摘要
目的:建立高效液相色谱法测定醋甲唑胺片的含量和有关物质。方法:色谱柱为Symmetry—C18(150mm×4.6mm,5μm);流动相为乙腈-0.1mol·L^-1醋酸钠(pH4.5)(20:80);流速:1.0ml·min^-1;检测波长:252am;柱温:30℃;进样量:20μl。结果:醋甲唑胺浓度在10.0—80.0μg·ml^-1范围内峰面积值呈良好的线性关系(r=0.9997),平均加样回收率为99.56%,RSD=0.95%(n=9)。测得3批样品杂质含量分别为0.25%,0.21%,0.23%。结论:本法简便、准确,专属性好,精密度高,专属性好,可用于醋甲唑胺片的含量和有关物质测定。
Objective: To establish a method for the determination of content and related substance of methazolamide tablets by HPLC. Methods: A Symmetry-C18 ( 150mm×4.6mm,5μm) column was used. The mobile phase was acetonitrile 4). 1 mol · L^-1 sodium acetate(pH 4.5)(20: 80). The flow rate was 1.0 ml · min^-1. The detection wavelength was 252 nm. The column temperature was 30℃ and the injection volume was 20 μl. Results: The linear range of methazolamide was 10.0-80.0 μg · ml^-1( r = 0.999 7). The average recovery was 99.56% and RSD was 0.95% (n =9 ). The percentage of the related substance in the three samples was 0.25%, 0. 21% and 0.23%, respectively. Conclusion: The method is simple, accurate and suitable. It can be used in the determi- nation of content and related substance of methazolamide tablets.
出处
《中国药师》
CAS
2015年第7期1223-1225,共3页
China Pharmacist