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Content detecting method for Ibuprofen, chlorphenamine maleate and Pseudoephedrine Hydrochloride compound preparation

A detection method and a technology for compound preparations are applied in the field of content detection of ibuprofen-pseudoanamin compound preparations, which can solve the problems of high detection cost, long test time and the like, and achieve the effects of high sensitivity, good reproducibility and simple operation.

Inactive Publication Date: 2007-01-03
SHANDONG INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method of measuring the content of each component in the compound drug by high performance liquid chromatography (HPLC) has been reported, but basically only one component can be detected under one mobile phase condition, the test time is long, and the detection cost is high
At present, there is no report on the simultaneous determination of the three components in the compound preparation of ibuprofen-pseudopheniramine with one mobile phase condition

Method used

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  • Content detecting method for Ibuprofen, chlorphenamine maleate and Pseudoephedrine Hydrochloride compound preparation
  • Content detecting method for Ibuprofen, chlorphenamine maleate and Pseudoephedrine Hydrochloride compound preparation

Examples

Experimental program
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Embodiment 1

[0018] 1. Chromatographic conditions and system suitability test:

[0019] Waters 600 Pump type high performance liquid chromatograph (Waters, USA); Waters 996Photodiode Array detector (Waters, USA); Column: VP-ODS column (250mm×4.6mm; 100A); Mobile phase: potassium dihydrogen phosphate solution (8.16g potassium dihydrogen phosphate and 2.8g sodium lauryl sulfate in a 1000ml measuring flask, add water to dissolve, and dilute to the mark, shake well)-methanol-acetonitrile-triethylamine (40:20:40:0.1) It is the mobile phase (adjust the pH to 4.0-5.0 with phosphoric acid); the detection wavelength is 215nm-225nm; the number of theoretical plates should not be less than 3000 based on the ibuprofen peak. The resolution of each peak of ibuprofen, pseudoephedrine hydrochloride, and chlorpheniramine maleate should meet the requirements.

[0020] 2. Selection of detection wavelength:

[0021] Precisely weigh 20mg of chlorpheniramine maleate reference substance into a 50ml measuring bottle,...

Embodiment 2

[0026] Example 2: Determination of the content of ibuprofen and pseudoephedrine tablets

[0027] Take 20 ibuprofen and pseudoephedrine tablets, accurately weigh, grind, and accurately weigh an appropriate amount (about 40mg of ibuprofen) into a 100ml measuring flask, add phosphate buffer to the mark, dissolve it by ultrasound for 30 minutes, and filter After that, take the continued filtrate as the test solution; also take the reference substance ibuprofen 40mg, pseudoephedrine hydrochloride 6mg and chlorpheniramine maleate 0.4mg in the same 100ml measuring flask, add phosphate buffer solution to ultrasonic dissolve for 30 minutes, And dilute to the mark, shake up, as the reference solution; under the following selected chromatographic conditions: VP-ODS chromatographic column (250mm × 4.6mm; 100A); with potassium dihydrogen phosphate solution (8.16g potassium dihydrogen phosphate and Put 2.8g sodium lauryl sulfate in a 1000ml measuring flask, add water to dissolve, dilute to the ...

Embodiment 3

[0029] Example 3: Determination of the content of ibuprofen and pseudoephedrine capsules

[0030]Take 20 capsules of Buluo and Pseudoephedrine capsules. After precise weighing, pour out the contents (without losing the capsule shell), wipe the capsule shell with a small brush and weigh it accurately; mix the contents of the capsules evenly, grind finely, and weigh accurately Take an appropriate amount (approximately equivalent to 40mg of ibuprofen) and place it in a 100ml measuring flask, add phosphate buffer to the mark, dissolve it with ultrasound for 30 minutes, filter, and take the subsequent filtrate as the test solution; take the reference ibuprofen 40mg , Pseudoephedrine hydrochloride 6mg and chlorpheniramine maleate 0.4mg in the same 100ml measuring flask, add phosphate buffer solution to ultrasonic dissolve for 30 minutes, and dilute to the mark, shake well, as the reference solution; select the chromatogram below Condition: VP-ODS chromatographic column (250mm×4.6mm; 100...

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Abstract

A content detecting method for pro-pseudo-chlorpheniramine compound preparation uses octadecyl silance bonding colloidal silica as packing agent. The mobile phase is monopotassium phosphate, methanol and triethyl-amine and the detecting wavelength is 215-225nm. Dissolve suitable pro-pseudo-chlorpheniramine preparation in the need testing solution with phosphate buffer solution under ultrasonic sound condition. Dissolve suitable ibuprofen, hydrochloric acid pseudoephedrine and chlorphenamine Maleate in the comparison solution with phosphate buffer solution under ultrasonic sound condition. Take each 10-20 mul of the need testing solution and the comparison solution accurately and inject into liquid chromatograph spectrometer and record chromatogram graph. Use peak acreage to calculate the content to ibuprofen, hydrochloric acid pseudoephedrine and chlorphenamine Maleate with the external standard method. It can confirm the content to three kind of component in compound preparation by using one mobile phase with the sententious and fast virtues to inspect the stability to the production and control the procreative quality of industrialization.

Description

Technical field [0001] The invention relates to a method for detecting the content of a compound preparation of ibuprofen and pseudoephedrine, which belongs to the field of analysis and detection of compound pharmaceutical preparations. Background technique [0002] Ibuprofen and pseudoephedrine compound preparation is a compound anti-cold medicine made of three ingredients: ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate. It is used to relieve colds such as headache, fever, nasal congestion, runny nose, sneezing, etc. symptom. The method of using high-performance liquid chromatography (HPLC) to determine the content of each component in a compound drug has been reported, but basically only one component can be detected under a mobile phase condition, the test time is long, and the detection cost is high. At present, there is no report of using one mobile phase condition to simultaneously determine the content of the three components in ibuprofen and pseudoe...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N33/15G06F19/00
Inventor 王原孙小雨王金虎白万军
Owner SHANDONG INST OF PHARMA IND
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