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Method for determining contents of chlorpheniramine maleate and acetaminophen in Ankahuangmin tablet

A technology for acetaminophen and chlorpheniramine acid, which is applied in the field of drug testing, can solve problems such as the lack of control of the content of chlorpheniramine maleate, and achieve improved quality controllability, good separation, and repeatability Good results

Inactive Publication Date: 2018-12-07
贵州省科晖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The current national standard only establishes the visible / ultraviolet spectrophotometric method for determining the content of acetaminophen, but does not control the content of chlorpheniramine maleate

Method used

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  • Method for determining contents of chlorpheniramine maleate and acetaminophen in Ankahuangmin tablet
  • Method for determining contents of chlorpheniramine maleate and acetaminophen in Ankahuangmin tablet
  • Method for determining contents of chlorpheniramine maleate and acetaminophen in Ankahuangmin tablet

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Experimental program
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Effect test

Embodiment 1

[0055] Embodiment 1: the content determination of chlorpheniramine maleate in Ankahuangmin tablets

[0056] In the present embodiment, the reference substance solutions are all chlorpheniramine maleate reference substance solutions; both chlorpheniramine maleate and acetaminophen double negative control solutions are chlorpheniramine maleate and acetaminophen double negative control solutions. Negative control solution ①; need testing solution is need testing solution ①.

[0057] System suitability test:

[0058] Inject the chlorpheniramine maleate reference substance solution, the chlorpheniramine maleate and acetaminophen double negative control solution and the test solution into the liquid chromatograph, record the chromatogram, and the blank control solution is at the position of the reference substance Without interfering peaks, the number of theoretical plates of the chlorpheniramine maleate sample solution under the above conditions is 13915, the degree of separation ...

Embodiment 2

[0083] Embodiment 2: Determination of the content of acetaminophen in Ankahuangmin Tablets

[0084] In this embodiment, the reference substance solution is all paracetamol reference substance solution; both chlorpheniramine maleate and paracetamol double negative control solution are both chlorpheniramine maleate and paracetamol double negative control solution ②; the test solution is the test solution ②.

[0085] System suitability test:

[0086] Inject paracetamol reference substance solution, double negative control solution and need testing solution into liquid chromatograph, record the chromatogram, blank control solution has no interference peak at the position of reference substance, under the above conditions paracetamol sample solution The number of theoretical plates is 14547, the resolution is 37.6, and the tailing factor is 1.16. The reference values ​​are in line with the 2010 Pharmacopoeia regulations. Specific as Figure 5 , Figure 6 , Figure 7 .

[008...

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Abstract

The invention relates to the technical field of drug detection, in particular to a method for determining contents of chlorpheniramine maleate and acetaminophen in Ankahuangmin tablet. The method adopts a HPLC method for detecting the chlorpheniramine maleate and the acetaminophen in the Ankahuangmin tablet, octadecylsilane bonded silica is used as a filler, 0.01 mol / L potassium dihydrogen phosphate solution-methanol-triethylamine-phosphoric acid (with a ratio of 95:5:0.4:0.2) is used as a mobile phase; detection wavelength is 215 nm, flow rate is 1 mL / min, and column temperature is 30 DEG C.The method is simple, accurate and well-reproducible, has a good separation degree for the chlorpheniramine maleate and the acetaminophen, can improve the quality controllability of the Ankahuangmin tablet, thereby improving drug safety, and provides a reference for quality control of the Ankahuangmin tablet.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a method for determining the contents of chlorpheniramine maleate and acetaminophen in Ankahuangmin tablets. Background technique [0002] Anka Huangmin Tablets is a compound preparation composed of chlorpheniramine maleate and acetaminophen, which is a commonly used anti-cold medicine in clinical practice. The current national standard only establishes the visible / ultraviolet spectrophotometric method for determining the content of acetaminophen, but does not control the content of chlorpheniramine maleate. In order to improve the quality controllability of Anka Huangmin tablets, thereby improving the safety of the drug. It is necessary to improve the quality standard of Ankahuangmin Tablets, draw up internal quality standards, and establish a method for the determination of chlorpheniramine maleate and acetaminophen in Ankahuangmin Tablets. [0003] Therefore, it is ur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02B01D15/10
CPCG01N30/02B01D15/10
Inventor 陆宽冯发进霍昕李计龙高玉琼
Owner 贵州省科晖制药有限公司
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