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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(150 mm×4.6 mm,5μm);流动相为乙腈-0.1 mol·L-1醋酸钠(p H 4.5)(20∶80);流速:1.0 ml·min-1;检测波长:252 nm;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=0.999 7),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 substances of acetomethazirine tablets by high performance liquid chromatography. METHODS: The column was Symmetry-C18 (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-0.1 mol·L-1 sodium acetate (pH 4.5) (20:80) ; Detection wavelength: 252 nm; column temperature: 30 ℃; injection volume: 20μl. Results: The calibration curve was linear over the range of 10.0 ~ 80.0 μg · ml-1 (r = 0.999 7), with an average recovery of 99.56% and a RSD of 0.95% (n = 9 ). Measured three batches of sample impurity content were 0.25%, 0.21%, 0.23%. Conclusion: This method is simple, accurate, specific, good precision, specificity, and can be used for the determination of content and related substances of methazolamide tablets.