摘要
目的建立了罗红霉素颗粒中3种对羟基苯甲酸酯类防腐剂的HPLC测定方法。方法色谱柱为Diamonsil C18柱,流动相A为0.005mol·L-1的醋酸铵溶液(每1000mL中含三乙胺10mL,用冰醋酸调节pH值至5.0±0.5)-乙腈(50∶50),检测波长为256nm。结果羟苯甲酯、羟苯乙酯及羟苯丙酯色谱峰间及与其他成分峰均能有效分离,线性关系良好(r=0.9999),羟苯甲酯、羟苯乙酯及羟苯丙酯的平均回收率分别为98.9%、99.0%和95.8%,检测限分别为2.3、2.2和2.3μg·L-1,羟苯乙酯测定重复性RSD为0.1%。结论方法准确、简便、灵敏,可用于本品的质量控制。
OBJECTIVE To develop a HPLC method for the determination of 3 kinds of phydroxybenzoate antiseptics in roxithromycin granules. METHODS The column was Diamonail C18. The mobile phase consisted of 5mmol · L^-1 ammonium acetate solution （ containing 1% triethylamine,adjusting to pH 5.0±0. 5 by acetic acid）acetonitrile （ 1：1 ）. The detection wavelength was 256nm. RESULTS Good separation of methylparaben, ethylparaben, propylparaben and other components could be achieved in the chromatographic condition. The linear range was good （ r = 0. 9998）. The average recoveries for methylparaben, ethylparaben, propylparaben were 98.9% ,99.0% and 95.8% respectively. The detection limits for methylparaben,ethylparaben,propylparaben were 2. 3,2. 2 and 2. 3μg·L^-1 respectively. The RSD of precision for ethylparaben was 0. 1%. CONCLUSION The method is accurate, simple, sensitive, and can be used for quality control of roxithromycin granules.
出处
《海峡药学》
2013年第8期80-82,共3页
Strait Pharmaceutical Journal
