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A kind of method for separation and determination of empagliflozin and related substances

A technology related to substances and organic phases, applied in material separation, measuring devices, analyzing materials, etc., to achieve the effect of strong practicability, good reproducibility and strong 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

[0006] At present, there is no report on the related substance determination method of empagliflozin and its composition. In order to ensure the controllable quality of empagliflozin raw material drug and its pharmaceutical composition, to ensure its effectiveness and safety, a method is urgently needed. An effective detection method, which can effectively separate and measure empagliflozin and its related substances

Method used

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  • A kind of method for separation and determination of empagliflozin and related substances
  • A kind of method for separation and determination of empagliflozin and related substances
  • A kind of method for separation and determination of empagliflozin and related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Instruments and Conditions

[0048] High performance liquid chromatography: Agilent 1260;

[0049] Chromatographic column: a chromatographic column filled with octylsilane bonded silica gel (ZORBAX Rx-C8, 4.6×250mm, 5µm);

[0050] Mobile phase A: phosphoric acid solution, take purified water, adjust the pH value to 3.5 with phosphoric acid, mobile phase B: methanol-acetonitrile (50:50V / V);

[0051] According to the gradient elution Table 1 elution (after 60min is the stage of flushing the column to balance the system).

[0052]

[0053] Injection volume: 20μl;

[0054] Flow rate: 1ml / min;

[0055] Column temperature: 25°C;

[0056] Detection wavelength: 224nm.

[0057] Experimental procedure

[0058] Take about 20 mg of Empagliflozin raw material, accurately weigh it, put it in a 25ml volumetric flask, add mobile phase 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 ou...

Embodiment 2

[0060] Instruments and Conditions

[0061] High performance liquid chromatography: Agilent 1260;

[0062] Chromatographic column: a chromatographic column filled with octylsilane bonded silica gel (ZORBAX Rx-C8, 4.6×250mm, 5µm);

[0063] Mobile phase A: phosphoric acid solution, take purified water, adjust the pH value to 3.5 with phosphoric acid, mobile phase B: methanol-acetonitrile (50:50);

[0064] Elute according to the gradient elution table (see Table 2) (after 60 min, it is the stage of flushing the column to balance the system).

[0065]

[0066] Injection volume: 20μl;

[0067] Flow rate: 1ml / min;

[0068] Column temperature: 25°C.

[0069] Experimental procedure

[0070] Take about 20mg of the crude drug of Empagliflozin, accurately weigh it, put it in a 25ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution. Get need testing solution, carry out HPLC analysis under above-mentioned chromatograp...

Embodiment 3

[0072] Instruments and Conditions

[0073] High performance liquid chromatography: Agilent 1260;

[0074] Chromatographic column: a chromatographic column filled with octylsilane bonded silica gel (ZORBAX Rx-C8, 4.6×250mm, 5µm);

[0075] One set of mobile phase A: phosphoric acid solution, take purified water, use phosphoric acid to adjust the pH value to 2.0, another set of mobile phase A: phosphoric acid solution, take purified water, use phosphoric acid to adjust the pH value to 6.0, mobile phase B: methanol-acetonitrile (50:50); the two groups of mobile phase A were combined with mobile phase B respectively according to the gradient elution table (see Table 3) and eluted once each (after 60 minutes, it was the stage of flushing the column to balance the system).

[0076]

[0077] Injection volume: 20μl;

[0078] Flow rate: 1ml / min;

[0079] Column temperature: 25°C;

[0080] Wavelength: 224nm.

[0081] Experimental procedure

[0082] Take about 20 mg of the crude ...

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Abstract

The invention discloses a method for separating and measuring empagliflozin and its related substances. The method adopts high performance liquid chromatography, uses octylsilane bonded silica gel packing or phenylsilane bonded silica gel packing as a chromatographic column, and uses Phosphoric acid solution, methanol and acetonitrile constitute the mobile phase for gradient elution. The method can well separate empagliflozin and its related substances, has good detection reproducibility, high sensitivity, strong specificity, and simple operation, and is helpful for controlling the quality and drug safety of 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 related substances 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 by selectively inhibiting the 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. Empagliflozin is a fully synthetic chemical drug, and the by-products or residual intermediates...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 陈皓李雪逃刘泽荣张道林冯浩周冰汪维维
Owner CHONGQING PHARMA RES INST
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