HPLC测定苄达赖氨酸滴眼液中3种抑菌剂含量

Determination of Three Bacteriostatic Agents in Bendazac Lysine Eye Drops by HPLC

关键词:  苄达赖氨酸滴眼液  抑菌剂  含量  高效液相色谱法

Key words:  bendazac lysine eye drops  bacteriostatic agents  contents  HPLC

摘要:

目的 建立同时测定苄达赖氨酸滴眼液中3种抑菌剂(羟苯乙酯、硫柳汞、苯扎氯铵)含量的高效液相色谱法。方法 Kromasil C₁₈色谱柱(4.6 mm×250 mm，5 μm)；流动相：1%三乙胺溶液(用磷酸调pH值至3.0)(A)-甲醇(B)，梯度洗脱：0~2?min，B 50%；2~17 min，B 50%→90%；17~29 min，B 90%；29~30 min，B 90%→50%；流速：1.0 mL·min^-1；检测波长：262 nm；进样量：20 μL；柱温：40 ℃。结果 羟苯乙酯、硫柳汞和苯扎氯铵的峰面积与浓度的线性关系良好(r>0.999)，线性范围分别为：0.07~1.32，0.38~9.51，3.26~32.6 μg·mL^-1，加样回收率为99.0%~100.3%。结论 本方法灵敏，快速，准确，重复性好，可用于苄达赖氨酸滴眼液中抑菌剂的含量测定。

Abstract:

OBJECTIVE To establish an HPLC method for simultaneous determination of three bacteriostatic agents (ethylparaben, thimerosal, benzalkonium chloride) in bendazac lysine eye drops. METHODS The analysis was performed on Kromasil C₁₈ (4.6 mm×250 mm, 5 μm) with the mobile phase consisting of acetonitrile(A)-0.1% triethylamine(B)(adjusted to pH 3.0 by phosphoric acid) in gradient mode: 0-2 min, B 50%; 2-17 min, B 50%→90%; 17-29 min, B 90%; 29-30 min, B 90%→50%. The detection wavelength was 262 nm with injection volume of 20 μL and column temperature of 40 ℃. RESULTS ethylparaben, thimerosal and benzalkonium chloride showed good linearity(r>0.999) in the range of the test concentration of 0.07-1.32, 0.38-9.51, 3.26-32.6 μg·mL^-1. The average recoveries of the method were in 99.0%-100.3%. CONCLUSION The method is sensitive, rapid and accurate with good repeatability, which can be used for rapid screening and determination of the content of bacteriostatic agents in bendazac lysine eye drops.