A method for determining related substances in trexagliptin tablets

A technology related to substances and tablets, applied in the field of analytical chemistry, can solve the problems that it is impossible to completely control the quality of this product, and achieve the effect of solving the problem of separation and measurement and controlling the quality

Active Publication Date: 2016-11-09
ZHONGSHAN WANHAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

All these aspects indicate that the previously disclosed analytical methods cannot completely control the quality of this product

Method used

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  • A method for determining related substances in trexagliptin tablets
  • A method for determining related substances in trexagliptin tablets
  • A method for determining related substances in trexagliptin tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Instruments and experimental conditions:

[0038] High performance liquid chromatography: Shimadzu LC-16,

[0039] Chromatographic column: Xselect C18 (Waters, 150×4.6mm, 3.5um),

[0040] Mobile phase A is phosphoric acid aqueous solution, pH=2.0, mobile phase B is acetonitrile; linear gradient elution according to Table 2.

[0041]

[0042]

[0043] The flow rate is 1.2mL / min,

[0044] Column temperature 35°C,

[0045] Detection wavelength 224nm,

[0046] The injection volume was 10 μl.

[0047] Experimental steps:

[0048] Take the blank solution and the impurity reference substance solution respectively, carry out high-performance liquid chromatography analysis according to the above experimental conditions, and record the chromatograms. The results are shown in the attached figure 1 And attached figure 2 , API in the figure represents Trexagliptin.

[0049] figure 2 In the middle is the chromatogram corresponding to trexagliptin and each known impuri...

Embodiment 2

[0051] Instruments and experimental conditions:

[0052] High performance liquid chromatography: Shimadzu LC-16,

[0053] Chromatographic column: Xselect C18 (Waters, 150×4.6mm, 3.5um),

[0054] Mobile phase A is phosphoric acid aqueous solution, pH 2.0, mobile phase B is acetonitrile; linear gradient elution according to Table 3.

[0055]

[0056]

[0057] The flow rate is 1.2mL / min,

[0058] Column temperature 35°C,

[0059] Detection wavelength 224nm,

[0060] The injection volume was 10 μl.

[0061] Experimental steps:

[0062] Get Trexagliptin tablet sample powder 49.42mg (containing Trexagliptin 24.99mg), put in the 50ml measuring bottle, be 10% acetonitrile dissolving sample with volume percentage, be mixed with every 1mL containing Trexagliptin 0.988mg sample solution.

[0063] Get impurity reference substance solution and trexagliptin tablet sample solution respectively, carry out high performance liquid chromatography analysis by above-mentioned experimenta...

Embodiment 3

[0067] Instruments and experimental conditions:

[0068] High performance liquid chromatography: Shimadzu LC-16,

[0069] Chromatographic column: Cortecs C18 (Waters, 150×4.6mm, 2.7um),

[0070] Mobile phase A is phosphoric acid aqueous solution, pH=2.0, mobile phase B is acetonitrile solution; linear gradient elution according to Table 5.

[0071]

[0072]

[0073] The flow rate is 1.2mL / min

[0074] Column temperature 35°C

[0075] Detection wavelength 224nm

[0076] The injection volume was 10 μl.

[0077] Experimental steps:

[0078] Take trexagliptin tablet sample powder 50.68mg (containing trexagliptin 25.02mg), put in a 50ml measuring bottle, dissolve the sample with 10% acetonitrile, and be prepared into a sample solution containing trexagliptin 1.01mg per 1mL.

[0079] Take impurity reference substance solution and trexagliptin tablet sample solution respectively, carry out high performance liquid chromatography analysis according to above-mentioned experim...

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Abstract

The invention provides a method for determining related substances in Trelagliptin tablets, and relates to the field of analytical chemistry. The method comprises the steps that a high-performance liquid chromatography method is adopted, a sample solution is injected into a high-performance liquid chromatographic instrument, determination of the related substances in the Trelagliptin tablets is completed, and the chromatographic conditions are that a chromatographic column takes silica gel of which the surface is provided with electric hybrid particles as a filler, a mobile phase A is an acidic aqueous solution, a mobile phase B is an organic solvent, the sum of the volume percent of the mobile phase A and the volume percent of the mobile phase B maintains 100% all the time, and linear gradient elution is conducted. According to the method for determining the related substances in the Trelagliptin tablets, an Xselect C18 chromatographic column is adopted, optimization is conducted on the mobile phase gradient elution program, and the related substances in the Trelagliptin tablets can be effectively separated. The separation determination problem of the related substances in the Trelagliptin tablets is solved, and therefore it is guaranteed that the quality of the Trelagliptin tablets is controllable.

Description

technical field [0001] The invention relates to the field of analytical chemistry, in particular to a method for determining related substances in trexagliptin tablets. Background technique [0002] Among the antidiabetic drugs, the research of orally administered small molecule DPP-IV inhibitors is the most active. DPP-IV is an enzyme in the body that triggers the inactivation of incretins, glucone-like peptide-1 and glucose-dependent insulinotropic polypeptide, two incretins that play an important role in blood glucose regulation . Inhibition of DPP-IV can increase blood glucose level-dependent insulin secretion, thereby controlling blood glucose levels. [0003] DPP-IV inhibitor drugs are named "gliptins". There are 17 such drugs. Among them, trexagliptin was developed by Takeda Pharmaceutical and was first approved for marketing in Japan in 2014. It is an ultra-long-acting The DPP-IV inhibitor only needs to be taken orally once a week, which can produce continuous DPP...

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 杜志博王鹤然陈嘉智邵诗雅徐小林彭韪
Owner ZHONGSHAN WANHAN PHARM CO LTD
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