A method for detecting related substances in drospirenone ethinylestradiol tablets (II)

Thirteen impurities in drospirenone ethinylestradiol tablets were separated and quantified by high performance liquid chromatography, overcoming the shortcomings of existing detection methods and achieving efficient and sensitive impurity separation and quantification, thus ensuring the stability and safety of the formulation.

CN122345673APending Publication Date: 2026-07-07CHINA RESOURCES ZIZHU PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
CHINA RESOURCES ZIZHU PHARMA
Filing Date
2026-05-08
Publication Date
2026-07-07

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Abstract

The present application relates to the field of pharmaceutical analysis method, specifically relates to a kind of detection method of related substance in drospirenone ethinylestradiol tablet (II).The method can simultaneously determine drospirenone ethinylestradiol tablet (II) drospirenone, ethinylestradiol and 13 kinds of related substances, method specificity is strong, sensitivity is high, suitable for drospirenone ethinylestradiol tablet (II) Process research, intermediate process control, finished product quality detection and stability research.
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