A method for the separation and determination of empagliflozin and its optical isomers

A technology of optical isomers and test solution, applied in material separation, measuring devices, scientific instruments, etc., to achieve the effect of strong specificity, good durability, and good specificity

Active Publication Date: 2021-05-11
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, there is no report on the determination method of empagliflozin and its optical isomers. In order to ensure the controllable quality of empagliflozin and ensure its effectiveness and safety, there is an urgent need for an effective detection method that can separate Determination of Empagliflozin and its optical isomers

Method used

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  • A method for the separation and determination of empagliflozin and its optical isomers
  • A method for the separation and determination of empagliflozin and its optical isomers
  • A method for the separation and determination of empagliflozin and its optical isomers

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Instruments and Conditions

[0037] High performance liquid chromatography: Agilent 1260;

[0038] Chromatographic column: amylose derivative chiral column (CHIRALCEL IF, 4.6×250mm, 5µm);

[0039] Mobile phase: methanol-ethanol-n-hexane (16:11:73)

[0040] Injection volume: 10μl;

[0041] Flow rate: 1ml / min;

[0042] Column temperature: 30°C;

[0043] Detection wavelength: 224nm.

[0044] Experimental procedure

[0045] Take about 15 mg of Empagliflozin raw material, accurately weigh it, put it in a 10ml volumetric flask, add methanol to dissolve and dilute to the mark, shake well, and use it as the test solution. Get solvent (mobile phase) and need testing solution, carry out HPLC analysis under above-mentioned chromatographic conditions, record chromatogram, see figure 1 , figure 2 . The results showed that the solvent did not interfere with the detection of empagliflozin, and the specificity of the method was good.

Embodiment 2

[0047] Instruments and Conditions

[0048] High performance liquid chromatography: Agilent 1260;

[0049] Chromatographic column: amylose derivative chiral column (CHIRALCEL IF, 4.6×250mm, 5µm);

[0050] Mobile phase: methanol-ethanol-n-hexane (16:11:73)

[0051] Injection volume: 10μl;

[0052] Flow rate: 1ml / min;

[0053] Column temperature: 30°C;

[0054] Detection wavelength: 224nm.

[0055] Experimental procedure

[0056] Take an appropriate amount of empagliflozin optical isomers A and B, accurately weigh them, put them in a 10ml volumetric flask, add methanol to dissolve and dilute to the mark, shake well, and then quantitatively dilute to make each 1ml contain 7.5% of each of A and B. μg / ml solution, as the reference solution. Get reference substance solution, carry out HPLC analysis under above-mentioned chromatographic conditions, record chromatogram, see image 3 . The results show that empagliflozin optical isomers A and B can be well separated, the peak h...

Embodiment 3

[0058] Instruments and Conditions

[0059] High performance liquid chromatography: Agilent 1260;

[0060] Chromatographic column: amylose derivative chiral column (CHIRALCEL IF, 4.6×250mm, 5µm);

[0061] Mobile phase: methanol-ethanol-n-hexane (16:11:73)

[0062] Injection volume: 10μl;

[0063] Flow rate: 1ml / min;

[0064] Column temperature: 30°C;

[0065] Detection wavelength: 224nm.

[0066] Experimental procedure

[0067] Take about 15 mg of empagliflozin raw material, weigh it accurately, put it in a 10ml volumetric flask, add methanol to dissolve, then add appropriate amount of empagliflozin optical isomers A and B, dilute to the mark with methanol, shake well, and prepare Make a solution containing 1.5 mg of empagliflozin per 1 ml and 7.5 μg / ml of optical isomers A and B each, as a mixed solution. Get mixed solution, carry out HPLC analysis under above-mentioned chromatographic condition, record chromatogram, see Figure 4 . The results showed that empagliflozin...

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Abstract

The invention discloses a method for separating and measuring empagliflozin and its optical isomers. The method adopts high-performance liquid chromatography, uses a chiral column of amylose or cellulose derivatives as a chromatographic column, and separates and measures empagliflozin. Ggliflozin and its optical isomers can be used for quality control of empagliflozin and pharmaceutical compositions containing empagliflozin.

Description

technical field [0001] The invention belongs to the field of drug analysis methods, and in particular relates to a method for separating and measuring the hypoglycemic drug empagliflozin and its optical isomers by using high performance liquid chromatography. Background technique [0002] Empagliflozin is a selective sodium-glucose cotransporter (SGLT) inhibitor for the treatment of type 2 diabetes in adults. Empagliflozin restricts the reabsorption of most glucose in the body through the selective inhibitory effect on sodium-glucose co-transporter, and promotes a large amount of glucose to be excreted from the urine to achieve the purpose of controlling blood sugar levels. [0003] The chemical structural formula of Empagliflozin is as follows: [0004] [0005] Its chemical name is: (1S)-1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furyl]oxy]phenyl] Methyl]phenyl]-D-glucitol. [0006] There are 6 chiral centers in the structure of Empagliflozin, and correspond...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 陈皓周冰刘泽荣张道林林蒙翟春密
Owner CHONGQING PHARMA RES INST
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