| 一种通用型滴眼液中抑菌剂硫柳汞HPLC含量测定方法的研究 |
| 投稿时间：2024-04-15 修订日期：2024-09-23 点此下载全文 |
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| 基金项目:国家药典委员会药品医疗器械审评审批制度改革专项课题（ZG2016-4-03） |
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| 中文摘要:目的 建立测定滴眼液中硫柳汞含量的HPLC方法，用于滴眼液中已知抑菌剂量的检查或未知抑菌剂量的筛查。方法 采用高效液相色谱法，资生堂MGII-C18色谱柱（4.6 mm×250 mm，5 μm），流动相为1%三乙胺（磷酸调节pH为3.0）-甲醇，梯度洗脱，柱温为40°C，检测波长为222 nm，流速为1 ml/min，进样体积20 μl。结果 硫柳汞在4.3～216.7 μg/ml之间呈良好的线性关系(r＞0.999)，平均回收率为102.1%，RSD为2.7%。结论 本法简便、准确、专属性强，可用于滴眼液中硫柳汞的定量测定。 |
| 中文关键词:HPLC 滴眼液 抑菌剂 硫柳汞 含量测定 |
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| Establish a generic method of HPLC to determine antimicrobial preservatives thimerosal in Eye Drops |
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| Abstract:Objective To establish a method for determining thimerosal compounds in eye drops by HPLC. Methods A gradient HPLC system was used in the quantitative analysis of thimerosal compounds on Shiseido MGII C18 column（4.6 mm×250 mm，5 μm）, using 1% triethylamine solution ( pH adjusted to 3.0 with phosphate) as mobile phase A, the methanol as mobile phase B , gradient elution, The column temperature was 40 ℃, the detection wavelength was 222 nm , the flow rate was 1 ml/min and the injection volume was 20 μl. Results The established method had good linearity within the concentration range of 4.3-216.7 μg/ml(r＞0.999) for thimerosal，with average recoveries was 102.1%, RSD2.7%. Conclusion The method is simple，accurate and specific for determination of thimerosal compound in eye drops. |
| keywords:HPLC Eye drop Antimicrobial preservatives Thimerosal Determination |
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