感冒安片含量测定方法的改进

Improvement on assay method of Ganmao′an Tablets

目的:改进《卫生部药品标准》中感冒安片的含量测定方法,建立测定感冒安片中3个化药组分含量的HPLC方法。方法:色谱柱:Waters XSelect CSH C 18(4.6 mm×250 mm,5μm),流动相:甲醇-水(用冰醋酸调节pH值至2.58)(14∶86),流速1.0 mL·min^-1,检测波长:274 nm(马来酸氯苯那敏和咖啡因)和247 nm(对乙酰氨基酚)。结果:对乙酰氨基酚、咖啡因、马来酸氯苯那敏的线性范围分别为0.01294~0.1294、0.01061~0.1061、0.01052~0.1052 mg·mL^-1,r均为0.9995,平均回收率范围96%~100%。测定样品3批,对乙酰氨基酚、咖啡因、马来酸氯苯那敏含量分别为:101.65%、99.82%、88.64%(L16E011),101.60%、88.47%、89.56%(L16C311),100.59%、96.73%、86.81%(L18H171)。结论:改进后的方法操作简单、准确度高、专属性好,可更准确控制感冒安片的质量。

Objective:To improve the assay method of Ganmao′an Tablets in Drug standard of the Ministry of health and to establish an HPLC method for the determination of three chemical components in Ganmao′an Tablets.Methods:The test was performed in Waters XSelect CSH C 18 column(4.6 mm×250 mm,5μm)under the isocratic elution of methanol-water(adjusting pH to 2.58 with glacial acetic acid)(14∶86).The flow rate was 1.0 mL·min^-1 and the detection wavelengths were 274nm for chlorphenamine maleate and caffeine and 247 nm for paracetamol.Results:The linear ranges of acetaminophen,caffeine and chlorphenamine maleate fell into 0.01294-0.1294 mg·mL^-1,0.01061-0.1061 mg·mL^-1 and 0.01052-0.1052 mg·mL^-1 respectively,with r as 0.9995.The average recoveries were 96%-100%.The test results of 3 batches of samples showed that the contents of paracetamol,caffeine and chlorphenamine maleate were 101.65%,99.82%,88.64%(L16E011);101.60%,88.47%,89.56%(L16C311);100.59%,96.73%,86.81%(L18H171)respectively.Conclusion:The improved method is simple,accurate and specific.It can be more appropriate for quality control of Ganmao′an Tablets.