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Method for determining pitavastatin calcium content through HPLC method

A technology of pitavastatin calcium and pitavastatin, which is applied in the field of pitavastatin calcium determination, can solve the problems of no report on the determination of pitavastatin calcium content, and achieve the effects of low cost, high accuracy and simple method

Inactive Publication Date: 2019-04-05
ANHUI QINGYUN PHARMA & CHEM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Pitavastatin calcium belongs to the 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-Co-A) reductase inhibitor, is a kind of blood lipid lowering drug, developed and marketed by a Japanese company, the molecular formula is 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, that is, pitavastatin calcium is the active ingredient, but there is no report about the determination of pitavastatin calcium content in the existing patent

Method used

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  • Method for determining pitavastatin calcium content through HPLC method
  • Method for determining pitavastatin calcium content through HPLC method

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Embodiment 1

[0030] A method for measuring pitavastatin calcium content by HPLC, said method comprising the steps of:

[0031] S1. Prepare internal standard solution: add acetonitrile and water mixed solution to butylparaben, shake well to obtain internal standard solution;

[0032] S2, prepare reference substance solution: add the mixed solution of acetonitrile and water, internal standard solution successively to pitavastatin methylbenzylamine, shake well, obtain reference substance solution;

[0033] S3, preparation need testing solution: in pitavastatin calcium, add the mixed solution of acetonitrile and water, internal standard solution successively, shake up, get need testing solution;

[0034] S4, chromatographic determination: take the reference substance solution, inject it into the HPLC instrument, and record the chromatogram Figure I ; Take the test solution, inject it into the HPLC instrument, and record the chromatogram Figure II , according to the color spectrum Figure I ...

Embodiment 2

[0036] A method for measuring pitavastatin calcium content by HPLC, said method comprising the steps of:

[0037] S1. Prepare internal standard solution: add acetonitrile and water mixed solution to butylparaben, shake well to obtain internal standard solution;

[0038] S2, prepare reference substance solution: add the mixed solution of acetonitrile and water, internal standard solution successively to pitavastatin methylbenzylamine, shake well, obtain reference substance solution;

[0039] S3, preparation need testing solution: in pitavastatin calcium, add the mixed solution of acetonitrile and water, internal standard solution successively, shake up, get need testing solution;

[0040] S4, chromatographic determination: take the reference substance solution, inject it into the HPLC instrument, and record the chromatogram Figure I ; Take the test solution, inject it into the HPLC instrument, and record the chromatogram Figure II , according to the color spectrum Figure I ...

Embodiment 3

[0043] A method for measuring pitavastatin calcium content by HPLC, said method comprising the steps of:

[0044] S1. Prepare internal standard solution: add acetonitrile and water mixed solution to butylparaben, shake well to obtain internal standard solution;

[0045] S2, prepare reference substance solution: add the mixed solution of acetonitrile and water, internal standard solution successively to pitavastatin methylbenzylamine, shake well, obtain reference substance solution;

[0046] S3, preparation need testing solution: in pitavastatin calcium, add the mixed solution of acetonitrile and water, internal standard solution successively, shake up, get need testing solution;

[0047] S4, chromatographic determination: take the reference substance solution, inject it into the HPLC instrument, and record the chromatogram Figure I ; Take the test solution, inject it into the HPLC instrument, and record the chromatogram Figure II , according to the color spectrum Figure I ...

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Abstract

The invention discloses a method for determining pitavastatin calcium content through an HPLC method, comprising the steps of preparing an internal standard solution; preparing a reference substance solution; preparing a sample solution; and performing chromatographic determination: taking the reference substance solution, injecting the solution into an HPLC instrument, and recording a chromatogram I; taking the sample solution, injecting the solution into the HPLC instrument, recording a chromatogram II, and performing analysis and calculation according to the chromatograms I and II. According to the method in the invention, the HPLC method is used for determining the content of pitavastatin calcium, and the method in the invention is simple and convenient, high in accuracy and low in cost, can be used for quality control of pitavastatin calcium, and is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of determination of pitavastatin calcium, in particular to a method for determining the content of pitavastatin calcium by HPLC. Background technique [0002] Pitavastatin Calcium is the first fully synthetic HMG-Co-A reductase inhibitor jointly developed by Nissan Chemical and Kowa Co., Ltd. -A reductase liver enzyme inhibition to reduce the ability of the liver to produce cholesterol, so as to improve the elevated blood cholesterol level, mainly used to treat patients with hypercholesterolemia and familial hypercholesterolemia, its lipid-lowering effect is very good Well, the most powerful lipid-lowering drug available to date. [0003] Pitavastatin calcium belongs to the 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-Co-A) reductase inhibitor, is a kind of blood lipid lowering drug, developed and marketed by a Japanese company, the molecular formula is C 50 h 46 CaF 2 N 2 o 8 , its chemical name is: bi...

Claims

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Application Information

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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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