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Abstract Objective: To establish high-performance liquid chromatography (HPLC) method for the detection of related substances in compound gestodene intravaginal ring. Methods: The separation and determination were accomplished on the HPLC with a column of Diamonsil C18 (250 mm ×4.6 mm，5μm) and UV detection at 239, 205nm for gestodene and ethinyloestradiol respectively．The mobile phase consisted of acetonitrile and water (50:50) at a flow rate of 1.0 ml/min. Results: Specificity test results showed that gestodene, ethinyloestradiol and related impurities, degradation products were well separated, while blank accessories had no interference for determination, Gestodene and ethinyloestradiol detection limits were 4 ng/ml and 5 ng/ml, The reproducibility was good for RSD were 1.6% and 1.3%. Conclusion: The method used for detection of related substances in compound gestodene intravaginal ring is easy to operate and has specificity, high sensitivity and good producibility.
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