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目的:建立复方雌三醇阴道生物黏附膜中3组分含量的高效液相色谱分析方法。方法:以ODS-80Ts(4.6mm×150mm,5μm)为色谱柱,以0.05mol.L-1枸橼酸(三乙胺调pH至3.51)-甲醇(40∶60,V/V)为流动相,检测波长盐酸环丙沙星和醋酸地塞米松均为242nm,雌三醇为277nm。结果:盐酸环丙沙星、醋酸地塞米松和雌三醇分别在15.97～798.4mg.L-1,1.66～83.2mg.L-1,1.56～77.8mg.L-1范围内呈良好线性关系,盐酸环丙沙星的回归方程为Y=9.892 4X-16.048 6,r=0.999 9;醋酸地塞米松的回归方程为Y=36.867 3X+5.493 3,r=0.999 9;雌三醇的回归方程为Y=6.925 1X+1.937 9,r=0.999 9。测定方法的平均回收率:盐酸环丙沙星为99.67%,RSD为0.54%;醋酸地塞米松为98.54%,RSD为0.42%;雌三醇为98.44%,RSD为0.87%。结论:该方法简便易行,准确性好,可用于复方雌三醇阴道生物黏附膜的含量控制。
Objective: To establish a HPLC method for the determination of 3 components in compound estriol vaginal bioadhesive membrane. METHODS: ODS-80Ts (4.6mm × 150mm, 5μm) was used as the mobile phase and 0.05mol·L-1 citric acid (triethylamine adjusted to pH 3.51) -methanol (40:60, V / V) Phase, detection wavelength ciprofloxacin hydrochloride and dexamethasone acetate were 242nm, estriol 277nm. Results: Ciprofloxacin hydrochloride, dexamethasone acetate and estriol showed a good linear relationship in the range of 15.97 ~ 798.4mg.L-1, 1.66 ~ 83.2mg.L-1, 1.56 ~ 77.8mg.L-1, respectively , The regression equation of ciprofloxacin hydrochloride was Y = 9.892 4X-16.048 6, r = 0.999 9; the regression equation of dexamethasone acetate was Y = 36.867 3X + 5.493 3, r = 0.999 9; the regression equation of estriol Y = 6.925 1X + 1.937 9, r = 0.999 9. The average recoveries of the determination methods were 99.67% for ciprofloxacin hydrochloride, RSD 0.54%, dexamethasone acetate 98.54%, RSD 0.42%, estriol 98.44% and RSD 0.87%. Conclusion: The method is simple and easy to operate with good accuracy and can be used for the content control of vaginal bioadhesive membrane of compound estriol.