Method for measuring concentration of canagliflozin in human plasma by LC-MS/MS

A technology of human plasma concentration, applied in the field of medical testing, can solve the problems of complicated operation steps and large amount of plasma, and achieve the effects of saving project cost, small consumption of plasma, and accurate and reliable results.

Inactive Publication Date: 2021-04-23
湖南泰新医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method is complicated in operation steps, needs nitrogen blowing to reconstitute, and consumes a large amount of plasma

Method used

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  • Method for measuring concentration of canagliflozin in human plasma by LC-MS/MS
  • Method for measuring concentration of canagliflozin in human plasma by LC-MS/MS
  • Method for measuring concentration of canagliflozin in human plasma by LC-MS/MS

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Experimental program
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Embodiment 1

[0103] 1. Solution preparation

[0104] Mobile phase A (10mM ammonium acetate aqueous solution)

[0105] Weigh about 0.7708g of ammonium acetate and dissolve it in 1L of ultrapure water, mix well and set aside.

[0106] Mobile phase B (acetonitrile)

[0107] Measure 2L of acetonitrile (Merck) in a 2L solvent bottle for use

[0108] Needle washing solution (methanol: water, 90:10, V / V)

[0109] Separately take 900mL of methanol and 100mL of ultrapure water and transfer them to an appropriate solvent bottle, mix well, and set aside.

[0110] Preparation of working fluid diluent (50% acetonitrile aqueous solution)

[0111] Separate 250ml of ultrapure water and 250ml of acetonitrile into an appropriate solvent bottle, and mix well.

[0112] Precipitating agent (acetonitrile)

[0113] Measure 500mL of acetonitrile into an appropriate solvent bottle for use.

[0114] 2. Standard solution preparation:

[0115] Preparation of standard reference substance stock solution

[011...

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Abstract

The invention belongs to the technical field of medicine detection, and particularly discloses a method for measuring the concentration of canagliflozin in human plasma through LC-MS/MS. The method has high specificity, can accurately measure the concentration of canagliflozin in plasma and is high in sensitivity, and the minimum plasma quantitation limit of canagliflozin is 50 ng/mL. According to the method, the linear range of a plasma standard curve of canagliflozin is 50-8000 ng/mL, and the intra-batch precision RSD and the inter-batch precision RSD are both smaller than +/-10%. The method is good in reproducibility and high in accuracy; and the method solves the problem of matrix effect, is not interfered by matrixes, hyperlipidemia matrixes and hemolytic matrixes, is not interfered by blood plasma of different crowds, and can be used for clinical large-batch sample analysis.

Description

technical field [0001] The invention relates to the technical field of medical detection, in particular to a method for measuring the concentration of canagliflozin in human plasma by LC-MS / MS. Background technique [0002] Canagliflozin, English name Canagliflozin, is a potent, reversible and highly selective human renal sodium glucose co-transporter (SGLT2) inhibitor originally developed by Johnson & Johnson. fluid excretion, thereby lowering blood sugar. In March 2013, it was approved for marketing by the US FDA. Log in to the US market; in November 2013, it was approved for marketing by the EU EMA; in July 2014, it was approved by the Japanese PMDA. At present, there are two registration certificate numbers for canagliflozin announced by my country's CFDA, both of which are from Janssen Pharmaceuticals. The specifications are 100mg and 300mg respectively. Canagliflozin is a new oral drug for the treatment of diabetes, which can effectively competitively inhibit sod...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/88
CPCG01N30/06G01N30/88
Inventor 黎明尹小丽
Owner 湖南泰新医药科技有限公司
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