Method for determining related substances of pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate

A technology of dextromethorphan hydrobromide and doxylamine succinate, applied in the field of medicine, can solve problems such as no simultaneous measurement, and achieve the effects of effective separation, saving detection time and detection cost

Active Publication Date: 2020-09-29
安士制药(中山)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, there is no method capable of simultaneously determining related substance...

Method used

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  • Method for determining related substances of pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate
  • Method for determining related substances of pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate
  • Method for determining related substances of pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0053] 1. Solution preparation

[0054] The diluent in the embodiment is a 0.01mol / L hydrochloric acid solution containing 20% ​​by volume of methanol. The inventor has verified through experiments that the diluent has a good dissolving effect on acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and related substances in the soft capsule.

[0055] (1) Preparation of test solution

[0056] Take the pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate, put it in a container, add diluent and heat, shake, dissolve and dilute to the mark, shake well, filter to obtain The test solution.

[0057] (2) Preparation of sensitivity solution

[0058] Take dextromethorphan impurity Ⅰ, dextromethorphan impurity Ⅱ, dextromethorphan impurity Ⅲ, dextromethorphan impurity Ⅳ, acetaminophen, doxylamine succinate and dextromethorphan hydrobromide, put them in a container, add dilute solution, ultrasonically dissolved, dilut...

experiment example 1

[0087] Establishment of detection method:

[0088] A method for detecting related substances in soft capsules containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate, which is carried out by high performance liquid chromatography. Include the following steps:

[0089] Preparation contains the soft capsule sample solution of paracetamol, dextromethorphan hydrobromide and doxylamine succinate, and described soft capsule sample solution comprises need testing solution, reference substance solution, system suitability solution and sensitivity solution.

[0090] Preparation of the test solution: Take the soft capsules containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate, put them in a container, add diluent and heat, shake, dissolve and dilute to the mark , shake well, and filter to obtain the test solution. In the test solution, the concentration of acetaminophen was 9.1 mg / mL, the concentration of doxylamine succinate was 175 μ...

experiment example 2

[0100] This experimental example has verified the feasibility of the chromatographic conditions used in the present invention. Specifically, adopt the chromatographic condition of above-mentioned experimental method to measure respectively reference substance solution, system adaptability solution and test solution, from Figure 1~3 It can be seen from Tables 2 to 3 that there is a good separation between the three main component peaks and their related substance peaks in the system adaptability solution collected by using the HPLC conditions of the present invention. There are no other interference peaks near the three main component peaks in the test solution collected by adopting the HPLC conditions of the present invention, and the separation degree is good.

[0101] Table 2 System adaptability test results

[0102]

[0103] Table 3 test result of test solution

[0104]

[0105]

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Abstract

The invention discloses a method for determining related substances of a pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate. The determinationmethod disclosed by the invention is carried out by adopting a high performance liquid chromatography; proper HPLC chromatographic conditions are selected, four related substances including a dextromethorphan impurity I, a dextromethorphan impurity II, a dextromethorphan impurity III and a dextromethorphan impurity IV in a pharmaceutical preparation of acetaminophen, dextromethorphan hydrobromideand doxylamine succinate can be simultaneously determined under the same condition; effective separation of various impurities can be realized, and the detection time and the detection cost are greatly saved. The method can be used for quality research and quality control of pharmaceutical preparation products containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for determining related substances of a pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate. Background technique [0002] As a common respiratory disease, colds are mainly manifested in the following symptoms: headache, fever, cough, nasal congestion, runny nose, allergies, etc. Medications commonly used to treat these symptoms include: antipyretic pain relievers (acetaminophen), cough suppressants (dextromethorphan hydrobromide), and antihistamines (doxylamine succinate). [0003] The soft capsule containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate is a compound oral solid preparation made of gelatin, and its preparation method is as described in Chinese patent 201310359375.2. Research still needs to be improved. In the prior art, there is no method capable of simultaneously determi...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/8679
Inventor 邱科先刘晓芬谭惠敏吴肖燕李婷
Owner 安士制药(中山)有限公司
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