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Separation and determination method of empagliflozin and optical isomers thereof

An optical isomer and chiral column technology is applied in the field of separation and determination of the hypoglycemic drug empagliflozin and its optical isomers by high performance liquid chromatography, and achieves the effects of strong specificity, high sensitivity and good specificity

Active Publication Date: 2017-05-24
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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  • Separation and determination method of empagliflozin and optical isomers thereof
  • Separation and determination method of empagliflozin and optical isomers thereof
  • Separation and determination method of empagliflozin and optical isomers thereof

Examples

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 separation and determination method of empagliflozin and optical isomers thereof. The method separates and determines the empagliflozin and the optical isomers thereof by adopting a high performance liquid chromatography and taking amylose or cellulose derivative chiral columns as chromatographic columns. The method can be used for controlling the quality of the empagliflozin and pharmaceutical compositions containing the 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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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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