Method for measuring Jardiance and related substances of Jardiance through separation

A technology related to substances and organic phases, applied in the direction of material separation, measuring devices, and analyzing materials, etc., to achieve the effects of high theoretical plate number, small baseline noise, 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

[0007] 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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  • Method for measuring Jardiance and related substances of Jardiance through separation
  • Method for measuring Jardiance and related substances of Jardiance through separation
  • Method for measuring Jardiance and related substances of Jardiance through separation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Instruments and Conditions

[0049] High performance liquid chromatography: Agilent 1260;

[0050] Chromatographic column: a chromatographic column filled with octylsilane bonded silica gel (ZORBAX Rx-C8, 4.6×250mm, 5µm);

[0051] 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);

[0052] time (min) Mobile phase A(%) Mobile phase B(%) 0 55 45 19.5 55 45 50 25 75 60 25 75 60.5 55 45 70 55 45

[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 tes...

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] time (min) Mobile phase A(%) Mobile phase B(%) 0 55 45 19.5 55 45 50 25 75 60 25 75 60.5 55 45 70 55 45

[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...

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] time (min) Mobile phase A(%) Mobile phase B(%) 0 55 45 19.5 55 45 50 25 75 60 25 75 60.5 55 45 70 55 45

[0077] Injection volume: 20μl;

[0078] Fl...

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Abstract

The invention discloses a method for measuring Jardiance and related substances of Jardiance through separation. According to the method, gradient elution are performed by adopting high performance liquid chromatography, utilizing octyl silane bonded silica gel filler or phenyl silane bonded silica gel filler as a chromatographic column and adopting a moving phase formed by a phosphoric acid solution, methyl alcohol and acetonitrile. With the adoption of the method, Jardiance and related substances of Jardiance can be separated very well, the detection is good in reproducibility, high in sensitivity and specificity and simple to operate, and control for quality and medication safety of Jardiance is facilitated.

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. [0006] Empagliflozin is a fully synthetic chemical drug, and the by-products or residual inte...

Claims

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Application Information

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Patent Type & Authority Applications(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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