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Method for detecting sitagliptin and metformin in biological sample

A technology for metformin and biological samples, which is applied in the fields of drug chromatography and mass spectrometry to achieve the effect of rapid analysis and simple operation.

Inactive Publication Date: 2022-07-08
苏州旭辉生物医药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The original manufacturer of the drug is Merck, which was approved by the FDA in 2007 and was approved in China in 2012 under the name Currently, there is no method for the simultaneous detection of these two components, sitagliptin and metformin, creating a technical gap in this regard

Method used

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  • Method for detecting sitagliptin and metformin in biological sample
  • Method for detecting sitagliptin and metformin in biological sample
  • Method for detecting sitagliptin and metformin in biological sample

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Embodiment 1

[0040] A method for detecting sitagliptin and metformin in a biological sample, comprising the following steps:

[0041] (1) Chromatographic conditions:

[0042] Chromatographic column: ZORBAX SB-C184.6*150mm, 3.5μm, Agilent;

[0043] Mobile phase: 0.1% formic acid aqueous solution (containing 5mM ammonium acetate), B-acetonitrile;

[0044] Flow rate: 1.00ml / min;

[0045] Column temperature: 40℃;

[0046] Injection volume: 3.00μl;

[0047] Isocratic procedure: mobile phase ratio: A:B=30:70

[0048] MS conditions:

[0049] Electrospray positive ion mode;

[0050] Spray voltage: 5500V;

[0051] Curtain air (CUR): 20psi;

[0052] Collision Excited Fragmentation (CAD): 10;

[0053] Atomizing gas (GS1): 55psi

[0054] Auxiliary gas (GS2): 55psi

[0055] Scanning Mode: Multiple Reaction Monitoring (MRM):

[0056]

[0057](2) Preparation of standard song working solution: Precisely weigh 10.09 mg of sitagliptin (mass correction coefficient 99.1%), place it in a 15 mL p...

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Abstract

The invention provides a method for detecting sitagliptin and metformin in a biological sample, which adopts an LC-MS / MS method for detection, and the chromatographic conditions are as follows: a chromatographic column is a ZORBAX SB-C18 4.6 * 150mm, 3.5 [mu] m chromatographic column; mass spectrum conditions are as follows: API 4000 (ESI source) mass spectrum, positive ions, ion injection voltage of 5500V, temperature of 550 DEG C, atomization gas pressure of 55psi, declustering voltage pressure of 55psi, gas curtain gas pressure of 20psi, and scanning mode of multiple reaction monitoring (MRM). Mobile phases: A-0.1% formic acid aqueous solution (containing 5mM ammonium acetate) and B-acetonitrile; the flow rate is 1.00 ml / min; the column temperature is 40 DEG C; and the sample size is 3.00 [mu] l. The method disclosed by the invention can be used for exclusively, sensitively and quickly measuring the concentration of sitagliptin and metformin in human plasma, and is mainly suitable for measuring the content of sitagliptin and metformin in tablets.

Description

technical field [0001] The invention belongs to the field of drug chromatography and mass spectrometry analysis, relates to a detection method of chemicals, in particular to a detection method of sitagliptin and metformin in biological samples. Background technique [0002] Sitagliptin is a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor. Metformin is a biguanide oral hypoglycemic drug. Combination of blood sugar drugs, combined with diet and exercise therapy, is used for patients with type 2 diabetes who are still poorly controlled by metformin monotherapy or are receiving combined therapy of the two. The original manufacturer of the drug is Merck & Co., which was approved by the FDA in 2007 and was approved in China under the trade name in 2012. At present, there is no method for the simultaneous detection of the two components of sitagliptin and metformin, resulting in a technical gap in this regard. SUMMARY OF THE INVENTION [0003] Technical ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/54G01N30/72
CPCG01N30/02G01N30/06G01N30/54G01N30/72
Inventor 李汀芷
Owner 苏州旭辉生物医药有限公司