高效液相色谱法同时测定口服液体制剂中8种防腐剂

Simultaneous Determination of Eight Preservatives in Oral Liquid Preparations by High Performance Liquid Chromatography

目的建立高效液相色谱法同时测定口服液体制剂中苯甲酸、山梨酸、脱氢乙酸、苯甲醇、对羟基苯甲酸甲酯、羟苯乙酯、羟苯丙酯、对羟基苯甲酸丁酯8种防腐剂含量的方法。方法Agilent ZORBAX Extend XDB-C_(18)(4.6×250 mm,5μm),流动相A为20 mmol·L^(-1)乙酸铵;流动相B为甲醇,梯度洗脱,流速1 mL·min^(-1),检测波长230 nm和254 nm,柱温30℃,进样量10μL。结果方法线性范围在0.2~20μg·mL^(-1),相关系数R^(2)≥0.9992,检出限(S/N=3)为0.007~0.1μg·mL^(-1),加标平均回收率为99.4%~100.2%(RSD为0.1%~0.5%)。结论方法操作简单,灵敏度高,适用于口服液体制剂中防腐剂含量检测。

OBJECTIVE To establish a HPLC method for simultaneous determination of 8 preservatives in oral liquid preparations,including benzoic acid,sorbate,dehydroacetic acid,benzyl alcohol,methyl parabens,hydroxyphenylate,hydroxypropyl parabens and butyl parabens.METHODS Agilent Zorbax extend xdb-C_(18)(4.6×250 mm,5μm),mobile phase A was 20 mmol·L^(-1) ammonium acetate.Mobile phase B was methanol,gradient elution,flow rate 1 mL·min^(-1),detection wavelength 230 nm and 254 nm,column temperature 30℃,injection volume 10μL.RESULTS The linear range of the method was 0.2-20μg·mL^(-1),linear correlation coefficient R^(2)≥0.9992,detection limit(S/N=3)was 0.007-0.1μg·mL^(-1),the average recovery of spiked standard was 99.4%~100.2%(RSD was 0.1%~0.5%).CONCLUSION The method is simple,sensitive and suitable for the determination of preservatives in oral liquid preparations.