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A kind of rt-hplc detection method of related substances of doxylamine succinate

A technology for the detection of doxylamine succinate and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of inability to separate the characteristic peaks of doxylamine succinate and related substances, and achieve simple sample pretreatment and high sample efficiency. The effect of ensuring quality with less dosage

Active Publication Date: 2018-06-29
NANJING GRITPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In order to solve the problem that the prior art cannot separate the characteristic peaks of doxylamine succinate and related substances, the invention provides a RT-HPLC detection method for related substances of doxylamine succinate, comprising the following steps:

Method used

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  • A kind of rt-hplc detection method of related substances of doxylamine succinate
  • A kind of rt-hplc detection method of related substances of doxylamine succinate
  • A kind of rt-hplc detection method of related substances of doxylamine succinate

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Embodiment 1

[0030] (1) Instrument and chromatographic conditions

[0031] High performance liquid chromatography: Agilent1260 high performance liquid chromatography system and workstation;

[0032] Chromatographic column: Agilent C8 250mm×4.6mm, 5μm;

[0033] Preparation of mobile phase: Take 3.4g of potassium dihydrogen phosphate, 1.5g of triethylamine hydrochloride, 1.5g of sodium dodecylsulfonate, add 650ml of water, stir to fully dissolve, add 300ml of acetonitrile, add 50ml of methanol, stir to make the solution Clarify, filter, and take the filtrate as the mobile phase; the flow rate is 1.0ml per minute, the detection wavelength is 262nm, and the column temperature is 40°C.

[0034] (2) Experimental steps

[0035] Take doxylamine succinate, impurity A (introduction of starting material), impurity B (intermediate impurity), impurity C (demethylation impurity), impurity D (starting material), impurity E (monooxidation impurity) respectively Appropriate amount, put in 10ml measuring...

Embodiment 2

[0038] (1) Instrument and chromatographic conditions

[0039] High performance liquid chromatography: Agilent1260 high performance liquid chromatography system and workstation;

[0040] Chromatographic column: Agilent C8 250mm×4.6mm, 5μm;

[0041] Prepare mobile phase: potassium dihydrogen phosphate 3.4g, triethylamine hydrochloride 1.5g, sodium dodecylsulfonate 1.5g, add water 700ml, stir to fully dissolve, add acetonitrile 295ml, add methanol 55ml, stir to clarify the solution , filtered, and the filtrate was taken as the mobile phase; the flow rate was 1.0ml per minute, the detection wavelength was 262nm, and the column temperature was 40°C.

[0042] (2) Experimental steps

[0043] Take doxylamine succinate, impurity A (introduction of starting material), impurity B (intermediate impurity), impurity C (demethylation impurity), impurity D (starting material), impurity E (monooxidation impurity) respectively Appropriate amount, put in 10ml measuring bottle, add 0.1M HCl to...

Embodiment 3

[0046] (1) Instrument and chromatographic conditions

[0047] High performance liquid chromatography: Agilent1260 high performance liquid chromatography system and workstation;

[0048] Chromatographic column: Agilent C8 250mm×4.6mm, 5μm;

[0049]Prepare potassium dihydrogen phosphate 3.4g, triethylamine hydrochloride 1.5g, sodium dodecylsulfonate 1.5g, add 600ml of water, stir to fully dissolve, add acetonitrile 305ml, add methanol 45ml, stir to clarify the solution, filter, Take the filtrate as the mobile phase; the flow rate is 1.0ml per minute, the detection wavelength is 262nm, and the column temperature is 40°C.

[0050] (2) Experimental steps

[0051] Take doxylamine succinate, impurity A (introduction of starting material), impurity B (intermediate impurity), impurity C (demethylation impurity), impurity D (starting material), impurity E (monooxidation impurity) respectively Appropriate amount, put in 10ml measuring bottle, add 0.1M HCl to dissolve and dilute to the...

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Abstract

The invention relates to the technical field of pharmaceutical analysis, in particular to a reversed-phase high-performance liquid chromatography detection method for related substances of doxylamine succinate and discloses an RT-HPLC detection method for the related substances of doxylamine succinate. The RT-HPLC detection method comprises the following steps of preparing an analyzing solution, setting chromatographic conditions and carrying out measurement on a machine. By means of the RT-HPLC detection method, various related impurities in a doxylamine succinate solution can be effectively measured, and separation of doxylamine succinate characteristic peaks and the related impurities in a spectrogram is especially achieved. Thus, it is ensured that the quality of products is controllable.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a reversed-phase high-performance liquid chromatography detection method for related substances of doxylamine succinate. Background technique [0002] The so-called "related substances" in drug analysis refer to the substances such as starting materials, reagents, intermediates, by-products and isomers brought in during the production of raw materials Special impurities such as degradation products, polymers or crystal transformations generated during storage and transportation. The type of related substances is closely related to the synthesis route and preparation process of the drug. Any change in any factor in the process of drug synthesis and preparation may lead to different types of related substances. Therefore, the detection and control process of related substances is relatively complicated. The detection of related substances is an important indicator for contro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89
CPCG01N30/89
Inventor 霍立茹张慧卢翔周洁张元元赵卿李战余秋阳
Owner NANJING GRITPHARMA CO LTD
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