HPLC法同时测定盐酸林可霉素滴眼液中有关物质和防腐剂含量

目的：建立同时测定盐酸林可霉素滴眼液中有关物质和防腐剂（苯扎溴铵、羟苯乙酯、苯甲酸钠、硫柳汞钠）含量的方法。方法：采用高效液相色谱法。色谱柱为PhenomenexLunaC。s，流动相为磷酸缓冲液（pH6．1）-甲醇-乙腈（77：8：15），流速为1．0ml／min，检测波长为210nm，柱温为50cC。结果：林可霉素、苯扎溴铵、羟苯乙酯、苯甲酸钠、硫柳汞钠在各自的检测质量浓度范围内线性关系良好，r为0．9999～1．0000，检测限分别为1．05、1．5、2．5、1．2、1ng；4种防腐剂的平均回收率为99．3％～101．2％（RSD≤1．1％，n=9）。结论：本文建立的方法结果准确可靠，可作为盐酸林可霉素滴眼液中有关物质和防腐剂的控制方法。

Content Determination of Related Substances and Antiseptic in Lincomycin Hydrochloride Eye Drops by HPLC

OBJECTIVE： To establish the method for content determination of related substances and antiseptic （benzalkonium bromide, ethylparaben, sodium benzoate, merthiolate） in Lincomycin hydrochloride eye drops. METHODS： HPLC method was ad- opted. The separation was performed on Phenomenex Luna C~8 column with phosphoric acid buffer （pH 6.1 ）-methanol-acetonitrile （77 ： 8 ： 15） as mobile phase at the flow rate of 1.0 ml/min. The detection wavelength was set at 210 nm and column temperature was 50 ~. RESULTS： The calibration curves of lincomycin, benzalkonium bromide, ethylparaben, sodium benzoate, merthiolate revealed good linearity （r----0.999 9-1.000 0）. The detection limits were 1.05, 1.5, 2.5, 1.2 and 1 rig. Average recoveries of 4 kinds of antiseptic were 99.3%-101.2% （RSD~〈l.1%, n=9）. CONCLUSIONS： Result of determination is accurate and reliable. This method is suitable for quality control of related substances and antiseptic in Lincomycin hydrochloride eye drops.