依诺沙星滴眼液抑菌剂考察.PDFVIP

依诺沙星滴眼液抑菌剂考察  陈春晓，吴宏伟* ，李玲玲(厦门市食品药品质量检验研究院，福建 厦门 361012) 摘要：目的 建立测定依诺沙星滴眼液中抑菌剂硫柳汞、羟苯乙酯和苯扎溴铵的 HPLC 含量测定方法，并对这 3 种抑菌 剂的稳定性进行考察。方法 选用 C18 柱，以 1%三乙胺溶液(用磷酸调节 pH 值至 3.0)为流动相 A ，以甲醇为流动相 B ， 进行梯度洗脱；检测波长苯扎溴铵为 218 nm ，羟苯乙酯和硫柳汞为 262 nm ，进样量为 20 μL 。同时考察抑菌剂的稳定性。 结果 羟苯乙酯、硫柳汞和苯扎溴铵之间的分离度分别为 19.7，48.7 。硫柳汞在 9.1~151.4 μg·mL1、羟苯乙酯在 2.1~ 41.2 μg·mL1、苯扎溴铵在 21.8~218.0 μg·mL1 内均呈现良好的线性关系(r=0.999 ，1.000，0.999) ，其检出限分别为 1.4， 1.2，13.1 ng。在高温条件下，硫柳汞和羟苯乙酯含量均略有下降；在紫外光照条件下，硫柳汞含量下降明显；苯扎溴铵 几乎不受高温和紫外光照的影响。结论 该方法灵敏度高，能够有效评估滴眼液中抑菌剂的含量。 关键词：依诺沙星滴眼液；硫柳汞；羟苯乙酯；苯扎溴铵；含量测定；稳定性 中图分类号：R914.1 文献标志码：B 文章编号：1007-7693(2018)09-1280-04 DOI: 10.13748/ki.issn1007-7693.2018.09.002 引用本文：陈春晓, 吴宏伟, 李玲玲. 依诺沙星滴眼液抑菌剂考察 [J]. 中国现代应用药学, 2018, 35(9): 1280-1283. Investigation of Preservatives in Enoxacin Eye Drops * CHEN Chunxiao, WU Hongwei , LI Lingling(Xiamen Institution for Food and Drug Quality Control, Xiamen 361012, China) ABSTRACT: OBJECTIVE To establish a method for the determination of merthiolate, ethylparaben and benzalkonium bromide in enoxacin eye drops by HPLC, and to investigate the stability of these three preservatives. METHODS The analysis was performed on C 18 column, 1% triethylamine (adjusted to pH 3.0 with phosphoric acid) served as mobile phase A, methanol as mobile phase B by gradient elution. The detection wavelength was 218 nm (benzalkonium bromide) and 262 nm (merthiolate and ethylparaben) with the injection volume of 20 μL. The stability of preservatives was investigated. RESULTS The resolution between ethylparaben, merthiolate and benzalkonium bromide was 19.7 and 48.7. The standard curves of merthiolate, ethylparaben and benzalkonium bromide were linear in the range of 9.1151.4 μg·mL1, 2.141.2 μg·mL1 and 21.8218.0 μg·mL1 (r=0.999, 1.000, 0.999). The limit of