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Method for determining concentration of dapagliflozin in plasma

A plasma and concentration technology, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of low detection accuracy, large amount of plasma, long detection time, etc., and achieve the effect of improving sensitivity, strong specificity and high recovery rate

Pending Publication Date: 2021-11-05
SUZHOU SCI&TECH TOWN HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Complex pre-processing methods reduce the efficiency of detection
In addition, the existing technology also has disadvantages such as large amount of plasma consumption, long detection time, and low detection accuracy.
[0005] Domestically, there is no literature report on the analysis method of dapagliflozin concentration in human plasma after oral administration of dapagliflozin tablets or sustained-release tablets

Method used

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  • Method for determining concentration of dapagliflozin in plasma
  • Method for determining concentration of dapagliflozin in plasma
  • Method for determining concentration of dapagliflozin in plasma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: Determination of Dapagliflozin concentration in human plasma;

[0030] 1. Experimental materials and instruments

[0031] Dapagliflozin reference substance: provided by AstraZeneca Pharmaceuticals LP (AstraZeneca), batch number: AOLH000074; diazepam reference substance: provided by China National Institutes for Food and Drug Control, batch number: 171225-201805; test water: ultrapure water; Acetonitrile: chromatographically pure (Merck Company); ammonium acetate: analytically pure (Sinopharm Chemical Reagent Co., Ltd.).

[0032] API4000 LC / MS / MS coupled instrument (AB Scisex, USA), chromatographic workstation: Analyst 1.6; Mettler XS 105DU electronic balance (Mettler, Switzerland); Eppendorf Centrifuge 5424R high-speed low-temperature centrifuge (Eppendorf, Germany); KDC-2046 low-speed refrigerated centrifuge (Anhui Zhongke Zhongjia Scientific Instrument Co., Ltd.); Millipore Drict-Q5 ultrapure water machine (Millipore, France).

[0033] 2. Liquid condit...

Embodiment 2

[0057] Embodiment 2: Determination of the concentration of dapagliflozin in the plasma of female subjects;

[0058] Referring to Example 1, 1 healthy female subject took Dapagliflozin Tablets 10 mg on an empty stomach, and took it with 240 mL of warm water; 3 mL of peripheral venous blood was collected 3 hours after administration, injected into a heparin tube, and centrifuged (4000 r min -1 , 5min), draw 200 μL of subject’s plasma sample, and accurately add internal standard 500ng·mL -1 50 μL of diazepam solution was vortexed for 10 s, 510 μL of acetonitrile was added to precipitate protein, vortexed for 1 min, and centrifuged at 15,000 rpm and 4° C. for 10 min. Draw 400 μL of supernatant into the injection bottle, add 200 μL of deionized water, draw 50 μL of the mixed solution and inject. The results showed that after 5 hours of taking Dapagliflozin Tablets 10 mg on an empty stomach, the plasma Darpagliflozin content in a healthy female subject was 140.3 ng·mL -1 .

Embodiment 3

[0059] Embodiment 3: Determination of the concentration of dapagliflozin in the plasma of the experimenter 48h after administration;

[0060] Referring to Example 1, 1 healthy male subject took Dapagliflozin Tablets 10 mg on an empty stomach, and took it with 240 mL of warm water; 48 hours after administration, 3 mL of peripheral venous blood was collected, injected into a heparin tube, and centrifuged (4000 r min -1 , 5min), draw 200 μL of subject’s plasma sample, and accurately add internal standard 500ng·mL -1 50 μL of diazepam solution was vortexed for 10 seconds, 510 μL of acetonitrile was added to precipitate protein, vortexed for 1 min, and centrifuged at 15000 rpm and 4° C. for 10 min. Draw 400 μL of the supernatant into the injection bottle, add 200 μL of deionized water, and draw 50 μL of the mixed solution for injection. The results showed that 48 hours after oral administration of Dapagliflozin Tablets 10mg on an empty stomach, the content of Dapagliflozin in the ...

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Abstract

The invention provides a method for determining the concentration of dapagliflozin in blood plasma, which comprises the following steps: pretreating a blood plasma sample, performing liquid chromatography separation on the pretreated blood plasma sample, performing mass spectrometry determination, calculating and the like. Compared with the prior art, the method has the following advantages: (1) dapagliflozin and acetate ions form charged negative ions, so the Rayleigh limit can be easily reached at the ion source, and coulomb explosion is further realized, so that the sensitivity is improved; (2) the pretreatment method is simple and convenient; (3) the specificity is high; (4) the sensitivity is high, and the lowest limit of quantitation of plasma is 1.0 ng.mL <-1 >; (5) no matrix effect exists; and (6) the method is rapid, simple and convenient to operate, accurate, high in sensitivity and low in detection limit. A basis is provided for clinical blood drug concentration determination of dapagliflozin, and the dapagliflozin is used for research, development and clinical application of new drugs. The linear range of a plasma standard curve of the method is 1.0-4000 ng.mL <-1>, and the intra-batch and inter-batch precision RSD is less than 15%.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and relates to a method for analyzing and measuring drugs in vivo, in particular to a method for measuring the concentration of dapagliflozin in blood plasma. Background technique [0002] Sodium-glucose cotransporter 2 (SGLT2), expressed in proximal renal tubules, is the major transporter responsible for tubular filtered glucose reabsorption. Dapagliflozin is a SGLT2 inhibitor. By inhibiting SGLT2, it reduces the reabsorption of filtered glucose and lowers the renal threshold of glucose, thereby increasing urinary glucose excretion. Clinically, it is mainly used to improve blood sugar control in adult patients with type 2 diabetes. [0003] The study of drug pharmacokinetics and bioequivalence is evaluated by measuring the pharmacokinetic parameters of drugs, and the detection and analysis of drugs is very important. Dapagliflozin biological samples have complex components, large matrix ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679
Inventor 徐凤华王荣
Owner SUZHOU SCI&TECH TOWN HOSPITAL
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