Dextromethorphan hydrobromide related substance detection method

A technology of dextromethorphan hydrobromide and its detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that the separation degree cannot meet the requirements, and cannot meet the simultaneous determination of five impurities, etc.

Pending Publication Date: 2022-05-27
SHIJIAZHUANG YILING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] From the above spectrum, it can be seen that the resolution of related substances of dextromethorphan cannot meet the requirements by using the existing technology, so the purpose of simultaneous determination of five impurities cannot be met.

Method used

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  • Dextromethorphan hydrobromide related substance detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] 1. Experimental part

[0092] 1.1 Instruments, reagents and materials

[0093] Waters e2695 high performance liquid chromatograph (Empower chromatography workstation); S210 pH meter (Mettler), XPE 105 electronic analytical balance (Mettler).

[0094] Sodium dioctyl sulfosuccinate (chemically pure, 96% pure, 97% pure, 99% pure and 99.0% pure) were purchased from Sinopharm Chemical Reagent Co., Ltd., Shandong West Asia Chemical Co., Ltd., Bailingwei and Sigma- Aldrich Company; glacial acetic acid (analytical grade) was purchased from Tianjin Damao; acetonitrile (chromatographic grade) was purchased from Merck Company, Germany; sodium nitrate and phosphoric acid (analytical grade) were purchased from Tianjin Comeo Co., Ltd.

[0095] Dextromethorphan hydrobromide impurity I, impurity II, impurity III and impurity IV reference substance were purchased from LGC in England; Dextromethorphan hydrobromide impurity D reference substance was purchased from TRC in Canada.

[0096...

Embodiment 2

[0104] 1. Experimental part

[0105] 1.1 Instruments, reagents and materials

[0106] Waters e2695 high performance liquid chromatograph (Empower chromatography workstation); S210 pH meter (Mettler), XPE 105 electronic analytical balance (Mettler).

[0107] Sodium dioctyl sulfosuccinate (chemically pure, 96% pure, 97% pure, 99% pure and 99.0% pure) were purchased from Sinopharm Chemical Reagent Co., Ltd., Shandong West Asia Chemical Co., Ltd., Bailingwei and Sigma- Aldrich Company; glacial acetic acid (analytical grade) was purchased from Tianjin Damao; acetonitrile (chromatographic grade) was purchased from Merck Company, Germany; sodium nitrate and phosphoric acid (analytical grade) were purchased from Tianjin Comeo Co., Ltd.

[0108] Dextromethorphan hydrobromide impurity I, impurity II, impurity III and impurity IV reference substance were purchased from LGC in England; Dextromethorphan hydrobromide impurity D reference substance was purchased from TRC in Canada.

[0109...

Embodiment 3

[0117] 1. Experimental part

[0118] 1.1 Instruments, reagents and materials

[0119] Waters e2695 high performance liquid chromatograph (Empower chromatography workstation); S210 pH meter (Mettler), XPE 105 electronic analytical balance (Mettler).

[0120] Sodium dioctyl sulfosuccinate (chemically pure, 96% pure, 97% pure, 99% pure and 99.0% pure) were purchased from Sinopharm Chemical Reagent Co., Ltd., Shandong West Asia Chemical Co., Ltd., Bailingwei and Sigma- Aldrich Company; glacial acetic acid (analytical grade) was purchased from Tianjin Damao; acetonitrile (chromatographic grade) was purchased from Merck Company, Germany; sodium nitrate and phosphoric acid (analytical grade) were purchased from Tianjin Comeo Co., Ltd.

[0121] Dextromethorphan hydrobromide impurity I, impurity II, impurity III and impurity IV reference substance were purchased from LGC in England; Dextromethorphan hydrobromide impurity D reference substance was purchased from TRC in Canada.

[0122...

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Abstract

The invention relates to a dextromethorphan hydrobromide related substance detection method, which can be used for simultaneously detecting five impurities and accurately determining the relative retention time and correction factor of each known impurity. The method is short in separation time, good in separation degree, low in quantification limit and accurate in result, and related substances in dextromethorphan hydrobromide can be effectively detected.

Description

technical field [0001] The invention relates to a quality control method for dextromethorphan hydrobromide, in particular to a method for detecting a related substance of dextromethorphan hydrobromide. Background technique [0002] Dextromethorphan Hydrobromide (DM) was synthesized by HoffmanRoche of Switzerland in the 1950s by modifying the structure of morphine. Its levorotatory compound has analgesic effect, and DM is a dextrorotatory morphinan derivative. It has obvious antitussive effect without analgesic effect, so it is also known as dextromethorphan. [0003] DM is white or off-white crystalline powder, odorless, easily soluble in ethanol, soluble in chloroform, slightly soluble in water, insoluble in ether, its molecular formula is C 18 H 25 NO•HBr•H 2 O, the chemical name is 3-methoxy-17-methyl-(9α,13α,14α)-morphinan hydrobromide monohydrate, the structural formula is as follows: [0004] [0005] There are 6 known impurities in the quality standard of dextr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 贾振华吴相君高翠华王展梁世如李松石静媛武玉杰
Owner SHIJIAZHUANG YILING PHARMA
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