Determination of Related Substances in Dienestrol Tablets by HPLC / 中国药师

Objective:To determine the related substances in dienestrol tablets by HPLC. Methods:The separation was performed on a C18 column(250 mm × 4. 6 mm,5μm). The mobile phase consisted of methanol-acetonitrile(76∶24), the flow rate was set at 0. 8 ml·min-1 with the detection wavelength at 229 nm, and the sample size was 10 μl. Results:Under the established chromatographic conditions, the related substances and dienestrol were separated completely. The limit of detection was 2 ng. Conclusion:The method is simple, accurate, specific and sensitive in the determination of related substances in dienestrol tablets.