Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Method for separating and determining pitavastatin and its optical isomer by means of liquid chromatography

A technology for optical isomers and determination methods, applied in the field of analytical chemistry, can solve unreliable problems, achieve the effects of improving symmetry, ensuring stability, and controlling quality

Inactive Publication Date: 2008-02-27
CHONGQING PHARMA RES INST +1
View PDF5 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the results determined by ULTRON ES-OVM (150mm×4.6mm) chiral chromatographic column are unreliable, so that reliable and effective quality control of pitavastatin calcium cannot be carried out

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Method for separating and determining pitavastatin and its optical isomer by means of liquid chromatography
  • Method for separating and determining pitavastatin and its optical isomer by means of liquid chromatography
  • Method for separating and determining pitavastatin and its optical isomer by means of liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Instruments and Conditions

[0032] U.S. Agilent 1100 high-performance liquid chromatography system and workstation; automatic sample injection; with CHIRALPAK-AD chiral chromatography column (250mm × 4.6mm) as the separation column; ultraviolet detection wavelength: 245nm; mobile phase: n-hexane-ethanol solution (containing 1.0% trifluoroacetic acid) (92:8) as mobile phase; column temperature 40°C. The injection volume was 10 μl.

[0033] Experimental procedure

[0034] Take about 25mg of pitavastatin calcium racemate, put it in a 50ml measuring bottle, add ethylene glycol dimethyl ether to dissolve and dilute to the mark, shake well, and use it as the test solution.

[0035] Respectively take reagent blank solution and need testing solution, carry out high performance liquid chromatography analysis according to above-mentioned conditions, record chromatogram, the result is shown in Fig. 1, Fig. 2.

[0036] The chromatographic peak of retention time 17.222 minutes i...

Embodiment 2

[0038] Take about 25mg of pitavastatin calcium, put it in a 50ml measuring bottle, add ethylene glycol dimethyl ether to dissolve and dilute to the mark, shake well, and use it as the test solution.

[0039] Get need testing solution, carry out high performance liquid chromatography analysis according to the condition of embodiment 1, record chromatogram, the results are shown in Fig. 3.

[0040] Figure 3 proves that the optical purity of pitavastatin calcium meets the requirements of raw materials, and this method can be used for quality monitoring of pitavastatin calcium.

Embodiment 3

[0042] Take an appropriate amount of pitavastatin calcium tablets, approximately equivalent to 25 mg of pitavastatin calcium, put it in a 50ml measuring bottle, add an appropriate amount of ethylene glycol dimethyl ether, shake to dissolve, dilute to the mark with ethylene glycol dimethyl ether, and shake well , filtered, and the filtrate was used as the test solution. Get need testing solution, carry out high performance liquid chromatography analysis according to the condition of embodiment 1, and carry out adjuvant blank test with method, the results are shown in Fig. 4, Fig. 5.

[0043] Figure 4 proves that the adjuvant blank does not interfere with the determination, and Figure 5 shows that this method can be used for quality monitoring of preparations containing pitavastatin calcium.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
wavelengthaaaaaaaaaa
Login to View More

Abstract

The invention discloses a segregation detection method of drapery tartan calcium and optical isomer (impurity), which is characterized by the following: adapting high effective gas-chromatography or high effective gas-chromatography mass spectrography to detect the optical isomer of drapery tartan calcium; segregating the drapery tartan calcium and optical isomer of drapery tartan calcium.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for separating and measuring pitavastatin calcium and its optical isomers by liquid chromatography. Background technique [0002] Pitavastatin Calcium is a blood lipid-lowering drug developed and marketed by a Japanese company with the molecular formula C 50 h 46 C a f 2 N 2 o 8 , its chemical name is: bis-[(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy- 6-heptenoic acid] calcium salt, pitavastatin calcium is the active ingredient. The pitavastatin calcium molecule contains two chiral carbon atoms, and four optical isomers with different stereo configurations will be produced simultaneously during chemical synthesis. In addition to pitavastatin calcium, the other three optical isomers are listed as impurities of pitavastatin calcium; the chemical names of the optical isomer impurities of pitavastatin calcium are: bis-[(3S, 5R, 6E) -...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/60B01J20/281G01N30/02
Inventor 杨成付晓泰黄玉明
Owner CHONGQING PHARMA RES INST
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com