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Detecting method for indole-3-carboxylic acid of impurities in tropisetron hydrochloride raw materials and preparations

A technology of tropisetron hydrochloride and indole formic acid, which is applied in the direction of measuring device, material separation, analysis of materials, etc., can solve the problem of inability to accurately quantify "3-indole formic acid", and achieves high accuracy and improved limit standards , the effect of increasing controllability

Active Publication Date: 2012-06-20
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the chromatographic conditions cannot accurately quantify "3-indolecarboxylic acid"
For the detection method of 3-indolecarboxylic acid in tropisetron hydrochloride preparations, only detection, there is no literature report at home and abroad

Method used

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  • Detecting method for indole-3-carboxylic acid of impurities in tropisetron hydrochloride raw materials and preparations
  • Detecting method for indole-3-carboxylic acid of impurities in tropisetron hydrochloride raw materials and preparations
  • Detecting method for indole-3-carboxylic acid of impurities in tropisetron hydrochloride raw materials and preparations

Examples

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Embodiment 1

[0041] The detection method of impurity 3-indolecarboxylic acid in described tropisetron hydrochloride raw material and preparation, comprises the steps:

[0042] (1) Get tropisetron hydrochloride raw material or preparation, dissolve and dilute to constant volume with initial mobile phase, prepare the solution that contains tropisetron hydrochloride 0.5mg in every 1ml, calculate with tropisetron, as need testing solution ;

[0043] (2) Get the 3-indolecarboxylic acid reference substance, add the initial mobile phase to dissolve and dilute to constant volume, and prepare a solution containing 0.5 μg in every 1ml as the reference substance solution;

[0044] (3) Get the need testing solution prepared in step (1) and each 50 μ l of the reference solution prepared in step (2) and inject high performance liquid chromatography respectively, carry out gradient elution and record chromatogram, need testing solution chromatogram picture see figure 1 , the chromatogram of the referen...

Embodiment 2

[0056] The detection method of impurity 3-indolecarboxylic acid in described tropisetron hydrochloride raw material and preparation, comprises the steps:

[0057](1) Get tropisetron hydrochloride raw material or preparation, dissolve and dilute to constant volume with initial mobile phase, prepare the solution that contains tropisetron hydrochloride 0.5mg in every 1ml, take tropisetron as the test solution ;

[0058] (2) Get the 3-indolecarboxylic acid reference substance, add the initial mobile phase to dissolve and dilute to constant volume, and prepare a solution containing 0.5 μg in every 1ml as the reference substance solution;

[0059] (3) Get the need testing solution prepared in the step (1) and each 50 μ l of the reference solution prepared in the step (2) and inject into the high performance liquid chromatograph respectively, carry out gradient elution and record the chromatogram, need testing solution chromatogram picture see figure 2 ;

[0060] in:

[0061] Th...

Embodiment 3

[0071] The detection method of impurity 3-indolecarboxylic acid in described tropisetron hydrochloride raw material and preparation, comprises the steps:

[0072] (1) Get tropisetron hydrochloride raw material or preparation, dissolve and dilute to constant volume with initial mobile phase, prepare the solution that contains tropisetron hydrochloride 0.5mg in every 1ml, take tropisetron as the test solution ;

[0073] (2) Get the 3-indolecarboxylic acid reference substance, add the initial mobile phase to dissolve and dilute to constant volume, and prepare a solution containing 0.5 μg in every 1ml as the reference substance solution;

[0074] (3) Get the need testing solution prepared in the step (1) and each 50 μ l of the reference solution prepared in the step (2) and inject into the high performance liquid chromatograph respectively, carry out gradient elution and record the chromatogram, need testing solution chromatogram picture see Figure 8 , the chromatogram of the r...

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Abstract

The invention relates to a detecting method for indole-3-carboxylic acid, in particular to a detecting method for indole-3-carboxylic acid of impurities in tropisetron hydrochloride raw materials and preparations. The detecting method includes the steps: (1) taking the tropisetron hydrochloride raw materials or preparations, performing dissolving and diluting to realize constant volume by means of initial flowing phase, preparing liquor containing 0.5mg of tropisetron hydrochloride per milliliter, and using the liquor as sample liquor by tropisetron; (2) taking indole-3-carboxylic acid reference substances, performing dissolving and diluting to realize constant volume by means of initial flowing phase, preparing liquor containing 0.5mug of indole-3-carboxylic acid per milliliter, and using the liquor as reference substance liquor; and (3) respectively filling 50mul of sample liquor prepared in the step (1) and 50mul of reference substance liquor prepared in the step (2) into a high performance liquid chromatograph for gradient elution. The detecting method has the advantages of high specificity, accuracy in quantification, high sensitivity and stability, and the limit of detectingdrug quality is improved to a high standard.

Description

technical field [0001] The invention relates to a detection method for 3-indolecarboxylic acid, in particular to a detection method for impurity 3-indolecarboxylic acid in tropisetron hydrochloride raw materials and preparations. Background technique [0002] Tropisetron hydrochloride is a highly selective 5-HT receptor antagonist, which is suitable for the prevention and treatment of nausea and vomiting caused by cancer chemotherapy, radiotherapy and surgery. Its structural formula is [0003] [0004] The chemical name is endo-1H-indole-3-carboxylic acid-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester hydrochloride. In the process of synthesizing this compound, 3-indolecarboxylic acid is used as the starting substrate to synthesize tropisetron hydrochloride through chemical reaction, so the purity and quality of the drug may be affected due to incomplete reaction, which needs to be checked. The structural formula of 3-indolecarboxylic acid is: [0005] [0006] For the ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 李洁于黎鑫刘绪贵于海云牛海岗高希波
Owner SHANDONG QIDU PHARMA
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