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Method for separating and determining related substances in ezetimibe tablet

A technology for related substances and ezetimibe, which is applied in the field of separation and determination of related substances in ezetimibe tablets, achieving the effects of good specificity, broad application prospects, and simple operation

Pending Publication Date: 2021-11-02
JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] So far, there is no literature report on the method for the determination of the above five ezetimibe-related substances

Method used

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  • Method for separating and determining related substances in ezetimibe tablet
  • Method for separating and determining related substances in ezetimibe tablet
  • Method for separating and determining related substances in ezetimibe tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] 1, instruments and conditions

[0067] Instrument: Liquid Chromatograph

[0068] Detector: UV detector

[0069] Columns: octadecyl silicone bile silica gel as filler (Hypersil BDS 150 × 4.6mm, 5 μm or) column)

[0070] Mobile phase (V: V): 0.05 mol / L of pelicate solution, acetonitrile, tetrahydrofuran is 65:25:10

[0071] Diluent (V: V): The volume ratio of glacial acetic acid, acetonitrile and water is 0.1: 60: 40

[0072] Test wavelength: 232nm

[0073] Column temperature: 25 ° C

[0074] Flow speed: 1.0ml / min

[0075] Inject volume: 30 μL.

[0076] 2, experimental steps

[0077] 2.1, use diluent to dissolve the containing folded wheat (concentration 1 mg / ml), related substance A, related substance B, related substance C, related substance D, related substance E, SYM-SSS / SYM-RRR 2 μg / ml Mixed solution, as a systematic solution;

[0078] 2.2, retrieving the right to fold the wheat powder is moderately, dissolved with a diluent, formulated into a solution of 10 mg...

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Abstract

The invention discloses a method for separating and determining related substances in ezetimibe tablets. The method comprises the following steps: (1) preparing a diluent; (2) preparing a mobile phase; (3) preparing a test solution; (4) preparing a contrast solution; (5) preparing a sensitivity solution; (6) preparing a system applicable solution; and (7) chromatographic analysis and determination: analyzing and determining the single impurity content and the total impurity content of the ezetimibe tablets according to a liquid chromatogram. According to the method, related substances in the ezetimibe tablet are separated and determined by adopting a high performance liquid chromatography, and the separation of ezetimibe and five impurities is realized. The method is high in sensitivity, capable of realizing baseline separation, good in specificity, accurate in impurity content determination, simple and convenient to operate, and good in separation measurement, and the separation degree between a main component and each impurity is greater than 1.5. The method can be used for quality control of ezetimibe and has a wide application prospect.

Description

Technical field [0001] The present invention belongs to the technical field of drug analysis, and more particularly to a method of separating a substance in the abbrenesses in the abbot. Background technique [0002] Compared with Ezetimibe, it is mainly used for the treatment of primary high cholesterolemia. It is also the only cholesterol absorbing inhibitor, which can simultaneously interfere with the cholesterol of the food source and the liver cycle in the liver cycle. The absorption of cholesterol does not have an effect on other nutrient components. The chemical name of 1- (4-fluorophenyl) -3 (R) - [3- (4-fluorophenyl) -3 (S)-hydroxypropyl] -4 (s)-(s)-(4-fluorophenyl) -3 (s)-(4-fluorophenyl) -4 (s)-( 4-hydroxyphenyl) -2-ruthenium (nitrogen hetericycloone) ketone, its chemical structure formula is as follows: [0003] [0004] In the process of relying on the multi-cloth synthesis, some related impurity materials such as by-products or intermediates or degradation product...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/86
CPCG01N30/02G01N30/8637G01N2030/027
Inventor 江永红丁月萍刘红刘蕾陶冬梅
Owner JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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