| 引用本文: | 杨梅,肖瑶,张亿,陈红.HPLC同时测定双氯芬酸钠滴眼液中3种抑菌剂的含量[J].中国现代应用药学,2019,36(10):1236-1239. |
| YANG Mei,XIAO Yao,ZHANG Yi,CHEN Hong.Simultaneous Determination of 3 Bacterial Inhibitors in Diclofenac Sodium Eye Drops by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(10):1236-1239. |
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| 摘要: |
| 目的 建立HPLC同时测定双氯芬酸钠滴眼液中羟苯乙酯、硫柳汞和苯扎氯铵含量的方法。方法 用十八烷基键合硅胶为填充剂，以1%三乙胺溶液（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；流速1.0 mL·min-1，柱温40℃，检测波长254 nm。结果 羟苯乙酯在20.58~205.8 μg·mL-1、硫柳汞在8.242~82.42 μg·mL-1、苯扎氯铵n-C12H25取代物在12.88~128.8 μg·mL-1、苯扎氯铵n-C14H29取代物在6.624~66.24 μg·mL-1内线性良好（r≥0.999 8），平均回收率为99.3%~102.5%（n=9）。结论 该方法简单、准确、重复性好，可用于控制双氯芬酸钠滴眼液中羟苯乙酯、硫柳汞和苯扎氯铵的含量。 |
| 关键词: 抑菌剂 双氯芬酸钠滴眼液 羟苯乙酯 硫柳汞 苯扎氯铵 含量测定 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.10.013 |
| 分类号:R917.101 |
| 基金项目: |
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| Simultaneous Determination of 3 Bacterial Inhibitors in Diclofenac Sodium Eye Drops by HPLC |
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YANG Mei, XIAO Yao, ZHANG Yi, CHEN Hong
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Chengdu Institute of Food and Drug Control, Chengdu 610045, China
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| Abstract: |
| BJECTIVE To establish a method for the simultaneous determination of ethyl hydroxybenzoate, thiomersal and benzalkonium chloride in diclofenac sodium eye drops by HPLC. METHODS The C18 column was used as analytical column, with 1% triethylamine solution(phosphoric acid adjusted pH to 3.0) as mobile phase A, and methanol as mobile phase B with gradient elution. The column temperature was kept at 40℃. The flow rate was 1.0 mL·min-1. The detection wavelength was set at 254 nm. RESULTS Between 20.58-205.8 μg·mL-1(ethyl hydroxybenzoate), 8.424-82.42 μg·mL-1(thiomersal), 12.88-128.8 μg·mL-1(benzalkonium chloride n-C12H25), 6.624-66.24 μg·mL-1(benzalkonium chloride n-C14H29), their linearities were good, with their recoveries were between 99.3%-102.5%(n=9). CONCLUSION The method is simple, accurate and reproducible. It can be used to control the content of ethyl hydroxybenzoate, thiomersal and benzalkonium chloride in diclofenac sodium eye drops. |
| Key words: bacterial inhibitor diclofenac sodium eye drops ethyl hydroxybenzoate thiomersal benzalkonium chloride content determination |
