珍珠明目滴眼液中防腐剂尼泊金乙酯的含量测定

Determination of Preservative Ethylparaben in Pearl Eye Drops

目的 建立HPLC法测定珍珠明目滴眼液中防腐剂尼泊金乙酯的含量.方法 以十八烷基硅烷键合硅胶为填充剂;甲醇-水（78：22）为流动相;检测波长：254 nm;流速：1.0 mL· min^-1;柱温：35℃.结果 珍珠明目滴眼液中防腐剂尼泊金乙酯在96.10～961.0 ng范围内呈良好的线性关系（r=0.9999）,最小检出量为0.227 ng,平均回收率为99.06％（n=6）,RSD为0.27％.结论 本方法经方法学验证适用于珍珠明目滴眼液质量控制,可为该品种标准提升作参考.

Objective To develop an HPLC method for the determination of preservative ethylparaben in Pearl Eye Drops. Methods A C18 column （250 mm × 4.6 mm, 5 μm） was adopted with methanol - ultrapure water （78 ： 22） as the mobile phase. The detective wavelength was 254 nm, with the flow rate of 1.0 mL · min^-1 and the column temperature of 35 ℃. Results Ethylparaben was the only preservative in Pearl Eye Drops, within the range from 96.10-961.0 ng （r=0. 9999）. The result showed a good linearity between the injected amount and the peak area, with the limit of quantity of 0. 227 ng. The average recovery was 99.06G （n=6）, with the RSD of 0.27%. Conclusion It was indicated that the method was fast and accurate, which can be used to control the quality of Pearl Eye Drops and give a reference to the improvement of its standard.