摘要
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.
出处
《中国药事》
CAS
2014年第8期884-887,共4页
Chinese Pharmaceutical Affairs