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Method for measuring buprofen/famotidine compound preparation content

A compound preparation and a technology for the preparation are applied in the fields of determining the content of the ibuprofen/famotidine compound preparation by using high performance liquid chromatography, and measuring the content of the ibuprofen/famotidine compound preparation, achieving high precision and repeatability. The effect of good performance and accurate content determination results

Active Publication Date: 2013-08-21
NANJING CORE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the prior art has disclosed the detection method of the preparation with ibuprofen or famotidine as the only active ingredient, but there is no detection method for the content of the ibuprofen / famotidine compound preparation

Method used

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  • Method for measuring buprofen/famotidine compound preparation content
  • Method for measuring buprofen/famotidine compound preparation content
  • Method for measuring buprofen/famotidine compound preparation content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1 High performance liquid chromatography is measured ibuprofen / famotidine compound preparation content

[0019] Take an appropriate amount of ibuprofen / famotidine compound preparation sample, dissolve it with methanol as solvent, adopt high performance liquid chromatography, use octadecylsilane bonded silica gel filler as stationary phase, according to the following mobile phase conditions, use ultraviolet The detector detects, and calculates the content of ibuprofen and famotidine according to the external standard method.

[0020] Mobile phase A: Dissolve 3.28g of anhydrous sodium acetate solution in 1500mL of water, adjust the pH to 4.0 with phosphoric acid, and then dilute to 2000mL with water.

[0021] Mobile Phase B: Acetonitrile.

[0022] Total flow rate: 1.0mL / min

[0023] Wavelength: 265nm

[0024] Elution gradient

[0025] time (min)

mobile phase A

mobile phase B

0

90

10

7

90

10

10

40

...

Embodiment 2

[0040] The precision research test of embodiment 2 assay method of the present invention

[0041] (1) Linear

[0042] Take an appropriate amount of ibuprofen and famotidine reference substances, dissolve them in proportion with methanol as a solvent, and dilute according to the gradient concentration, adopt high performance liquid chromatography, use octadecylsilane bonded silica gel filler as the stationary phase, and press Samples were injected under the aforementioned mobile phase conditions, and detected at a wavelength of 265 nm by an ultraviolet detector. With the concentration (mg / mL) as the abscissa and the peak area as the ordinate, draw a regression curve and calculate the regression coefficient. The results are shown in Table 1, image 3 , Figure 4 .

[0043] Table 1 standard curve

[0044]

[0045] It can be seen from the results that ibuprofen showed good linearity in the concentration range of 0.589-5.888 mg; famotidine showed good linearity in the range...

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Abstract

The invention discloses a method for measuring a buprofen / famotidine compound preparation content. The method comprises the following steps of: dissolving a compound preparation sample by methanol as a solvent; measuring by using a high performance liquid chromatography, wherein the measurement wavelength is 265nm; and with an octadecyl silane bonded silica gel filler as a stationary phase, performing gradient elution according to the following mobile phase conditions: the mobile phase A is a 0.02mol / L sodium acetate solution, pH is regulated to be 4.0 by using phosphoric acid, and the mobile phase B is acetonitrile. The method provided by the invention is time-saving and labor-saving, high in precision, accurate in content determination result and excellent in repeatability, and can be used for conventional analysis and quality control on the buprofen / famotidine compound preparation sample.

Description

technical field [0001] The invention relates to a method for determining the content of an ibuprofen / famotidine compound preparation, in particular to a method for determining the content of an ibuprofen / famotidine compound preparation by high performance liquid chromatography, belonging to the technical field of drug analysis . Background technique [0002] The chemical name of ibuprofen is 2-(-4-isobutylphenyl)propionic acid, and the molecular formula is C 13 h 18 o 2 , the molecular weight is 206.3. The drug has anti-inflammatory, analgesic and antipyretic effects, and is suitable for the treatment of rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and neuritis, etc. [0003] The chemical name of famotidine is 3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-N-sulfamoylpropionamidine, and its molecular formula is C 8 h 15 N 7 o 2 S 3 , the molecular weight is 337.5. Histamine H 2 receptor antagonists. It has obvious ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 王雪根何凌云周磊
Owner NANJING CORE TECH CO LTD
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