摘要
目的:完善改变剂型的制剂舒泌通片的质量控制方法。方法:采用薄层鉴别和高效液相色谱法,其中含量测定以蒙花苷为对照品,检测波长为334nm,甲醇-水-冰醋酸(26∶23∶1)为流动相。结果:通过方法学考察,蒙花苷进样量在0.051 0～0.663 0μg范围内呈良好的线性关系,平均回收率为99.08%,RSD为0.93%。结论:薄层鉴别,方法专属,斑点清晰;含量测定方法简便,准确,重复性好,无干扰,可有效控制舒泌通片的质量。
Objective： In this article, to study quality standard and edit thin-layer identification and determination method for changing preparation of Shumitong Tablets. Methods ： Comparison with Buddleoside standard substance, the Buddleoside content in Tablets was determined by HPLC method, with 334 nm as the detetion wavelength and methanol-water-glacial acetic acid solution（26： 23：1 ） as the mobile phase. Results：h was demonstrated, when injected volume of Buddleoside ranges from 0. 015 0 to 0. 663 0 μg, the result has a good linear regression, the average recovery was 99.08%, and the RSD was 0. 93%. Conclusion： This method is accurate and reliable and can be used for differentiating and determination of Buddleoside content.
出处
《中国药品标准》
CAS
2009年第3期189-192,共4页
Drug Standards of China
