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Detection method for related substances of ebiprazole starting material

A detection method and technology for related substances, which are applied in measurement devices, material separation, analysis of materials, etc., can solve problems such as incomplete detection and control of impurities, and achieve the effects of suitable detection time, reliable results and easy operation.

Active Publication Date: 2019-09-06
CHENGDU BAIYU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] Manufacturers in the industry usually use the TLC method (thin layer chromatography) to control the quality of the product when the ebiprazole starting material 1 (7-hydroxy-2-quinolone) leaves the factory, and use the TLC method to determine the ebiprazole starting material 1 When containing related substances, specific impurities such as A1-1, A1-2, A1-3, and A1-4 in the product preparation process cannot be completely detected and controlled. We can only simply observe the size of the color spots on the product and impurities, let alone Accurate quantification of individual impurities

Method used

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  • Detection method for related substances of ebiprazole starting material
  • Detection method for related substances of ebiprazole starting material
  • Detection method for related substances of ebiprazole starting material

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Experimental program
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Effect test

Embodiment 1

[0063] Embodiment 1 Detection method of the present invention

[0064](1) Preparation of impurity reference substance solution Take 3mg of each of the related substances A1-1, A1-2, A1-3, and A1-4, add diluent to dissolve and set the volume to 100mL, shake well, and use it as impurity mixed stock solution; precision Measure 5mL of impurity mixed stock solution, place it in a 50mL measuring bottle, add diluent to make up to the mark, shake well, and use it as the impurity reference substance mixed solution.

[0065] (2) Preparation of the test solution Weigh 7.5mg of this product, place it in a 25mL measuring bottle, add diluent to dissolve and dilute to the mark, shake well, and use it as the test solution.

[0066] (3) Determination method: Accurately measure 20 μl each of the test solution and the impurity reference solution, inject them into the liquid chromatograph respectively, and record the chromatograms. The chromatographic conditions are as follows:

[0067] Chromat...

Embodiment 2

[0075] Embodiment 2 detection method process screening of the present invention

[0076] 1. Determine the detection wavelength

[0077] Precisely weigh the appropriate amount of ebiprazole starting material 1 and impurities A1-1, A1-2, A1-3, and A1-4, and use solvent (methanol) to prepare a sample and impurity reference solution containing 5 μg per 1 mL ,spare.

[0078] The test solution of the above-mentioned ebiprazole starting material 1 and the reference solution of each impurity were scanned in the range of 200-400nm, and the results are shown in Table 1.

[0079] Table 1

[0080] No. Peak wavelength(nm) the peak Valley wavelength(nm) valley Starting material 1 213.2 1.515 335 0.364 Impurity A1-1 215.2 1.033 278.6 0.104 Impurities A1-2 216.8 1.26 239.4 0.26 Impurities A1-3 216 1.43 239.6 0.264 Impurities A1-4 213.2 0.58 268.8 0.082

[0081] The results showed that ebiprazole starting material 1 and rela...

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Abstract

The invention discloses a detection method of brexpiprazole starting material related substances. The detection method comprises steps as follows: a, preparation of a reference substance solution; b, measurement of the reference substance solution; c, preparation of a test solution; d, measurement of the test solution. With the adoption of the detection method of brexpiprazole starting material related substances, through screening with multiple processes, impurities A1-1, A1-2, A1-3 and A1-4 in a brexpiprazole starting material 7-hydroxy-2-quinolone can be effectively separated and detected, the specificity is high, detection results are accurate and reliable, and the method has multiple advantages of being high in precision, good in stability, good in repeatability, convenient to operate, shorter in time and the like. Compared with existing methods, the method has the advantages that various impurities of samples can be measured more comprehensively, the detection time is appropriate, the results are more reliable, and the method is suitable for popularization and application.

Description

technical field [0001] The invention relates to a detection method for related substances of ebiprazole starting materials. Background technique [0002] Ebiprazole is an antipsychotic drug used to treat schizophrenia. The medicinal chemical, called Brexpiprazole, is also approved as an adjunctive treatment for major depressive disorder (MDD), a serious psychiatric disorder that causes persistent sadness, frustration or anger. Schizophrenia is a chronic, severe and disabling brain disorder that can cause delusions and hallucinations. According to the National Institute of Mental Health, the disorder affects about 1 percent of Americans. At its worst, MDD can lead to suicide, killing around 1 million people a year, according to the World Health Organization. The drug was launched in the U.S. market by Otsuka Pharmaceutical Company in August 2015, and is currently not listed in China. As the intermediate product in the synthesis process of this product, the quality of the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 宋务雄孙毅
Owner CHENGDU BAIYU PHARMA CO LTD
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