HPLC法测定复方磺胺嘧啶银混悬液中2种组分的含量

Content Determination of 2 Ingredients in Compound Silver Sulfadiazine Suspension by HPLC

目的:建立测定复方磺胺嘧啶银混悬液中2种组分含量的方法。方法:采用高效液相色谱法。色谱柱为KromasilC18,先以流动相A0.8%三乙胺(pH至4.9)-流动相B甲醇(90:10)进行洗脱,检测磺胺嘧啶银,待其出峰后立即改以流动相A-流动相B(60:40)洗脱10min后检测醋酸氯己定,流速为1.0ml/min,检测波长为260nm,柱温为室温。结果:磺胺嘧啶银和醋酸氯己定的检测质量浓度线性范围分别为0.051～0.153mg/ml(r=0.9999)、20.32～60.96μg/ml(r=0.9999),平均回收率分别为99.3%(RSD=0.75%,n=6)、98.0%(RSD=0.90%,n=6)。结论:本文建立的方法可使磺胺嘧啶银和醋酸氯己定完全分离,避免了相互干扰,且方法简便、灵敏,能有效控制该制剂质量。

OBJECTIVE：To establish a method for content determination of 2 ingredients in Compound silver sulfadiazine suspension.METHODS：HPLC method was adopted.Kromasil C 18 column was used.Mobile phase A 0.8% triethylamine（pH value adjusted to 4.9）-mobile phase B methanol（90：10）was used to elute for the determination of silver sulfadiazine;after peak value appeared,mobile phase A-mobile phase B（60：40）was used to elute for 10 min for the determination of chlorhexidine acetate at the flow rate of 1.0 ml/min.The detection wavelength was set at 260 nm and column temperature was room temperature.RESULTS：The linear ranges were 0.051-0.153 mg/ml for silver sulfadiazine（r=0.999 9）and 20.32-60.96 μg/ml for chlorhexidine acetate（r=0.999 9）.Average recoveries were 99.3%（RSD=0.75%,n=6）and 98.0%（RSD=0.90%,n=6）.CONCLUSIONS：Established method can separate silver sulfadiazine from chlorhexidine acetate completely and avoid mutual interference,and the method is simple,sensitive and effective for the quality control of the preparation.