Method for analyzing night cold flu cough allergy capsule by utilizing HPLC (High Performance Liquid Chromatography)

A high-performance liquid chromatography, soft capsule technology, applied in the field of drug analysis, to achieve the effects of improving peak shape, increasing response, and increasing retention

Active Publication Date: 2014-10-29
HUMANWELL PURACAP PHARM WUHAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, in the prior art, there is no public report on the simultaneous determination of acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide in Aminemeline II soft capsules.

Method used

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  • Method for analyzing night cold flu cough allergy capsule by utilizing HPLC (High Performance Liquid Chromatography)
  • Method for analyzing night cold flu cough allergy capsule by utilizing HPLC (High Performance Liquid Chromatography)
  • Method for analyzing night cold flu cough allergy capsule by utilizing HPLC (High Performance Liquid Chromatography)

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Chromatographic conditions:

[0075] High performance liquid chromatography: Waters e2996, PDA detector; Chromatographic column: Agilent SB-C18, 4.6×150mm, 5μm; Sodium octane sulfonate concentration is 3 mmol / L sodium octane sulfonate-phosphate buffer solution (weigh 0.65g sodium octane sulfonate, 3.12g sodium dihydrogen phosphate into 1L water, adjust pH to 2.5 with phosphoric acid, degas, filter) as mobile phase A, using acetonitrile as mobile phase B, carry out gradient elution, Gradient elution conditions are shown in Table 1; flow rate: 1.2 ml / min; detection wavelength: 275 nm; column temperature: 35°C; injection volume: 20 μL.

[0076] Table 1

[0077] time (min)

Mobile phase A (V%)

Mobile phase B (V%)

0

90

10

1

90

10

16

50

50

17

90

10

21

90

10

[0078] Experimental steps:

[0079](1) Preparation of contrast solution: Accurately weigh 65 mg of paracetamol referenc...

Embodiment 2

[0083] Chromatographic conditions:

[0084] High-performance liquid chromatography: Waters e2996, PDA detector; chromatographic column: Agilent SB-C18, 4.6 × 150mm, 5 μm; sodium octane sulfonate-phosphate buffer with a concentration of sodium octane sulfonate of 3 mmol / L Solution (weigh 0.65g sodium octane sulfonate, 3.12g sodium dihydrogen phosphate into 1L water, adjust pH to 3.0 with phosphoric acid, degas, filter) as mobile phase A, use acetonitrile as mobile phase B, carry out gradient elution , gradient elution conditions are shown in Table 1; flow rate: 1.2 ml / min; detection wavelength: 278nm; column temperature: 35°C; injection volume: 20 μL.

[0085] Experimental procedure: with embodiment 1.

[0086] Its HPLC spectrum is as Figure 4~6 .

Embodiment 3

[0088] Chromatographic conditions:

[0089] High-performance liquid chromatography: Waters e2996, PDA detector; chromatographic column: Agilent SB-C18, 4.6×150mm, 5μm; sodium octanesulfonate-phosphate buffer with a concentration of sodium octanesulfonate of 2 mmol / L Solution (weigh 0.43g sodium octane sulfonate, 3.12g sodium dihydrogen phosphate into 1L water, adjust pH to 2.5 with phosphoric acid, degas, filter) as mobile phase A, use acetonitrile as mobile phase B, carry out gradient elution , gradient elution conditions are shown in Table 1; flow rate: 1.2 ml / min; detection wavelength: 275nm; column temperature: 35°C; injection volume: 20 μL;

[0090] Experimental procedure: with embodiment 1.

[0091] Its HPLC spectrum is as Figure 7-9 .

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Abstract

The invention discloses a method for analyzing a night cold flu cough allergy capsule by utilizing HPLC (High Performance Liquid Chromatography). The night cold flu cough allergy capsule contains acetaminophen, phenylephrine hydrochloride, succinic acid doxylamine and dextromethorphan hydrobromide. In the HPLC analysis, an octadecyl silane bonded silica gel column is adopted as a chromatographic column; a sodium 1-octanesulfonate-phosphate buffer solution with the pH of 2.0-3.0 acts as a mobile phase A; acetonitrile and a mixed solution of acetonitrile and methyl alcohol act as a mobile phase B. The method can be simultaneously and effectively used for detecting four effective ingredients in the night cold flu cough allergy capsule, is simple to operate, analyzes rapidly, is good in repeatability, has favorable specificity, and can effectively and comprehensively control the product quality of the night cold flu cough allergy capsule.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular, the invention relates to a method for analyzing aminomethamine II soft capsules by using high performance liquid chromatography. Background technique [0002] Cold is one of the most common respiratory diseases. There are many kinds of medicines for treating colds. Western medicines are very popular because of their relatively transparent safety and quick results. Most cold medicines are compound preparations. For Western medicine, the composition of cold medicine mainly includes the following types of drugs: antipyretic and analgesic drugs, adrenergic receptor agonists, antihistamines, antitussive and expectorant drugs, antiviral drugs Wait. Amamimin Ⅱ soft capsule (English name: Night cold flu cough allergy (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride) capsule) is a cold medicine, each capsule contains acetaminophen 325m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 秦巨波郭云梅蔡波涛文学智沈福星丁超
Owner HUMANWELL PURACAP PHARM WUHAN CO LTD
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