摘要
目的:建立HPLC法测定磺胺嘧啶混悬液中有关物质的检查方法。方法:采用Capcell PAK MGⅡC18(250 mm×4.6 mm,5μm)色谱柱,流动相A为0.3%乙酸铵溶液,流动相B为乙腈,梯度洗脱,流速为1.0 ml·min^(-1),检测波长为260 nm,柱温为30℃。结果:磺胺嘧啶在0.155 1~15.510 0 mg·ml^(-1)浓度范围内线性关系良好(r=0.999 8),各杂质峰与主峰均能完全分离。杂质A、B、C、D的平均加样回收率分别为101.2%、99.9%、100.8%、103.7%,RSD分别为1.6%、0.8%、0.8%、0.6%(n=9)。结论:本方法专属性强,准确度高,重现性良好,可用于磺胺嘧啶混悬液的质量控制。
Objective： To establish an HPLC method to determine the related substances in sulfadiazine suspension. Methods：The analytical column was Capcell PAK MGⅡ C18（ 250 mm × 4. 6 mm,5 μm）,the mobile phase consisted of 0. 3% ammonium acetate solution（ A） and acetonitrile（ B） at a flow rate of 1. 0 ml·min^-1 with gradient elution,the detection wavelength was 260 nm,and the column temperature was 30℃. Results： The linear range of sulfadiazine was 0. 155 1-15. 510 0 mg·ml^-1（ r = 0. 999 9）. Sulfadiazine and its related substances could be well separated. The average recovery of impurity A,B,C and D was 101. 2%,99. 9%,100. 8% and 103. 7% with the RSD of 1. 6%,0. 8%,0. 8% and 0. 6%（ n = 9）,respectively. Conclusion： The method is good in resolution,reproducibility and sensitivity,which can be used for the quality control of sulfadiazine suspension.
作者
李丹凤
朱健萍
卢日刚
Li Danfeng;Zhu Jianping;Lu Rigang(Guangxi Zhuang Autonomous Region Institute for Food and Drug Control, Nanning 530021, China)
出处
《中国药师》
CAS
2018年第7期1315-1317,1321,共4页
China Pharmacist
