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Determination method of phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen in compound cold medicine tablets

A technology of phenylephrine hydrochloride and chlorpheniramine acid is applied in the field of medical testing to achieve the effects of controlling product quality, comprehensive quality testing indicators and good repeatability

Active Publication Date: 2016-06-01
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 hydrochloride, chlorpheniramine maleate and ibuprofen in the solution, and there are only some methods for the content determination of single components or two components

Method used

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  • Determination method of phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen in compound cold medicine tablets
  • Determination method of phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen in compound cold medicine tablets
  • Determination method of phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen in compound cold medicine tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] [Example 1] Preparation of reference solution

[0032] Take phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen reference substances respectively, accurately weigh them, and add a solvent to make each 1ml solution containing phenylephrine hydrochloride, chlorpheniramine maleate and Ibuprofen is a mixed solution of 6.64, 0.332, and 0.132 mg, respectively, to obtain.

Embodiment 2

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

[0034] 2.1 Selection of mobile phase

[0035] According to the relevant literature and the specific conditions of the experiment, acetonitrile-phosphate buffer (0.04mol / L disodium hydrogen phosphate, adjusted to pH 6.0 with phosphoric acid), acetonitrile-phosphate buffer (0.04mol / L hydrogen phosphate dibasic Sodium, adjust the pH to 2.6 with phosphoric acid, acetonitrile-sodium octane sulfonate solution (3.25g / L sodium octane sulfonate solution, adjust the pH to 6.0 with phosphoric acid), acetonitrile-octane sulfonate sodium solution (3.25 g / L sodium octane sulfonate solution, adjust the pH to 2.6 with phosphoric acid), the separation effect under each mobile phase condition is as follows (see Table 1)

[0036] Table 1. Mobile phase selection results

[0037]

[0038] 2.2 Selection of Column

[0039] Try different brands and models of chromatographic columns, and finally decide to use Kromasil (C1825...

Embodiment 3

[0057] [Example 3] Preparation of test solution

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

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PUM

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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 testing, in particular to a method for determining a compound cold medicine. Background technique [0002] The main components of the 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. The compound preparation was launched in the United States in 2012 and is not currently on the domestic market. The prior art does not disclose a method for simultaneously determining the content of three pharmaceutical components of phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen in a solution, and only a part of the method for determining the content of a single component or two components. The current standard uses iodine titration, potentiometric titration and acid-base titration to determine the content of phenylephrine hydrochlorid...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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