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Method for determining concentration of serodosin and KMD-3213G in plasma by using liquid chromatography-mass spectrometry

A technology of KMD-3213G and silodosin, which is applied in the field of medicine, can solve the problems reported in the literature and achieve the effects of good peak shape, easy operation and high sensitivity

Inactive Publication Date: 2019-03-29
徐州立顺康达医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Silodosin has excellent medicinal value. At present, there is no literature report on the determination method of Silodosin and KMD-3213G

Method used

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  • Method for determining concentration of serodosin and KMD-3213G in plasma by using liquid chromatography-mass spectrometry
  • Method for determining concentration of serodosin and KMD-3213G in plasma by using liquid chromatography-mass spectrometry
  • Method for determining concentration of serodosin and KMD-3213G in plasma by using liquid chromatography-mass spectrometry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

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

[0034] 1. Experimental materials and analytical equipment

[0035] Silodosin (Analyte 1): Toronto Research Chemicals or equivalent or higher grade standard

[0036] KMD-3213G (analyte 2): TLC Pharmaceutical Standards or equivalent or higher grade standard

[0037] Silodosin-d4 (internal standard): TLC Pharmaceutical Standards or equivalent or higher grade standard

[0038] The reagents used are shown in Table 1 below:

[0039] Table 1 Reagent Details

[0040] Reagent name

level

manufacturer

Acetonitrile

HPLC

J. T. Baker

Ammonium acetate

HPLC

J. T. Baker

formic acid

ACS

Adamas

[0041] Note: Reagents of the same grade or higher can also be used

[0042] The analytical equipment used is shown in Table 2 below:

[0043] Table 2 Details of equipment used

[0044] components

type

manufacturer

Binaryp...

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PUM

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Abstract

The invention discloses a method for determining the concentration of serodosin and KMD-3213G in plasma by using liquid chromatography-mass spectrometry. The concentration of serodosin and KMD-3213G in the plasma is determined by using a liquid chromatography-mass spectrometry system; taking a sample to be tested first, and adding a certain amount of mixed organic solvent for extraction twice; after pretreatment, performing chromatographic column separation, and then detecting by using a mass spectrometry detector. The method for determining the concentration of serodosin and KMD-3213G in theplasma by using the liquid chromatography-mass spectrometry disclosed by the invention has the advantages of rapid, accurate, high sensitivity and simple operation, and provides a basis for determining the blood concentration of serodosin and KMD-3213G. According to the plasma standard curve of the method, the quantitative range of serodosin is 0.2-60 ng / mL, the quantitative range of KMD-3213G is0.2-40 ng / mL, and the intra-assay and inter-assay precisions RSDs are less than + / -15%, which is suitable for determining the concentration of serodosin and KMD-3213G in the plasma.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for determining the concentration of silodosin and KMD-3213G in blood plasma by liquid chromatography-mass spectrometry. Background technique [0002] Silodosin (Silodosin, also known as Silodosin) is an α1-receptor antagonist developed by Japan's Kissei Pharmaceutical Company, which can be used to treat symptoms associated with benign prostatic hyperplasia or hypertrophy. Japan's Jusheng Pharmaceutical Co., Ltd. and Daiichi Sankyo Pharmaceutical Co., Ltd. jointly applied for it, and it was first approved for marketing in Japan in May 2006. The trade name used is Urief. Subsequently, Jusheng and Daiichi Sankyo also authorized silodosin to Watson Pharmaceutical Company of the United States, which was approved by the US Food and Drug Administration (FDA) in August 2008 and launched in the United States. The silodosin capsule preparation imported by Japan's Da...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/06G01N30/88
Inventor 林明弘
Owner 徐州立顺康达医药科技有限公司
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