High performance liquid detection method of abiraterone acetate preparation

A technology of abiraterone acetate and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that cannot meet the requirements of capsule impurity separation and detection sensitivity, cannot be effectively separated, cannot be accurately quantified, and achieves practical Strong, reduced retention, good sensitivity and specificity
CN112964800AInactive Publication Date: 2021-06-15江苏万高药业股份有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
江苏万高药业股份有限公司
Publication Date
2021-06-15
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention belongs to the field of medicine quality control, and particularly relates to a high performance liquid chromatography detection method of an abiraterone acetate preparation. According to the method, octadecylsilane chemically bonded silica is adopted as a filler, a 0.1% (V / V) phosphoric acid solution is adopted as a mobile phase A, acetonitrile is adopted as a mobile phase B, gradient elution is carried out, and the detection wavelength is 254 nm. The method comprises the following steps: preparing an abiraterone acetate test sample solution from an abiraterone acetate test sample and ethanol, respectively preparing a contrast solution and a sensitivity solution, respectively injecting samples, and calculating by adopting a correction factor contrast method.The detection method overcomes the defects of auxiliary material interference and too strong retention of main components and impurities, can be used for rapidly detecting abiraterone acetate impurities and degradation products, is simple to operate, has high sensitivity and good specificity, and is convenient to control the product quality.
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Description

technical field

[0001] The invention relates to a high-efficiency liquid phase detection method for abiraterone acetate preparations, in particular to a detection method for abiraterone acetate capsules, belonging to the field of drug quality control. Background technique

[0002] Abiraterone Acetate is a prodrug of Abiraterone, a selective irreversible inhibitor of 17α-hydroxylase / C17,20-lyase (CYP17). The enzyme is expressed in testis and adrenal gland tissues and catalyzes the conversion of pregnene and nandrolone and progesterone to testosterone precursors, DHEA and androstenedione, respectively, through 17α hydroxylation and cleavage of C17,20 bonds. Abiraterone can inhibit the activity of CYP17 to prevent testosterone synthesis in testes, adrenal glands and tumors. Due to the possible introduction of residual raw materials and other related substances in the production process of Abiraterone Acetate Soft Capsules, degradation products may also be produced during the s...

Claims

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