Method for detecting content of dextromethorphan hydrobromide quinidine sulfate capsules

A technology for dextromethorphan hydrobromide and quinidine sulfate, which is applied in the field of detection of the content of dextromethorphan hydrobromide and quinidine sulfate capsules

Active Publication Date: 2021-11-30
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

[0003] Most of the currently disclosed documents are the detection method of dextromethorphan hydrobromide or quinidine sulfate, and there is no detection method for the content of dextromethorphan hydrobromide quinidine sulfate preparation disclosed in any document. The present invention discloses hydrobromic acid for the first time. The detection method for the content of dextromethorphan quinidine sulfate capsules provides a convenient, efficient and accurate detection method for solving the detection problem of the content of dextromethorphan quinidine sulfate capsules, which can detect hydrogen bromide The content of dextromethorphan quinidine sulfate capsule content, thereby effectively guaranteeing medication safety, facilitates the quality control of dextromethorphan hydrobromide quinidine sulfate capsule

Method used

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  • Method for detecting content of dextromethorphan hydrobromide quinidine sulfate capsules
  • Method for detecting content of dextromethorphan hydrobromide quinidine sulfate capsules
  • Method for detecting content of dextromethorphan hydrobromide quinidine sulfate capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] (1) Prepare the solution:

[0056] Blank solution: mobile phase A.

[0057] Reference substance solution: Take about 20 mg of dextromethorphan hydrobromide reference substance and about 10 mg of quinidine sulfate reference substance respectively, accurately weigh them, put them in the same 100ml measuring bottle, add mobile phase A and sonicate for 2 minutes to dissolve and dilute to the mark , shake well. (Concentration: Dextromethorphan Hydrobromide 0.2mg / ml, Quinidine Sulfate 0.1mg / ml)

[0058] Test solution 1: Take 1 capsule of this product, place it in a 100ml measuring bottle, add an appropriate amount of mobile phase A, soak for 30 minutes, ultrasonicate for 5 minutes to dissolve, let cool to room temperature, dilute to the mark with mobile phase A, shake well, filter.

[0059] Test solution 2: Take 5 capsules of this product, place them in a 100ml measuring bottle, add an appropriate amount of mobile phase A, soak for 30 minutes, ultrasonicate for 5 minutes t...

Embodiment 2

[0096] Example 2: System Suitability

[0097] The system applicability is checked by repeating the 5-point reference solution, and the RSD of the peak area of ​​the 5-point reference solution is required to be ≤ 2.0%, and the RSD of 6 needles (or more than 6 needles) is ≤ 3.0%; the recovery rate of the reference solution should be 98.0% ~102.0%; the number of theoretical plates of dextromethorphan hydrobromide peak and quinidine sulfate peak is not less than 2000. After the system is stabilized, inject 1 injection of blank solution and 5 injections of reference substance solution.

[0098]

[0099]

Embodiment 3

[0100] Example 3: Specificity

[0101] Specificity requires that the blank solution and blank excipients (including capsule shell) have no interference to the detection, and the blank solution and blank excipients (including capsule shell) have no interference on the detection. Dextromethorphan hydrobromide and quinidine sulfate in the test solution The retention time of the test solution is consistent with that of the reference substance solution. If there is an unknown peak in the test solution, the separation degree of the main peak and the adjacent peak is not less than 1.5, and the number of theoretical plates of the dextromethorphan hydrobromide peak and the quinidine sulfate peak is not less than 2000. The purity matching value of dextromethorphan hydrobromide peak and quinidine sulfate peak in the test solution and reference solution is not less than 980. After the system is stabilized, blank solution, blank excipient (including capsule shell) solution, reference soluti...

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, particularly relates to a method for detecting the content of dextromethorphan hydrobromide and quinidine sulfate capsules, and provides a convenient, efficient and accurate detection method for solving the detection problem of a method for detecting the content of dextromethorphan hydrobromide and quinidine sulfate capsules. The method can be used for detecting the content of the dextromethorphan hydrobromide and quinidine sulfate capsules, so that the medication safety is effectively guaranteed, the quality control of the dextromethorphan hydrobromide and quinidine sulfate capsules is facilitated, the method is convenient, efficient and accurate, the system applicability, repeatability, specificity and accuracy completely accord with the guidance principle verified by a Chinese pharmacopoeia method, and the method can be used for quality control of the dextromethorphan hydrobromide quinidine sulfate capsules.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for detecting the content of dextromethorphan hydrobromide and quinidine sulfate capsules. Background technique [0002] In 2010, the FDA approved the marketing of dextromethorphan hydrobromide quinidine sulfate capsules (trade name: NUEDEXTA). The dextromethorphan hydrobromide in the compound capsule preparation is a sigma-1 receptor agonist and a non-competitive NMDA A receptor antagonist, quinidine reduces the biotransformation of dextromethorphan by competitively inhibiting cytochrome P450 2D6, thereby increasing plasma levels of dextromethorphan. The compound drug NUEDEXTA composed of the two is used to treat pseudobulbar affect (Pseudobulbaraffect, PBA), PBA is also known as emotional incontinence, mainly secondary to brain damage or diseases such as multiple sclerosis, amyotrophic lateral sclerosis and stroke. Nervous disease, characterized by sudden uncons...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 谢岳庭董欣圆谢斌兰柳琴
Owner 珠海润都制药股份有限公司
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