摘要
目的:采用RP-HPLC法测定氨苯蝶啶片的含量及有关物质检查。方法:采用C18柱,以0.01 mol.L-1庚烷磺酸钠溶液(用20%磷酸调节pH值至2.7)-乙腈(7∶3)为流动相,检测波长为360 nm。结果:氨苯蝶啶在0.5～6.3μg的范围内呈良好的线性关系,相关系数为r=0.999 5,平均回收率为99.9%,RSD值0.1%;且供试品图谱中除氨苯蝶啶主峰外,还有两个面积较大的杂质峰。结论:方法简便、专属性强。可用于氨苯蝶啶片的含量及有关物质的测定。
Objective： An RP-HPLC method was developed for the determination of Triamterene Tablets and related substances. Methods： The cyano column was used, and 0. 01mol. L-1 heptanesulfonate sodium solution （adjusted to pH 2. 7 with 20% phosphoric acid ） - acetonitrile （7：3 ） as mobile phase, the detection wavelength was set at 360 nm. Results： The linear range was within 0. 5-6. 3 μg （ r = 0. 999 5 ）. The average recovery rate was 99.9% （ RSD = 0. 1% ） ; and there were two larger impurity peaks in triamterene HPLC chromatograms. Conclusion： The method is simple and reliable, and can be used in determination of Triamterene Tablets and related substances.
出处
《中国药品标准》
CAS
2012年第3期191-193,共3页
Drug Standards of China
