n=9）. The results of two methods for determination were basically the same. Conclusion： The method developed in this article is simple and specific, which can be used for the determination of inositol niacinate in tablets and can provide reference for improving the standard.
出处
《中国药事》
CAS
2015年第2期189-193,共5页
Chinese Pharmaceutical Affairs
关键词
药品质量标准提高
肌醇烟酸酯片
含量测定方法改进
紫外吸收系数法
高效液相色谱法
improvement of drug quality standards
inositol niacinate tablets
improvement of determinationmethod
ultraviolet absorption coefficient method
high performance liquid chromatography
