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Method for separating related substances in loxoprofen or sodium salt thereof

A separation method and related substance technology, applied in the direction of material separation, analysis of materials, measuring devices, etc., can solve the problems of main peak tailing, impurity cannot be accurately detected, test solution cannot be filtered or centrifuged, etc., and achieve great benefits , reduce the cost of the experiment, and the reagents are simple and easy to obtain

Active Publication Date: 2020-03-24
HUNAN JIUDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been verified by our experiments that the use of this diluent will cause swelling of the gel patch dosage form, resulting in the inability to filter or centrifuge the test solution, and the mobile phase will cause the tailing of the main peak after replacement with pure organic phase methanol extraction, resulting in some Impurities cannot be accurately detected

Method used

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  • Method for separating related substances in loxoprofen or sodium salt thereof
  • Method for separating related substances in loxoprofen or sodium salt thereof
  • Method for separating related substances in loxoprofen or sodium salt thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Take loxoprofen sodium gel patch, cut 35cm 2 (containing loxoprofen sodium 25mg), chopped into 150ml Erlenmeyer flask, added 50ml methanol, weighed and ultrasonicated for 30min, cooled to room temperature and supplemented with methanol to make the concentration 0.5mg / ml, filtered to obtain Test solution:

[0041] Get need testing solution 1.0ml, dilute to 50ml with methanol as reference substance solution;

[0042] The 0.01mol / L sodium dihydrogen phosphate solution with methanol and phosphoric acid to adjust the pH value to 1.7 is the mobile phase, the volume ratio of sodium dihydrogen phosphate and methanol is 50:50, measure the reference substance solution and the test sample prepared above 10 μl of each solution was injected into the chromatograph, and the chromatogram was recorded.

[0043] Among them, the chromatographic conditions for the determination are that the specification of the chromatographic column is 4.6*250mm, 5um, preferably a C18 chromatographic co...

Embodiment 2

[0050] Take loxoprofen sodium gel patch, cut 35cm 2 (containing loxoprofen sodium 25mg), chopped into 150ml Erlenmeyer flask, added 50ml methanol, weighed and ultrasonicated for 30min, cooled to room temperature and supplemented with methanol to make the concentration 0.5mg / ml, filtered to obtain Test solution:

[0051] Get need testing solution 1.0ml, dilute to 50ml with methanol as reference substance solution;

[0052] The 0.01mol / L sodium dihydrogen phosphate solution with methanol and phosphoric acid to adjust the pH value to 2.5 is the mobile phase, the volume ratio of sodium dihydrogen phosphate and methanol is 50:50, measure the reference substance solution and the test sample prepared above 10 μl of each solution was injected into the chromatograph, and the chromatogram was recorded.

[0053]Among them, the chromatographic conditions for the determination are that the specification of the chromatographic column is 4.6*250mm, 5um, preferably a C18 chromatographic col...

Embodiment 3

[0060] Take loxoprofen sodium gel patch, cut 35cm 2 (containing loxoprofen sodium 25mg), chopped into 150ml Erlenmeyer flask, added 50ml methanol, weighed and ultrasonicated for 30min, cooled to room temperature and supplemented with methanol to make the concentration 0.5mg / ml, filtered to obtain Test solution:

[0061] Get need testing solution 1.0ml, dilute to 50ml with methanol as reference substance solution;

[0062] The 0.01mol / L sodium dihydrogen phosphate solution with methanol and phosphoric acid to adjust the pH value to 2.5 is the mobile phase, the volume ratio of sodium dihydrogen phosphate and methanol is 50:50, measure the reference substance solution and the test sample prepared above 10 μl of each solution was injected into the chromatograph, and the chromatogram was recorded.

[0063] Among them, the chromatographic conditions for the determination are that the specification of the chromatographic column is 4.6*250mm, 5um, preferably a C18 chromatographic co...

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Abstract

The invention discloses a method for separating related substances in loxoprofen or sodium salt thereof. According to the method, unique chromatographic conditions are used, and the related substancesin the loxoprofen sodium salt are successfully separated. According to the method, reversed-phase chromatography is used for detection, the peak shape is good, the degree of separation from adjacentchromatographic peaks is high, the research and development cost is saved, the experimental difficulty is reduced, and the reproducibility is good.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for separating related substances in loxoprofen sodium salt. Background technique [0002] Loxoprofen Sodium (Loxoprofen Sodium), the chemical name is 2-[4-(2-oxocyclopentane-1-ylmethyl)phenyl]sodium propionate dihydrate, CAS number: 80382-23- 6. The molecular formula is C 15 h 17 NaO 3 , the molecular weight is 268.28, and the structural formula is as follows: [0003] . [0004] Loxoprofen sodium was first developed by Japan's Daiichi Sankyo Co., Ltd., and this product has been included in the National Ninth Five-Year Plan and one of the recommended trial products for new product development in 2010. Loxoprofen sodium is an acrylic acid precursor non-steroidal anti-inflammatory drug, which itself has no pharmaceutical activity. After transdermal or oral administration and absorption, it will be converted into the active metabolite trans-OH body in the huma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89G01N30/06
CPCG01N30/06G01N30/89G01N2030/062
Inventor 谢超君文凤何莉王奕肖稳定郑霞辉
Owner HUNAN JIUDIAN PHARMA
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