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HPLC法测定醋甲唑胺片的含量和有关物质 被引量:2

Determination of Content and Related Substance of Methazolamide Tablets by HPLC
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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
关键词 醋甲唑胺片 高效液相色谱法 含量测定 有关物质 Methazolamide tablets HPLC Content determination Related substance
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