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Method for determining related substances of pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride

A technology of phenylephrine hydrochloride and dextromethorphan hydrobromide, applied in the field of medicine, can solve the problem of no simultaneous measurement and the like, and achieve the effects of saving detection cost, saving detection time and effective separation

Active Publication Date: 2020-07-17
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 substances in soft capsules containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride

Method used

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  • Method for determining related substances of pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride
  • Method for determining related substances of pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride
  • Method for determining related substances of pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0054] 1. Solution preparation

[0055] (1) Preparation of test solution

[0056] The soft capsules containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride to be tested were treated with diluent to obtain the test liquid. In the embodiment of the present invention, the diluent is 0.01 mol / L hydrochloric acid solution containing 20 volume % methanol. The inventor has verified through experiments that the 0.01N hydrochloric acid solution containing 20% ​​by volume of methanol can effectively dissolve acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride and related substances in the soft capsule.

[0057] (2) Preparation of sensitivity solution

[0058] Take dextromethorphan impurity Ⅰ, dextromethorphan impurity Ⅱ, dextromethorphan impurity Ⅲ, dextromethorphan impurity Ⅳ, norepinephrine, phenylephrine related substance F, 4,6 diol isoquinoline analogues, nor An appropriate amount of oxyepinephrine-related substance C, 3-hydr...

experiment example 1

[0087] Establishment of detection method:

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

[0089] Prepare the soft capsule sample solution containing paracetamol, dextromethorphan hydrobromide and phenylephrine hydrochloride, the soft capsule sample solution containing paracetamol, dextromethorphan hydrobromide and phenylephrine hydrochloride Including the test solution, reference solution, system suitability solution and sensitivity solution.

[0090] The test solution: take an appropriate amount of capsules, put them in a container of a certain volume, add diluent, heat to disintegrate the capsule shell, shake, dissolve and dilute to the scale, shake well, filter, and obtain the test solution. The concentration of paracetamol in the solution is 13 mg / mL, the concentration o...

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 Table 2-3 that the three main component peaks and their related substance peaks in the system suitability solution obtained by using the HPLC conditions of the present invention have good separation. 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] peak name keep time Peak area Separation Phenphrine Related Compound G 4.714 374807 / unsp...

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Abstract

The invention discloses a method for determining related substances of a pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride. The determination method disclosed by the invention is performed by adopting a high performance liquid chromatography; proper HPLC chromatographic conditions are screened out; and 10 related substances of dextromethorphan impurities I, dextromethorphan impurities II, dextromethorphan impurities III, dextromethorphan impurities IV, norepinephrine, a phenylephrine related substance F, a 4,6 diol isoquinoline analogue, a phenylephrine related substance C, 3-hydroxybenzaldehyde and a phenylephrine related substance G in the pharmaceutical preparation of acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride can be simultaneously determined under the same condition. Effective separation of a variety of impurities can be achieved, and detection time and detection cost are greatly saved. The method can be used for quality research and quality control of pharmaceutical preparation products containing the acetaminophen, the dextromethorphan hydrobromide and the phenylephrine hydrochloride.

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 phenylephrine hydrochloride. 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 decongestants (phenylephrine hydrochloride). [0003] The soft capsule containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride is a compound oral solid preparation made of gelatin. Its preparation method is as described in Chinese patent 201310360549.7. The current research on this product There is still room for improvement. In the prior art,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 刘晓芬吴肖燕董杰英李婷叶爱群梁倩婷谭惠敏涂芳林淑平
Owner 安士制药(中山)有限公司
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