Method for determining content of three components comprising phenylephrine hydrochloride, chlorphenamine maleate and ibuprofen in compound cold treatment tablet

A technology of phenylephrine hydrochloride and chlorpheniramine acid, applied in the field of medical testing, achieves the effects of good repeatability, comprehensive quality testing indicators, and product quality control

Active Publication Date: 2014-12-31
SHENZHEN NEPTUNUS PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, there is no disclosure about the simultaneous determination of the content of the three pharmaceutical components of phenylephrine hydrochlori

Method used

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  • Method for determining content of three components comprising phenylephrine hydrochloride, chlorphenamine maleate and ibuprofen in compound cold treatment tablet
  • Method for determining content of three components comprising phenylephrine hydrochloride, chlorphenamine maleate and ibuprofen in compound cold treatment tablet
  • Method for determining content of three components comprising phenylephrine hydrochloride, chlorphenamine maleate and ibuprofen in compound cold treatment tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] [Example 1] Preparation of Reference Substance Solution

[0032] Get respectively phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen reference substance, accurately weighed, and add solvent to make each 1ml solution containing phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen respectively. The mixed solution of ibuprofen is 6.64, 0.332, 0.132mg respectively, namely.

Embodiment 2

[0033] [Example 2] Screening of chromatographic conditions and system suitability

[0034] 2.1 Selection of mobile phase

[0035] Referring to the relevant literature and combined with the specific conditions of the test, acetonitrile-phosphate buffer (0.04mol / L disodium hydrogen phosphate, adjusted to pH 6.0 with phosphoric acid), acetonitrile-phosphate buffer (0.04mol / L dihydrogen phosphate Sodium, use phosphoric acid to adjust the pH to 2.6), acetonitrile-sodium octane sulfonate solution (3.25g / L sodium octane sulfonate solution, adjust the pH value to 6.0 with phosphoric acid), acetonitrile-sodium octane sulfonate solution (3.25 g / L sodium octane sulfonate solution, adjust the pH value to 2.6 with phosphoric acid), and the separation effects under the conditions of each mobile phase are as follows (see Table 1)

[0036] Table 1. Mobile phase selection results

[0037]

[0038] 2.2 Selection of chromatographic column

[0039] After trying different brands and models o...

Embodiment 3

[0057] [embodiment 3] the preparation of need testing solution

[0058] Take the compound cold medicine tablet (batch number 20130416) of the test product and accurately weigh it to make a solution with a concentration of 4 mg / ml. The specific steps are to take the compound cold medicine tablet, grind it finely, take about 20mg of the powder, weigh it accurately, put it in a 5ml volumetric flask, ultrasonically treat it for 10 minutes, let it cool, add solvent to dilute to the scale, shake well, filter, and take the subsequent filtrate, Instantly.

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Abstract

he invention discloses a method for simultaneously determining phenylephrine hydrochloride, chlorphenamine maleate and ibuprofen in a compound cold treatment medicine. The method comprises the following steps: respectively preparing a phenylephrine hydrochloride reference substance solution, a chlorphenamine maleate reference substance solution and an ibuprofen reference substance solution; preparing a compound cold treatment medicine sample solution; and determining through high performance liquid chromatography, wherein octadecyl silane-bonded silica gel (2504.0mm, 5mum) is used as a filler, a sodium octane sulfonate solution is used as a mobile phase A, acetonitrile is used as a mobile phase B, gradient elution is carried out, the column temperature is 35DEG C, the flow velocity is 1ml/min, and the detection wavelength is 264nm.

Description

technical field [0001] The invention relates to the field of medical detection, in particular to a method for determining compound cold medicine. Background technique [0002] The main ingredients of compound cold medicine are phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen, which are used to relieve fever, headache, nasal congestion, sneezing and other symptoms caused by colds. The trade name is Advil, and the compound preparation was launched in the United States in 2012, but it is not currently on the market in China. In the prior art, there is no disclosure about the simultaneous determination of the contents of the three pharmaceutical ingredients phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen in the solution, and there are only some methods for the content determination of single or two components. The current standard uses iodine titration, potentiometric titration and acid-base titration to determine the contents of phenyleph...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34G01N30/06
Inventor 胥娜朱丹刘小柔高媛王菲冯汉林于琳
Owner SHENZHEN NEPTUNUS PHARMA RES INST CO LTD
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