胶束毛细管电动色谱法同时测定复方托吡卡胺滴眼液中盐酸去氧肾上腺素、托吡卡胺和羟苯乙酯

Simultaneous determination of phenylephrine hydrochloride,tropicamide and ethylparaben in compound tropicamide eye drops by micellar capillary electrokinetic chromatography

使用高精度定量毛细管电泳仪,建立胶束毛细管电动色谱法测定复方托吡卡胺滴眼液中盐酸去氧肾上腺素、托吡卡胺和羟苯乙酯含量的方法。采用带有隔离槽的石英毛细管柱(总长65 cm,有效长45 cm,内径75μm),电泳缓冲液为5 mmol/L硼砂-20 mmol/L十二烷基硫酸钠(pH 9.55),分离电压-15 kV,检测波长210 nm,柱温20℃。结果表明,3种成分分离效果良好,日内相对标准偏差为1.0%~1.6%,盐酸去氧肾上腺素、托吡卡胺和羟苯乙酯的浓度分别在0.046~0.51 mg/mL,0.043~0.62 mg/mL,0.027~0.11 mg/mL范围内与峰面积的线性相关系数(R2)为0.9989,0.9987和0.9989,3种成分的检出限分别为3.4,3.2和1.8μg/mL,平均回收率均在95.9%~99.6%范围内。该方法适用于复方托吡卡胺滴眼液中盐酸去氧肾上腺素、托吡卡胺和羟苯乙酯3种成分的同时测定。

Micellar capillary electrokinetic chromatography method was established to simultaneously determine the contents of phenylephrine hydrochloride,tropicamide and ethyl paraben in compound tropicamide eye drops.A quartz capillary column with isolation tank(total length 65 cm,effective length 45 cm,inner diameter 75 μm)was used with electrophoresis buffer of 5 mmol/L borax-20 mmol/L SDS(pH 9.55),separation voltage of-15 kV,detection wavelength of 210 nm,and column temperature of 20℃. The results showed the separation of the three components was good and their intra-day relative standard deviations were 1.0%-1.6%. The correlation coefficients(R~2)of linear relationships between the peak area and concentrations of phenylephrine hydrochloride(0.046-0.51 mg/mL),tropicamide(0.043-0.62 mg/mL)and ethyl paraben(0.027-0.11 mg/mL)were 0.9989,0.9987,and 0.9989,and their detection limits were 3.4,3.2,and 1.8 μg/mL,respectively. Their average recoveries were all in the range of 95.9%-99.6%. The method was suitable for the simultaneous determination of phenylephrine hydrochloride,tropicamide and ethyl paraben in compound tropecaramide eye drops.