RP-HPLC法测定复方托吡卡胺滴眼液中盐酸去氧肾上腺素与托吡卡胺两组分含量

目的测定复方托吡卡胺滴眼液中盐酸去氧肾上腺素和托吡卡胺两组分的含量。方法用RP HPLC法,色谱柱:Inertsil C8柱(150 mm×4.6 mm,5μm);流动相:甲醇0.01 mol.L-1辛基磺酸钠溶液(体积比为1∶1,用磷酸调pH=3.00);检测波长:263 nm;柱温:30℃;流速:1 mL.min-1。结果盐酸去氧肾上腺素和托吡卡胺的线性范围分别为50.4~504.0 mg.L-1、48.8~487.6 mg.L-1;r值分别为0.999 7、0.999 8;盐酸去氧肾上腺素平均回收率为100.1%,RSD为0.45%;托吡卡胺平均回收率为99.74%,RSD为0.20%。结论该方法与国家标准相比简单、快捷,回收率和重复性良好,其线性、重复性、回收率均符合《中华人民共和国药典》的有关规定,可作为复方托吡卡胺滴眼液质量评价的方法。

Determination of the contents of phenylphrine hydrochloride and tropicamide in compound tropicamide eye drops by RP-HPLC

Objective To develop a method for simultaneous determination of the contents of phenylephrine hydrochloride and tropicamide in compound tropicamide eye drops by RP-HPLC.Methods Chromatography was performed using a Inertsil C_8(150 mm×4.6 mm,5 μm)column with mobile phase consisting of a mixture of methanol0.01 mol·L~(-1) 1-octanesulfonic acid sodium salt solution(pH=3.00 with phosphoric acid,(V∶V=)(1∶1)).The monitoring wavelength was set at 263 nm.The column temperature was 30 ℃ and the flow rate was(1 mL·min~(-1)).Results A good linearity was found in the range of 50.4-504.0 mg·L~(-1) and 48.8-(487.6 mg·L~(-1)) for phenylephrine hydrochloride(r=0.999 7)and tropicamide(r=0.999 8),respectively.The average recoveries was 100.1%(RSD=0.45%)and 99.74%(RSD=0.20%)for phenylephrine hydrochloride and tropicamide,respectively.Conclusions The method is simple,rapid and with satisfactory recoveries and good reproducibilities.It can be used to control the quality of compound tropicamide eye drops.