A method for the separation and determination of rosuvastatin tert-butyl ester and its optical isomers by liquid chromatography

A technology for rosuvastatin tert-butyl ester and optical isomers, which is applied in the field of separation and determination of rosuvastatin tert-butyl ester and its optical isomers by liquid chromatography, achieving good specificity, short analysis time and high sensitivity high effect

Active Publication Date: 2021-06-22
ANHUI QINGYUN PHARMA & CHEM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The separation of optical isomers of compounds containing multiple chiral carbon atoms has always been a difficult point in the quality control of chiral drugs. The quality control of rosuvastatin calcium has practical significance, but there is no report on the determination of optical isomers of rosuvastatin tert-butyl ester in the existing patent

Method used

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  • A method for the separation and determination of rosuvastatin tert-butyl ester and its optical isomers by liquid chromatography
  • A method for the separation and determination of rosuvastatin tert-butyl ester and its optical isomers by liquid chromatography
  • A method for the separation and determination of rosuvastatin tert-butyl ester and its optical isomers by liquid chromatography

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0033] A method for liquid chromatography separation and determination of rosuvastatin tert-butyl ester and optical isomers thereof, said method comprising the steps of:

[0034] S1. Prepare racemic mixture stock solution: add mobile phase to rosuvastatin tert-butyl ester racemic mixture, shake well to obtain racemic mixture stock solution;

[0035] S2. Prepare the system suitability test solution: add the racemic mixture stock solution and mobile phase to the rosuvastatin tert-butyl ester reference substance in sequence, and shake well to obtain the system suitability test solution;

[0036] S3, preparing the test solution: add the mobile phase to the rosuvastatin tert-butyl ester test product, shake well to obtain the test solution;

[0037] S4, chromatographic determination: take a blank solution, inject it into a liquid chromatograph, and record the chromatogram Figure I ; Take the system suitability test solution, inject it into the liquid chromatograph, and record the c...

Embodiment 2

[0039] A method for liquid chromatography separation and determination of rosuvastatin tert-butyl ester and optical isomers thereof, said method comprising the steps of:

[0040] S1. Prepare racemic mixture stock solution: add mobile phase to rosuvastatin tert-butyl ester racemic mixture, shake well to obtain racemic mixture stock solution;

[0041] S2. Prepare the system suitability test solution: add the racemic mixture stock solution and mobile phase to the rosuvastatin tert-butyl ester reference substance in sequence, and shake well to obtain the system suitability test solution;

[0042] S3, preparing the test solution: add the mobile phase to the rosuvastatin tert-butyl ester test product, shake well to obtain the test solution;

[0043] S4, chromatographic determination: take a blank solution, inject it into a liquid chromatograph, and record the chromatogram Figure I ; Take the system suitability test solution, inject it into the liquid chromatograph, and record the c...

Embodiment 3

[0046] A method for liquid chromatography separation and determination of rosuvastatin tert-butyl ester and optical isomers thereof, said method comprising the steps of:

[0047] S1. Prepare racemic mixture stock solution: add mobile phase to rosuvastatin tert-butyl ester racemic mixture, shake well to obtain racemic mixture stock solution;

[0048] S2. Prepare the system suitability test solution: add the racemic mixture stock solution and mobile phase to the rosuvastatin tert-butyl ester reference substance in sequence, and shake well to obtain the system suitability test solution;

[0049] S3, preparing the test solution: add the mobile phase to the rosuvastatin tert-butyl ester test product, shake well to obtain the test solution;

[0050] S4, chromatographic determination: take a blank solution, inject it into a liquid chromatograph, and record the chromatogram Figure I; Take the system suitability test solution, inject it into the liquid chromatograph, and record the ch...

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Abstract

The invention discloses a method for separating and measuring rosuvastatin tert-butyl ester and its optical isomers by liquid chromatography: preparing a racemic mixture stock solution; preparing a system applicability test solution; preparing a test solution; chromatography Determination: Take the blank solution, inject it into the liquid chromatograph, and record the chromatogram I; take the system suitability test solution, inject it into the liquid chromatograph, and record the chromatogram II; take the test solution, inject it into the liquid chromatograph, and record the chromatogram Ⅲ, calculated according to the analysis of chromatograms Ⅰ, Ⅱ, Ⅲ. The invention has short analysis time, good specificity and high sensitivity, and can quickly, effectively and accurately separate and detect rosuvastatin tert-butyl ester and its optical isomers, thereby better controlling the final product rosuvastatin The mass of tert-butyl calcium.

Description

technical field [0001] The invention relates to the technical field of silodosin determination, in particular to a liquid chromatography separation and determination method for rosuvastatin tert-butyl ester and its optical isomers. Background technique [0002] Rosuvastatin calcium is a selective HMG-CoA reductase inhibitor, which has the effect of regulating blood lipids. Developed by AstraZeneca, rosuvastatin calcium tablets have been launched in the United States, Japan, Europe, China and other countries and regions under the trade name "CRESTOR". [0003] Rosuvastatin tert-butyl ester is the key intermediate of rosuvastatin calcium, and its molecular formula is C 26 h 36 FN 3 o 6 S, the chemical name is (6E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3R, 5S)-3,5-dihydroxyheptane-6, its chemical structural formula is as follows: [0004] [0005] The molecule of rosuvastatin tert-butyl ester contains two chiral carbon atoms,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 黄欢黄庆国施亚琴
Owner ANHUI QINGYUN PHARMA & CHEM
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