Determination method of povidone k30 content by hplc

A determination method and technology of povidone, which are applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems such as the inability to specifically measure the content of povidone K30.
CN112684031BActive Publication Date: 2022-05-17东莞西典医药科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
东莞西典医药科技有限公司
Publication Date
2022-05-17

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Abstract

The invention discloses an HPLC determination method for povidone K30 content. In the determination method, a mixed solution of potassium nitrate-acetonitrile-water is used as a mobile phase, and molecular exclusion chromatography is used to determine the content of povidone K30 in a product to be tested. The method of the present application is simple, fast, accurate and sensitive, can accurately determine the content of povidone K30, can be applied to the reverse engineering research of povidone K30 in oral solid preparations, and is useful for generic drug development and consistency evaluation And bioequivalence studies provide supporting data to speed up the research and development process.
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Description

technical field

[0001] The invention relates to the technical field of detection of povidone content, in particular to an HPLC method for determining the content of povidone K30. Background technique

[0002] Povidone K30 (PVPK30) is widely used in medicine and is one of the three new pharmaceutical excipients advocated internationally. The most widely used is the binder of tablets and granules. PVP can also be used as a glidant for capsules, a detoxifier and lubricant for eye drops, a solubilizer for injections, a dispersant for liquid preparations, and a stabilizer for enzymes and heat-sensitive drugs. Povidone can also synthesize PVP-I disinfectant with iodine. PVP can also be used as a cryopreservative in medicine. There are hundreds of drugs using PVP products as excipients. The development and consistency evaluation of generic drugs and the exemption of bioequivalence experiments are all required to be consistent with the quality and curative effect of the original...

Claims

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