Simultaneous Determination of Main Components in Estrogenic Hormone Drug Nilestriol Tablets and Diethylstilbestrol Tablets by HPLC / 中国药房

ABSTRACT

OBJECTIVE： To establish the method for simultaneous determination of main drug contents in Nilestriol tablet and  Diethylstilbestrol tablet. METHODS： HPLC method was adopted. The determination was performed on Waters Symmetry C18 column with mobile phase consisted of 0.02 mol/L ammonium acetate water solution-acetonitrile （40 ∶ 60，V/V） at a flow rate of 1.0 mL/min. The detection wavelength was set at 280 nm， and column temperature was 35 ℃. The sample size was 20 μL. RESULTS： The linear range of nilestriol and diethylstilbestrol were 0.01-0.5 mg/mL （r＝0.999 9）； the limits of quantitation were 187 and 192 ng/mL， and the limits of detection were 56 and 58 ng/mL. RSDs of precision， stability and reproducibility tests were all lower than 1％ （n＝6）. The recoveries of them were 99.13％-100.80％（RSD＝0.52％，n＝9） and 99.20％-100.90％（RSD＝0.58％， n＝9）. CONCLUSIONS： The method is more sensitive and reproducible， and suitable for simultaneous determination of nilestriol content in estrogenic hormone drug Nilestriol tablets and diethylstilbestrol content in Diethylstilbestrol tablets.