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Method for determining concentration of rosuvastatin in blood plasma through liquid chromatography-mass spectrometry

A technology of rosuvastatin and liquid mass spectrometry, which is applied in the field of determination of rosuvastatin concentration in plasma by liquid mass spectrometry, can solve the problems of speed, accuracy, sensitivity, and selectivity to be improved, and achieve high sensitivity and specificity Strong performance and good peak shape

Inactive Publication Date: 2021-06-04
徐州立兴佳正医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the speed, precision, sensitivity and selectivity of the existing methods for the determination of rosuvastatin need to be improved

Method used

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  • Method for determining concentration of rosuvastatin in blood plasma through liquid chromatography-mass spectrometry
  • Method for determining concentration of rosuvastatin in blood plasma through liquid chromatography-mass spectrometry
  • Method for determining concentration of rosuvastatin in blood plasma through liquid chromatography-mass spectrometry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0033] Example: Human K 2 Determination of Rosuvastatin Concentration in EDTA Plasma

[0034] 1. Experimental materials and analytical equipment

[0035] Rosuvastatin (analyte): TLC Pharmaceutical Standards or equivalent or higher grade standard

[0036] Rosuvastatin-d6 (internal standard): TLC Pharmaceutical Standards or the same or higher grade standard

[0037] The reagents used are shown in Table 1 below:

[0038] Table 1 Reagent Details

[0039] Reagent name level manufacturer Methanol (MeOH) HPLC J. T. Baker Formic acid (FA) ACS Adamas Acetonitrile (ACN) HPLC J. T. Baker Potassium dihydrogen phosphate (KH 2 PO 4 )

HPLC Adamas Methyl tert-butyl ether (MTBE) HPLC MREDA

[0040] Note: Reagents of the same grade or higher can also be used

[0041] The analytical equipment used is shown in Table 2 below:

[0042] Table 2 Details of equipment used

[0043]

[0044] The same LC / MS / MS system can also be...

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Abstract

The invention discloses a method for determining the concentration of rosuvastatin in plasma by liquid chromatography-mass spectrometry, which adopts a liquid chromatography-mass spectrometry system for determination and comprises the following steps of: firstly taking a sample to be detected, adding a certain amount of mixed organic solvent for extraction and pretreatment, performing separating by a chromatographic column, and performing detecting by a mass spectrometry detector. The method disclosed by the invention is rapid, accurate, high in sensitivity and simple and convenient to operate, and provides a basis for measuring the blood concentration of rosuvastatin; the linear range of the plasma standard curve of the method is 0.05-40ng / mL, the intra-batch and inter-batch precision RSD is less than + / -15%, and the method is suitable for measuring the concentration of rosuvastatin in plasma.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular relates to a method for determining a drug, in particular to a method for determining the concentration of rosuvastatin in blood plasma by liquid mass spectrometry. Background technique [0002] Rosuvastatin is suitable for primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) whose dyslipidemia cannot be adequately controlled by diet control and other non-drug treatments (such as: exercise therapy, weight loss). ) or mixed dyslipidemia (type IIb). Rosuvastatin is also indicated for patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid-lowering measures (eg, LDL-depletion therapy), or when these are not indicated. [0003] Rosuvastatin is a selective and competitive HMG-CoA reductase inhibitor. HMG-CoA reductase is the rate-limiting enzyme in the conversion of 3-hydroxy-3-methylglutaryl-CoA to mevalon...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/06G01N30/88G01N2030/027G01N2030/062G01N2030/8822
Inventor 范志鸿
Owner 徐州立兴佳正医药科技有限公司
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