摘要
目的建立测定醋酸甲萘氢醌片含量的反相高效液相色谱法。方法采用Welch Materials C18色谱柱(150 mm×4.6 mm,5μm),以乙腈-水(65∶35)为流动相,检测波长285 nm,流速1.0 mL/min,进样量20μL。结果醋酸甲萘氢醌质量浓度在4.0~60.0μg/mL范围内与峰面积线性关系良好(r=1.000),平均回收率99.93%,RSD=1.21%(n=9)。结论所用方法简便,重复性好,结果准确可靠,可作为醋酸甲萘氢醌制剂的质量控制方法。
Objective To determine the content of Menadiol Diacetate Tablets by RP-HPLC.Methods The chromatographic column was Welch Materials C18 column(150 mm×4.6 mm,5 μm) with acetonitrile-water(65 ∶35) as the mobile phase,the detective wavelength was 285 nm and the flow rate was 1.0 mL/min.The amount of injection was 20 μL.Results The calibration curve of menadiol diacetate was linear in the range of 4.0-60.0 μg/mL,the average recovery rate was 99.93%(n=9).Conclusion The method is simple,accurate,reliable and reproducible,which can be used for the determination both the raw material and preparations and the quality control of Menadiol Diacetate Tablets.
出处
《中国药业》
CAS
2011年第1期24-25,共2页
China Pharmaceuticals
基金
国家药典委员会2010版药典科研项目