Simultaneous Determination of Main Components in Estrogenic Hormone Drug Nilestriol Tablets and Diethylstilbestrol Tablets by HPLC / 中国药房
China Pharmacy
; (12): 469-472, 2019.
Article
in Zh
| WPRIM
| ID: wpr-817089
Responsible library:
WPRO
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.
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Index:
WPRIM
Language:
Zh
Journal:
China Pharmacy
Year:
2019
Type:
Article