| 田海燕,李智慧.HPLC法同时测定吡诺克辛钠滴眼液中不同抑菌剂的含量[J].中国药事,2017,(2):150-156 |
| HPLC法同时测定吡诺克辛钠滴眼液中不同抑菌剂的含量 |
| Simultaneous Determination of Content of Different Preservatives in Pirenoxine Sodium Eye Drops by HPLC |
| 投稿时间：2016-08-01 |
| DOI：10.16153/j.1002-7777.2017.02.007 |
| 中文关键词: 吡诺克辛钠滴眼液 抑菌剂测定 硫柳汞钠 羟苯甲酯 羟苯乙酯 羟苯丙酯 高效液相色谱 |
| 英文关键词: Pirenoxine sodium eye drops preservatives assag merthiolate sodium methylparaben ethylparaben propyl hydroxybenzoate HPLC |
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| 中文摘要: |
| 目的：建立同时测定吡诺克辛钠滴眼液中不同抑菌剂（硫柳汞钠、羟苯甲酯、羟苯乙酯、羟苯丙酯）含量的HPLC法。方法：采用C18色谱柱（4.6 mm×150 mm，5 μm），流动相为0.005 mol·L-1的醋酸铵溶液（每1000 mL中含三乙胺10 mL，用冰醋酸调节pH值至5.0±0.5）-乙腈（70：30），流速为1.0 mL·min-1，检测波长为256 nm，柱温为30℃。结果：硫柳汞钠、羟苯甲酯、羟苯乙酯和羟苯丙酯在各自的检测质量浓度范围内线性关系良好，r为0.9993~1.0000，检测限分别为2.3、0.4、0.7、1.1 ng；4种抑菌剂的平均回收率为100.4%~102.7%（RSD≤1.4，n=9）。结论：本文建立的方法结果准确可靠，可作为吡诺克辛钠滴眼液中不同抑菌剂的质量控制方法。 |
| 英文摘要: |
| Objective: To establish the method for simultaneous determination of content of different preservatives (merthiolate sodium, methylparaben, ethylparaben, propyl hydroxybenzoate) in Pirenoxine sodium eye drops by HPLC.Methods: The separation was performed on a C18 column (4.6 mm×150 mm, with ammonium acetate solution of 0.005 mol·L-1(every 1000 mL contained 10 mL triethylamine and pH was adjusted with glacial acetic acid to 5.0±0.5)-acetonitrile (70:30) as mobile phase at the flow rate of The detection wavelength was set at 256 nm and the column temperature was.Results: The calibration curves of merthiolate sodium, methylparaben, ethylparaben, and propyl hydroxybenzoate reflected good linearities (r=0.9993-1.0000). The detection limits were 2.3, 0.4, 0.7 and 1.1 ng. Average recoveries of 4 kinds of bacteriostatic agent were 100.4%-102.7%(RSD≤1.4, n=9).Conclusion: The established method is accurate and reliable, which is suitable for quality control of different preservatives in Pirenoxine sodium eye drops. |
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