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Method for simultaneous determination of content of ibuprofen and arginine in ibuprofen injection

A method for measuring arginine, which is applied in the field of simultaneous determination of ibuprofen and arginine content in ibuprofen injection, and the determination of substance content, can solve the problem of method precision, accuracy, reproducibility, Complicated operation, damage to the chromatographic column, etc.

Active Publication Date: 2013-01-02
JILIN SIHUAN PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] It is recorded in the Chinese Pharmacopoeia that the determination method of arginine content in arginine tablets is a derivatization method, using 2,4-dinitrofluorophenylacetonitrile as a derivatization reagent, after a derivatization reaction in the dark, diluted, and injected into a chromatograph for detection Although the derivatization reaction also improves the specificity, the derivatization reaction is easy to damage the chromatographic column and shorten the service life of the chromatographic column. Accuracy, accuracy, reproducibility, etc. are easily affected
[0012] The patent document with Chinese patent application number 201010513639.1 discloses a method for online derivatization and determination of amino acid content. The method also has the disadvantage of derivatization reaction, damages the chromatographic column, and the precision, accuracy and reproducibility of the method are easily affected by many conditions. the influence of etc.
As can be seen from the method, it still derivatizes arginine to reduce its polarity, and then uses a C18 chromatographic column for content determination. The method still cannot avoid the defects of derivatization, and the operation is also cumbersome
[0016] It can be seen from the existing technology that there is no suitable method that can simultaneously detect the content of ibuprofen and arginine in a simple and efficient manner

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039]Preliminary screening of chromatographic conditions for content detection. The ratio of acetonitrile to water or phosphate is shown in Table 1. Test sample: arginine reference substance solution. Detection wavelength: 199nm; flow rate: 1ml / min; column temperature: 30°C; injection volume: 5μl.

[0040] Table 1 Primary screening conditions and results

[0041] serial number Chromatographic column Acetonitrile water Phosphate solution main peak retention time 1 Cyano column 70 30 0 Not out of the peak 2 Cyano column 60 40 0 Not out of the peak 3 Cyano column 80 20 0 Not out of the peak 4 Cyano column 70 0 30 about 5 minutes 5 Cyano column 65 0 35 about 3 minutes 6 Amino column 70 30 0 Drift on the baseline and come out of Mantou Peak 7 Amino column 60 40 0 Drift on the baseline and come out of Mantou Peak 8 Amino column 80 20 0 Drift on the baseline and come out of Man...

Embodiment 2

[0043] Chromatographic conditions were optimized using a cyano column. Chromatographic column: Venusil XBP-CN cyano column (4.6mm×250mm, 5μm); use diammonium hydrogen phosphate as phosphate solution, see Table 2 for pH adjustment, flow rate and column temperature, detection wavelength: 199nm; injection volume: 5μl .

[0044] Table 2 Experimental design scheme of 3 factors and 2 levels of chromatographic conditions

[0045] serial number Proportion of acetonitrile (%) wavelength(nm) pH value Flow rate (ml / min) Column temperature (°C) 11 70 199 3.0 1.5 35 12 70 199 3.0 1.5 25 13 70 199 3.0 0.8 25 14 70 199 3.0 0.8 35 15 70 199 4.0 1.5 35 16 70 199 4.0 0.8 25 17 70 199 4.0 1.5 25 18 70 199 4.0 0.8 35

[0046] The retention time, asymmetry factor, number of theoretical plates, and column pressure of ibuprofen and arginine in the 8 groups of experiments were counted, and the result...

Embodiment 3

[0050] Chromatographic conditions were optimized using a cyano column. Chromatographic column: Venusil XBP-CN cyano column (4.6mm×250mm, 5μm); phosphate is added with 0.1% triethylamine, and then adjusted pH with phosphoric acid, see Table 4 for organic phase ratio, pH adjustment, flow rate, and column temperature. Detection wavelength: 199nm; injection volume: 5μl. Statistical retention time.

[0051]

[0052] Table 4 Experiment design scheme and results of chromatographic conditions

[0053] serial number Proportion of acetonitrile (%) wavelength(nm) pH value Flow rate (ml / min) Column temperature (°C) Ibuprofen retention time (min) Arginine retention time (min) 19 90 199 2.0 0.5 25 8.342 12.452 20 40 199 3.0 1.0 25 1.292 2.963 21 70 199 3.0 1.0 25 2.345 4.689 22 70 199 3.9 1.0 30 4.125 5.372 23 70 199 5.5 1.5 35 2.234 3.457 24 70 199 4.0 2.0 25 1.294 2.965 25 70 199 6.0 1...

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Abstract

The invention provides a method for simultaneous determination of content of ibuprofen and arginine in ibuprofen injection. In the method, a cyano column and high performance liquid chromatography are used for simultaneous determination of content of ibuprofen and arginine. According to the invention, tedious procedures in respective detection of ibuprofen and arginine are omitted, a cumbersome process for derivatization of arginine is avoided, and the method is fast and accurate and has good repeatability.

Description

technical field [0001] The invention relates to a method for measuring substance content, in particular to a method for simultaneously measuring the content of ibuprofen and arginine in ibuprofen injection, which belongs to the technical field of medicine. Background technique [0002] Ibuprofen injection was approved by the U.S. Food and Drug Administration (FDA) on June 11, 2009. The specifications are 400mg / 4ml, 800mg / 8ml, and the trade name is Caldolor. It is the first approved treatment for pain and fever. intravenous preparations. [0003] The water solubility of ibuprofen is very poor, in order to dissolve it in water, arginine with strong polarity and good water solubility is used to form a salt with ibuprofen, so as to improve the water solubility of ibuprofen. [0004] At present, the detection methods of related preparations and raw materials of ibuprofen are mainly based on titration and reversed-phase liquid chromatography. [0005] In the Chinese Pharmaco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 刘福利田建宣李慧英岳丽娜孟建赵晓雷张伟锋田学文李巍武永德
Owner JILIN SIHUAN PHARM CO LTD
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