摘要
目的研究HPLC法测定亚硫酸氢钠甲萘醌注射液的含量。方法采用SinoChromODS-BP C18(200mm×4.6mm,5μm)色谱柱,大连依利特分析仪器有限公司;流动相:0.015mol/L磷酸二氢钠溶液-甲醇(70:30,用磷酸调节pH至4.8±0.1),检测波长230nm。流速1.0ml/min,柱温:30℃。并进行了方法学验证。结果在0.08～2.40μg范围内,色谱峰面积与对照品浓度呈良好的线性关系,r=0.9999;回收率为99.8%(n=18)。结论该法快速、简便、准确,可用于亚硫酸氢钠甲萘醌注射液的质量控制。
Objective To established a method to determine the contents of Menadione Sodium Bisulrite in Menadione Sodium Bisulfite Injection. Method Used an RP-HPLC method with SinoChromODS C18 column （ 200 mm ×4. 6 mm,5μm） ,the mobile phase was a mixture of 0. 015 mol/L NaH2PO4 buffer solutionmethanol （70： 30）, the flow rate wasl. 0 ml .min-1 and the detection wavelength was 230 nm. Results The calibration curve was linear in the range of 0. 08 -2. 40 μg （r =0. 9999）. The average recovery was 99. 8% （n = 18 ）. Conclusion The method is fast, simple and accurate, it can be used for the quality control of Menadione Sodium Bisulfite in Menadione Sodium Bisulfite Injection.
出处
《中国实用医药》
2009年第27期33-34,共2页
China Practical Medicine
