复方托吡卡胺滴眼液含量测定方法的改进

目的:建立同时测定复方托吡卡胺滴眼液中两组分含量的方法.方法:C18柱,以甲醇-0.03 mol·L-1辛烷磺酸钠溶液(1∶1)为流动相(用磷酸调节pH为3.0),检测波长263nm；柱温30℃；流速1.0 mL·min-1.结果:盐酸去氧肾上腺素在0.054 0～0.504 0 mg·mL-1范围内呈良好的线性关系(r=0.999 9)；托吡卡胺在0.05021 ～0.502 1 mg· mL-1范围内呈良好的线性关系(r =0.999 8).盐酸去氧肾上腺素的平均回收率为99.58％,RSD值为1.6％(n=9)；托吡卡胺的平均回收率为100.5％,RSD值为1.1％(n=9).结论:方法简便,分离度符合要求,结果准确可靠,可以用于复方托吡卡胺滴眼液的含量测定.

Determination Content of two Constituents in the Compound Tropicamide Phenylephrine Eye Drops by HPLC

Objective： To establish an HPLC method for determining phenylephrine hydrochloride and tropicamide in the compound tropieamide eye drops simultaneously. Methods： The HPLC was carried out with C18 column, the mobile phase was mixture of metha- nol-0. 03 mol · L-1 octane sulfonate sodium solution （ 1：1 ）, adjusting to pH 3.0 with phosphorus acid, detection wavelength was set at 263 nm; column temperature was 30 ℃ ; flow rate was 1.0 mL · min - 1. Results： The good linear relationship of phenylephrine hydrochloride within the range of 0. 054 0 -0. 504 0 mg · mL-1 （r =0. 999 9） and tropieamide within the range of 0. 050 21 -0. 502 1 mg · mL-1 （r =0. 999 8） are presented. The average recovery（n =9） of the Phenylephrine hydrochloride was 99. 58% （RSD = 1.6% ） , the average recovery （ n = 9） of the Tropicamide was 100.5% （ RSD = 1.1% ）. Conclusion： The method compared with the national standards is simple and quick and ean be used to determinate the compound tropieamide eye drops of phenylephrine hydroehloride and tropieamide.