Determination method of dextromethorphan hydrobromide related substances

A technology of dextromethorphan hydrobromide and related substances, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of poor reproducibility of detection methods, unstable peak time, long analysis time, etc., and achieve convenient The effect of quality control, cost reduction, and improvement of analytical efficiency

Active Publication Date: 2022-04-12
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a method for determining related substances of dextromethorphan hydrobromide. The method adopts an ion-exchange chromatography system for analysis, which improves the long analysis time of the original method, poor reproducibility of the detection method, unstable peak time, and reagent consumption. Big problems

Method used

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  • Determination method of dextromethorphan hydrobromide related substances
  • Determination method of dextromethorphan hydrobromide related substances
  • Determination method of dextromethorphan hydrobromide related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] (1) Prepare the solution:

[0021] Diluent: acetonitrile / water (1:1)

[0022] The test solution: Take an appropriate amount of sample and dilute it with a diluent to obtain a 1.5mg / ml solution.

[0023] Reference substance solution: take appropriate amounts of dextromethorphan hydrobromide and reference substances of dextromethorphan hydrobromide impurities A, B, C, and D, place them in the same measuring bottle, add diluent to dilute each impurity to 7.5 μg / ml The solution.

[0024] Chromatographic conditions:

[0025] Chromatographic column: Comixsil RP-100 3.0×100mm, 3μm or a chromatographic column with equivalent performance

[0026] Mobile phase: 0.1M ammonium phosphate solution (pH6.5)-acetonitrile (55:45) (V / V), the elution method is isocratic elution

[0027] Detection wavelength: 280nm, column temperature: room temperature, flow rate: 0.6ml / min, running time: 30min;

[0028] (2) Determination method:

[0029] After the system was stabilized, the blank sol...

Embodiment 2

[0039] Example 2: Specificity

[0040] Take the diluent as a blank solution, and prepare impurity reference substance stock solution: get dextromethorphan hydrobromide impurity A, B, C, D, each appropriate amount of dextromethorphan hydrobromide reference substance, place respectively in a measuring bottle, add The diluent is diluted to 0.15 mg / ml of the impurity reference substance stock solution; preparation of the reference substance solution: accurately measure an appropriate amount of the reference substance stock solution, add the diluent to dissolve and dilute to a solution of 7.5 μg / ml to obtain the reference substance solution; Prepare the test solution: Accurately weigh about 30 mg of dextromethorphan hydrobromide, put it in a 20ml measuring bottle, add diluent to dissolve and dilute to the mark, shake well, that is the test solution; prepare the system applicability solution: precision Weigh about 30 mg of dextromethorphan hydrobromide reference substance, put it in...

Embodiment 3

[0043] Embodiment 3: limit of detection, limit of quantitation and linearity test

[0044] Precisely measure the appropriate amount of each reference substance stock solution, put it in the same measuring bottle, and dilute it with diluent so that each 1 ml contains dextromethorphan hydrobromide and dextromethorphan hydrobromide impurities A, B, C, D control The product is about 0.75, 6, 7.5, 12, 15 μg of a series of mixed solutions. After the system is stable, the detection is carried out according to the chromatographic conditions of Example 1, and the mass concentration C (μg / ml) is measured with the peak area A as the ordinate. Linear regression, the slope of each compound corresponding to the linear regression equation is as follows:

[0045]

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, particularly relates to a determination method of dextromethorphan hydrobromide related substances, and provides a convenient, efficient and accurate detection method for solving the problem of detection of the dextromethorphan hydrobromide related substances, and the method can detect the dextromethorphan hydrobromide related substances, so that the medication safety is effectively guaranteed, and the detection cost is reduced. The method is convenient, efficient and accurate, completely conforms to the guidance principle verified by methods in Chinese pharmacopoeia in the aspects of system applicability, repeatability, specificity and accuracy, and can be used for quality control of dextromethorphan hydrobromide.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for determining related substances of dextromethorphan hydrobromide. Background technique [0002] The chemical name of dextromethorphan hydrobromide is 3-methoxy-17-methyl-(9α, 13α, 14α)-morphinan hydrobromide monohydrate, and its structural formula is: , is the dextro-isomer of morphine-like morphan methyl ether, exerts a central antitussive effect by inhibiting the medullary cough center, is a non-addictive central antitussive, and its cough frequency suppression effect is similar to that of codeine, The inhibitory effect on the intensity of cough is better than that of codeine. Although its structure is similar to morphine, it has no analgesic effect, and the therapeutic dose does not inhibit breathing. It has no tolerance for long-term use and has low toxicity. [0003] The impurities and structures of related substances of dextromethorphan hydrobromide are ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/96
Inventor 吴晓斐姜春来周理英谢岳庭谢斌谢立
Owner 珠海润都制药股份有限公司
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