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Method for measuring relative material of sodium divalproate

A technology of divalproex sodium and its determination method, which is applied in the field of drug detection, can solve problems such as unspecified substance inspection items and limits, clinical drug safety threats, etc., and achieve the effects of strong specificity, high sensitivity, and accurate detection

Inactive Publication Date: 2009-03-25
陕西天森药物研究开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, divalproex sodium that has been marketed at home and abroad does not specify the inspection items and limits of relevant substances in the quality standards, which poses a potential threat to the safety of clinical medication

Method used

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  • Method for measuring relative material of sodium divalproate
  • Method for measuring relative material of sodium divalproate
  • Method for measuring relative material of sodium divalproate

Examples

Experimental program
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preparation example Construction

[0075] The preparation method of the divalproex sodium sample mainly includes the screening of two substances: the acid for acidifying the sample, and the organic solvent for extracting valproic acid. Taking the content of divalproex sodium, the measured amount of related substances and the separation situation in the determination process of related substances as investigation indicators, acid and organic solvents were screened and studied, as shown in Table 4:

[0076] Chromatographic column: DB-WAX capillary column 30m*0.25mm*0.25μm; inlet temperature: 260°C; column temperature: 145°C; carrier gas: helium.

[0077] Sample preparation: Take about 2g of divalproex sodium, add 50ml of water, heat to dissolve, let cool, add 1ml of acid, add 15ml of organic solvent, shake, and let it stand to separate layers. The organic solvent layer was taken, evaporated to dryness, and the remaining liquid was tested for diallyl acetic acid.

[0078] Table 4 Determination of acids and organi...

Embodiment 1

[0109] (1) Chromatographic conditions

[0110] AE·PEG-20M capillary column 30m*0.25mm*0.25μm.

[0111] Injection port temperature: 240°C; column temperature: 130°C; carrier gas: hydrogen.

[0112] (2) Sample preparation

[0113] Take about 1g of divalproex sodium, add 30ml of water, heat to dissolve, let it cool, add 3ml of dilute hydrochloric acid, add 10ml of cyclohexane, shake, let it stand to make layers. Take the cyclohexane layer, evaporate it to dryness, and leave a residual liquid.

[0114] (3) Determination method

[0115] Precisely measure 0.1 μl of the residual liquid, inject it into a gas chromatograph, and record the chromatogram up to twice the retention time of the main component peak. If there are impurity peaks in the spectrogram of the test product, the sum of the areas of each impurity peak must not exceed 3% of the total area.

Embodiment 2

[0117] (1) Chromatographic conditions

[0118] DB-WAX capillary column 30m*0.25mm*0.25μm.

[0119] Injection port temperature: 220°C; column temperature: 150°C; carrier gas: nitrogen.

[0120] (2) Sample preparation

[0121] Take about 5g of divalproex sodium, add 100ml of water, heat to dissolve, let cool, add 2.5ml of phosphoric acid solution, add 35ml of petroleum ether, shake, let stand to make layers. Take petroleum ether, evaporate to dryness, remaining liquid.

[0122] (3) Determination method

[0123] Precisely measure 0.1 μl of the residual liquid, inject it into a gas chromatograph, and record the chromatogram up to twice the retention time of the main component peak. If there are impurity peaks in the spectrogram, the sum of the areas of each impurity peak shall not exceed 3% of the total area.

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Abstract

The invention discloses a method for mensurating relevant substances in sodium di-vedproate, The method comprises the following steps: sodium di-vedproate in a solid state is converted into valproic acid in a liquid state; a sodium di-vedproate sample is prepared; and according to contrast substances of butyric acid, valeric acid, diallyl acetic acid and (R,S)-2-isopropyl valerate, the relevant substances in the sodium di-vedproate are detected by a gas chromatograph instrument. The method can carry out relevant substances inspection on the sodium di-vedproate which exists in tablet dosages, capsule dosages, granular dosages, oral liquid dosages, needle dosages, film dosages, aerosol dosages or injection dosages and other dosages of a slow-release type, a controlled-release type and a common type, improve the quality standard of the prior sodium di-vedproate, and provide evidence for instituting a mensuration standard for the relevant substances of the sodium di-vedproate.

Description

technical field [0001] The invention relates to a detection method of medicines, in particular to a method for determination of related substances in divalproex sodium, and the method provides a basis for formulating the determination standard of divalproex sodium in my country. Background of the invention [0002] Divalproex sodium is a psychiatric drug listed in the United States, and it is a first-line drug used in the treatment of epilepsy, adult migraine and bipolar disorder. [0003] At present, divalproex sodium that has been marketed at home and abroad does not specify the inspection items and limits of relevant substances in the quality standards, which poses a potential threat to the safety of clinical medication. Therefore, in order to strictly control the quality of drugs and ensure the safety and effectiveness of its clinical medication, relevant substance inspections should be carried out for divalproex sodium to improve the existing quality standards of divalp...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 毛幼桦
Owner 陕西天森药物研究开发有限公司
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