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

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

Inactive Publication Date: 2008-05-14
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
  • Content detecting method for Ibuprofen, chlorphenamine maleate and Pseudoephedrine Hydrochloride compound preparation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

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

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

[0020] 2. Selection of detection wavelength:

[0021] Accurately weigh 20 mg of chlorpheniramine maleate reference substance, put it in a ...

Embodiment 2

[0026] Embodiment two: the mensuration of the content of ibuprofen and pseudoephedrine tablets

[0027] Take 20 tablets of ibuprofen and pseudoephedrine, accurately weigh, grind finely, accurately weigh an appropriate amount (approximately equivalent to ibuprofen 40mg) and put it in a 100ml measuring bottle, add phosphate buffer to the mark, ultrasonically dissolve for 30 minutes, filter After that, get the continued filtrate as the test solution; get another reference substance ibuprofen 40mg, pseudoephedrine hydrochloride 6mg and chlorpheniramine maleate 0.4mg to put in the same 100ml measuring bottle, add phosphate buffer saline ultrasonic dissolution for 30 minutes, And dilute to scale, shake up, as reference substance 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 of sodium lauryl sulfate in a 1000ml measu...

Embodiment 3

[0030] Embodiment three: the mensuration of the content of Buluo pseudoannamin capsule

[0031]Take 20 capsules of Buluo pseudoanamin, after accurately weighing, pour out the contents (capsule shell should not be lost), wipe the capsule shell with a small brush, and then accurately weigh; take the capsule contents and mix them evenly, grind them finely, and accurately weigh them. Get an appropriate amount (approximately equivalent to ibuprofen 40mg) in a 100ml measuring bottle, add phosphate buffered saline to the mark, ultrasonically dissolve for 30 minutes, filter, and get the subsequent filtrate as the test solution; another reference substance ibuprofen 40mg , Pseudoephedrine hydrochloride 6mg and chlorpheniramine maleate 0.4mg are put in the same 100ml measuring bottle, add phosphate buffer saline solution and ultrasonically dissolve for 30 minutes, and dilute to the mark, shake well, as the reference substance solution; Conditions: VP-ODS chromatographic column (250mm×4....

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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 content detection method of a compound preparation of ibuprofen and pseudoanaminamine, which belongs to the field of analysis and detection of compound pharmaceutical preparations. Background technique [0002] The compound preparation of ibuprofen and pseudoephedrine 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 and sneezing. symptom. The method of using high performance liquid chromatography (HPLC) to measure the content of each component in the compound drug 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 contents of the three components in the compound preparation of ibuprofen-ps...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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