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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.

Active Publication Date: 2022-05-17
东莞西典医药科技有限公司
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  • Abstract
  • Description
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Problems solved by technology

As an important pharmaceutical excipient, the prior art only has the published application number 201610423183.7—the HPLC determination method of povidone content in povidone-iodine aqueous solution, which uses a C18 chromatographic column and an ultraviolet detector, which cannot be specifically determined The content of povidone K30 can only measure the total amount of povidone

Method used

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  • Determination method of povidone k30 content by hplc
  • Determination method of povidone k30 content by hplc
  • Determination method of povidone k30 content by hplc

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Embodiment 1

[0029] 1. Instruments and equipment:

[0030] Thermo Fisher High Performance Liquid Chromatography (Ultimate 3000); Phenomenon Chromatography Column (H19-165010); Chromeleon Chromatography Data Workstation, Mettler Electronic Balance (PL6001E / 02 and XS105DU).

[0031] 2. Test drug:

[0032] Povidone K30 (BASF, batch number: G71866PTO);

[0033] Ferrous succinate (Chengdu Aobang, batch number 190701);

[0034] Succinic acid (Chengdu Lier, batch number 171207);

[0035] Acetonitrile (HPLC pure, Thermo Fisher, batch number: 19888);

[0036] Potassium nitrate (Sinopharm, batch number: 20190716);

[0037] Calcium hydrogen phosphate (Sibaiquan, 3GB0037);

[0038] Corn starch (Anhui Shanhe, batch number: 171118);

[0039] Magnesium stearate (Shanghai Yunhong Chemical Co., Ltd., batch number C832520).

[0040] 3. Solution preparation:

[0041] Preparation of the mobile phase: Dissolve 10.1 g of potassium nitrate in 800 ml of water, and filter with a 0.45 μm aqueous microporous...

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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.

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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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 刘国宁
Owner 东莞西典医药科技有限公司
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