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Quantitative analysis method for mirabegron in human plasma

A quantitative analysis, human plasma technology, applied in the field of biological analysis, can solve the problems of poor practicability, troublesome operation, etc., and achieve the effects of strong specificity, reduced impact, and improved detection efficiency

Pending Publication Date: 2021-11-26
济南智同医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] In order to solve the shortcomings or deficiencies of troublesome operation and poor practicability in the prior art, the present invention adopts the scheme of protein precipitation sample pretreatment, thereby realizing the quantitative determination of mirabegron in human plasma with high sensitivity and high throughput. Purpose

Method used

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  • Quantitative analysis method for mirabegron in human plasma
  • Quantitative analysis method for mirabegron in human plasma
  • Quantitative analysis method for mirabegron in human plasma

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Embodiment 1

[0056] Embodiment 1: a kind of quantitative analysis method of mirabegron in human plasma

[0057] 1. Experimental materials and instruments

[0058] 1. Drugs and reagents: mirabegron (TLC); mirabegron-d5 (TLC); methanol (chromatographically pure, OCEANPAK); formic acid (chromatographically pure, Aladdin); ammonium formate (chromatographically pure, Aladdin); Sodium chloride (AR grade, Tianjin Damao); purified water (Wahaha).

[0059] 2. Instruments: The names and specifications of the specific instruments are shown in Table 6 below.

[0060] Table 6 Names and Specifications of Specific Instruments

[0061]

[0062] 2. Liquid quality conditions

[0063] 1. Liquid Chromatography Conditions

[0064] Chromatographic column: Synergi Hydro-RP C18 (4.0μm, 2.0*50mm);

[0065] Mobile phase: mobile phase A: (water / formic acid / 5M-AF=100 / 0.1 / 0.1), mobile phase B: (methanol / water / formic acid / 5M-AF=90 / 10 / 0.1 / 0.1);

[0066] Column oven temperature: 40°C;

[0067] Flow rate: 0.3ml / ...

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Abstract

The invention discloses a quantitative analysis method for mirabegron in human plasma, and belongs to the field of biological analysis. According to the method, a human plasma sample is treated by adopting protein precipitation, mirabegron -d5 is taken as an internal standard, and the content of mirabegron in human plasma is detected by adopting a high performance liquid chromatography-mass spectrometry (LC-MS / MS) method. The detection method provided by the invention has the advantages of high sensitivity, strong specificity, high stability and high recovery rate, can meet the requirement of the recovery rate, and can also improve the detection efficiency. Besides, the detection method is high in reproducibility and short in analysis time, can meet the detection requirement of the concentration of mirabegron in human plasma, and can be used for pharmacokinetic research and bioequivalence research of mirabegron sustained release tablets.

Description

technical field [0001] The invention belongs to the field of biological analysis, and in particular relates to a method for quantitatively detecting mirabegron in plasma by liquid chromatography-mass spectrometry (LC-MS / MS). Background technique [0002] Mirabegron is an effective selective β3 adrenergic receptor agonist, clinically applicable to the treatment of urgency, frequency and urge urinary incontinence caused by overactive bladder. After oral administration of mirabegron in healthy volunteers, maximum plasma concentrations are reached approximately 3.5 hours (C max ). The absolute bioavailability was 29% at a dose of 25 mg, increasing to 35% at a dose of 50 mg. Give 50mg mirabegron after a high-fat meal, C max and AUC were reduced by 45% and 17%, respectively. When taken with a low-fat meal, Mirabegron C max and AUC were reduced by 75% and 51%, respectively. Mirabegron is metabolized by several pathways, including dealkylation, oxidation, (direct) glucuronida...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/72G01N30/34G01N30/06G01N30/04G01N30/86G01N30/88
CPCG01N30/02G01N30/72G01N30/34G01N30/06G01N30/04G01N30/8634G01N30/88G01N2030/062G01N2030/045G01N2030/8822
Inventor 李晋刘少超韩合敬
Owner 济南智同医药科技有限公司
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