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: 2006-06-21
CHONGQING PHARMA RES INST +1
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  • 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

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  • 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] American Agilent 1100 high-performance liquid chromatography system and workstation; automatic sampling; CHIRALPAK-AD chiral chromatography column (250mm×4.6mm) as the separation column; UV 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] Get reagent blank solution and need testing solution respectively, carry out high performance liquid chromatography analysis according to above-mentioned conditions, record chromatogram, the result sees figure 1 , figure 2 .

[0036] figure 2 The chromatographic peak with a retention time of 17.222 minutes is...

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 image 3 .

[0040] image 3 It is proved 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 25mg 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 see Figure 4 , Figure 5 .

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

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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 CaF 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) -7-[...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/60B01J20/281G01N30/02
Inventor 杨成付晓泰黄玉明
Owner CHONGQING PHARMA RES INST
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