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Method for detecting content of impurities in isoniazid or medicinal composition thereof

A technology of isoniazid and its composition, which is applied in the field of determination of the impurity content in the anti-tuberculosis drug isoniazid or its pharmaceutical composition, and can solve the problem of low specificity

Active Publication Date: 2017-10-10
SHENYANG HONGQI PHARMA
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Problems solved by technology

[0007] The disadvantage of the prior art is that it is not very specific, especially for the separation of possible degradation product Maillard impurities in the isoniazid composition

Method used

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  • Method for detecting content of impurities in isoniazid or medicinal composition thereof
  • Method for detecting content of impurities in isoniazid or medicinal composition thereof
  • Method for detecting content of impurities in isoniazid or medicinal composition thereof

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Embodiment 1

[0065] Step 1, preparation of impurity reference substance solution: accurately weigh the appropriate amount of isonicotinic acid and isonicotinamide reference substance, dissolve in water and quantitatively dilute to make a solution containing about 2.5 μg in each 1ml, as isonicotinic acid and isonicotinamide Reference substance solution;

[0066] Step 2, preparation of the test solution: take an appropriate amount of the test product, add water to dissolve isoniazid and dilute it to make a solution containing about 0.5 mg of isoniazid per 1 ml, filter, and take the subsequent filtrate as the test solution ;

[0067] Step 3, preparation of contrast solution: accurately measure 1.0ml of the test solution, put it in a 100ml measuring bottle, add water to quantitatively dilute to the mark, and use it as contrast solution;

[0068] Step 4, determination method: Precisely measure 10 μl each of the impurity reference solution, the test solution and the control solution, respective...

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Abstract

The invention relates to a method for detecting the content of impurities in isoniazid or a medicinal composition thereof. The method comprises the following steps: 1, preparing an impurity reference substance solution, namely precisely weighing a proper amount of isonicotinic acid and an isonicotinic acid reference substance, dissolving with water, and quantitatively diluting to serve as isonicotinic acid and the isonicotinic acid reference substance solution; 2, preparing a test substance solution, namely weighing a proper amount of a test substance, adding water to dissolve isoniazid, diluting, filtering and taking subsequent filtrate as a test substance solution; 3, preparing a reference solution, namely precisely weighing the test substance solution, and diluting for 100 times to serve as a reference solution; and 4, carrying out a detection method, namely precisely weighing 10mu l of the impurity reference substance solution, 10mu l of the test sample solution and 10mu l of the reference solution respectively, respectively injecting into a liquid chromatograph, recording a chromatogram map, and calculating contents of isonicotinic acid, pyrazinamide and other impurities by adopting a peak area method according to the chromatogram map.

Description

Technical field: [0001] The invention relates to a method for determining the content of impurities in the anti-tuberculosis drug isoniazid or its pharmaceutical composition. Background technique: [0002] Isoniazid combined with other anti-tuberculosis drugs is suitable for the treatment of various types of tuberculosis, including tuberculous meningitis and other mycobacterial infections. Isoniazid alone is suitable for the prevention of various types of tuberculosis. [0003] The prior art has reported a method for the determination of related substances in isoniazid by using high performance liquid chromatography, such as the following method, [0004] Chromatographic conditions: Octadecylsilane bonded silica gel as filler, 0.02mol / L sodium dihydrogen phosphate solution (adjust pH value to 6.0 with phosphoric acid)-methanol (85:15) as mobile phase, detection wavelength 262nm. The number of theoretical plates should not be less than 4000 based on the peak of isoniazid. ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/042
Inventor 李娟蒙娅杨晓泉朱丹张阳
Owner SHENYANG HONGQI PHARMA
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