HPLC测定复方妥布霉素滴眼液中苯扎氯铵含量  

Determination of Benzalkonium Chloride in Compound Tobramycin Eye Drops by HPLC

作　　者：易大为[1] 王静[2] 刘亚威[1] 张亚杰[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]沈阳市铁西区中心医院,沈阳110021

出　　处：《食品与药品》2012年第9期340-342,共3页Food and Drug

摘　　要：目的建立HPLCN定复方妥布霉素滴眼液中苯扎氯铵含量的方法。方法以辛烷基硅烷键合硅胶为填充剂；以0．1mol／L乙酸钠溶液（冰乙酸调pH至5．0）-乙腈（40：60）为流动相；检测波长262nm；流速1．0mL／min；柱温35℃；进样量20此。结果苯扎氯铵在0．0645-1．613μg范围内呈良好的线性关系（r=1．000）；苯扎氯铵的检测限为8．5ng，定量限为21．3ng；苯扎氯铵平均回收率为100．8％（n=9），RSD=1．1％；空白溶液对苯扎氯铵测定无干扰。结论此法准确、可靠，可有效地控制复方妥布霉素滴眼液中苯扎氯铵的含量。Objective To establish a HPLC method for the determination of benzalkonium chloride in Compound Tobramycin Eye Drops. Methods Stationary phase was octylsilane bonded silica. Mobile phase was the mixture of 0.1M sodium acetate buffer（pH 5.0）-acetonitrile （40：60）. The detection wavelength was 262 nm. The flow rate was 1.0 mL/min. The column temperature was 35~C and the injection volume was 20 gL. Results A good linear relationship was found within the range of 0.0645 μg- 1.613 μg for benzalkonium chloride （r=1.000） . The limit of detection was 8.5 ng and the limit of quantification was 21.3 ng. The average recovery was 100.8% （n=9） with RSD of 1.1%. The blank solution did not affect the determination of benzalkonium chloride. Conclusion The method can be accurate and reliable, and can effectively control the content ofbenzalkonium chloride in Compound Tobramycin Eye Drops.

关 键 词：复方妥布霉素滴眼液 苯扎氯铵 高效液相色谱法 

分 类 号：R779.12[医药卫生—眼科]