氯霉素滴眼液中羟苯乙酯和硫柳汞含量的测定

Determination of Ethylparaben and Thimerosal in Chloramphenicol Eye Drops

目的建立测定氯霉素滴眼液中常用抑菌剂羟苯乙酯、硫柳汞的HPLC含量测定方法。方法羟苯乙酯采用DiamonsilC18色谱柱;流动相为0.1%庚烷磺酸钠溶液(0.1%庚烷磺酸钠溶液500mL与二甲基甲酰胺5mL、冰醋酸0.5mL,混匀)-乙腈(75∶25);流速:1.0mL·min-1;检测波长为272nm;柱温30℃;硫柳汞采用AgilentEclipseXDB-C18色谱柱;流动相:0.02mol·L-1乙酸铵-甲醇(70∶30);流速:1.0mL·min-1;检测波长为240nm,柱温20℃。结果羟苯乙酯在0.60～300μg·mL-1范围内与色谱峰面积呈良好的线性关系(r=0.9997),平均回收率在98.4%～99.9%之间,硫柳汞在0.50～500μg·mL-1范围内与色谱峰面积呈良好的线性关系(r=0.99999),平均回收率在97.65%～98.89%之间,RSD<0.5%。结论通过对市售不同生产单位的氯霉素滴眼液中羟苯乙酯、硫柳汞含量测定,证明方法灵敏、准确,专属性好,适用于检测氯霉素滴眼液中两种常用抑菌剂羟苯乙酯、硫柳汞的含量。

Objective To establish a quantitative analysis ot ethylparaben and mlmerosal in Chloramphenical Eye Drops by HPLC. Methods Ethylparaben is carried out on a Diamonsil C18 column; the mobile phase consisted of 0. 1 % sodium 1-heptanesulfonate （0. 10% sodiuml-heptanesulfonate 500mL, N, N-dimethylformamide 5mL, glaciao acetic acid 0.5mL） and acetonitrile （75 · 25） with the flow rate of 1.0mL · min^-1 ; the wavelength is 272nm; the temperature of column is 30℃. Thimerosal is carried out on a AgilentEcoipse XDB-C18 columm the mobile phase consisted of 0.02mol · L^-1 ammonium acetate and methanol （70 ： 30） with the flow rate of 1.0mL · min^-1; the wavelength is 240nm; the temperature of column is 20℃. Results Ethylparaben calibration curves is linear in range of 0. 60-300μg · mL^-1 （r=0. 9997）. The average recoveries is 98.4%-99.9%, RSD〈0.5%. Thimerosal calibration curves is in range of 0. 50-500μg · mL^-1. The average recoveries is 97.65-98.89%, RSD〈0.5%. Concousions Analysis the different samples of Chloramphenical Eye Drops, which manufactured by different production. The developed method is sensitive, accurate and reproducible, which is suitable for the determination of ethylparaben and thimerosal in Chloramphenical Eye Drops.