| 王彩媚,伍伟聪,王淼,陈英.HPLC法测定氧氟沙星滴眼液中抑菌剂的含量[J].中国药品标准,2018,19(5):394-402 |
| HPLC法测定氧氟沙星滴眼液中抑菌剂的含量 |
| Determinations of the preservatives in ofloxacin eye drops by HPLC |
| 投稿时间：2018-05-16 修订日期：2018-09-26 |
| DOI： |
| 中文关键词: 羟苯甲酯 羟苯乙酯 羟苯丙酯 苯扎溴铵 苯扎氯铵n-C12H25取代同系物 氧氟沙星滴眼液 抑菌剂含量 |
| 英文关键词: Methylparaben Ethylparaben Propylparaben BenzalkoniumBromide Benzalkoniumchloride ofloxacin eye drops content determination |
| 基金项目: |
|
| 摘要点击次数: 598 |
| 全文下载次数: 0 |
| 中文摘要: |
| 摘要：目的 建立测定氧氟沙星滴眼液中羟苯甲酯、羟苯乙酯、羟苯丙酯、苯扎溴铵或苯扎氯铵的高效液相色谱法。方法 : 采用资生堂 ACR -C18 （250mm×4.6mm，5μm）色谱柱，以1%三乙胺溶液（用磷酸调节pH值至3.0）为流动相A，甲醇为流动相B进行梯度洗脱，检测波长为262nm。结果: 羟苯甲酯、羟苯乙酯、羟苯丙酯线性范围均为1~20μg·mL-1（r=1.0000），苯扎溴铵或苯扎氯铵n-C12H25取代同系物的线性范围均为10~200μg·mL-1（r=1.0000）；平均加样回收率（n=9）分别为99.5%（RSD=0.5%）；100.3%（RSD=0.4%）； 100.2%（RSD=0.4%）；98.9%（RSD=0.8%）；98.1%（RSD=0.5%）。按拟定方法分别对13个企业34个批次样品进行筛查分析，其中羟苯乙酯使用浓度为0.2~0.3mg·mL-1，苯扎溴铵使用浓度为0.1~0.2mg·mL-1，苯扎氯铵使用浓度为0.1mg·mL-1。结论: 本法测定氧氟沙星滴眼液中羟苯甲酯、羟苯乙酯、羟苯丙酯、苯扎溴铵或苯扎氯铵n-C12H25取代同系物准确、可靠、重现性好，[此句不通顺]可作为氧氟沙星滴眼液中羟苯甲酯、羟苯乙酯、羟苯丙酯、苯扎溴铵或苯扎氯铵n-C12H25取代同系物的定量分析方法。 |
| 英文摘要: |
| ABSTRACT: to develop an HPLC method for the simultaneous determination of Methylparaben、Ethylparaben、Propylparaben、BenzalkoniumBromide and Benzalkoniumchloride n-C12H25replace homologue in ofloxacin eye drops by HPLC .Methods: The sample was separated on SHISEDO ACR -C18 （250mm×4.6mm，5μm）with a mobile phase consisting of 0.1%triethylamine (pH3.0)(A)- methanol（B）in the gradient elution ,the detection wavelength was 262nm.Results: The calibration curves were linear within the range of 1-20μg·mL-1（r=1.0000）for parabens，10-200μg·mL-1（r=1.0000）for Benzyldodecyldime or Benzalkoniumchloride n-C12H25replace homologue, Respectively therecoveries (n=9)ofwere 99.5%（RSD=0.5%）；100.3%（RSD=0.4%）； 100.2%（RSD=0.4%）；98.9%（RSD=0.8%）；98.1%（RSD=0.5%）. According to the method, 34 batch samples of 13 enterprises were screened and analyzed. The concentration of ethylparaben was 0.2~0.3mg·mL-1, the use concentration of benzalkonium bromide was 0.1~0.2mg·mL-1, and the concentration of benzalkonium chloride was 0.1mg·mL-1. Conclusion:The method is simple,accurate and reproducible for simultaneous determination of Methylparaben,Ethylparaben,Propylparaben,BenzalkoniumBromide and Benzalkoniumchloride n-C12H25replace homologue . |
|
查看/发表评论 下载PDF阅读器 |
| 关闭 |