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RT-HPLC detection method of piperazine ferulate related substances

A RT-HPLC, piperazine ferulate technology, applied in the field of drug analysis, can solve problems such as the inability to measure related substances, the inability to effectively measure 8 specific impurities, the research on impurities and degradation impurities, etc.

Active Publication Date: 2021-07-06
成都亨达药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method is only a content determination method and cannot be used to determine related substances
[0014] The reported analysis method of piperazine ferulate failed to fully study the impurities and degradation impurities produced in the synthesis process of piperazine ferulate, and could not effectively determine the above-mentioned 8 substances including the cis isomer. specific impurities

Method used

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  • RT-HPLC detection method of piperazine ferulate related substances
  • RT-HPLC detection method of piperazine ferulate related substances
  • RT-HPLC detection method of piperazine ferulate related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] (1) Instrument and chromatographic conditions

[0055] High performance liquid chromatography: U3000 high performance liquid chromatography system and workstation;

[0056] Chromatographic column: Thermo Acclaim (4.6mm×250mm, 5μm) octadecylsilane bonded silica gel column;

[0057] Configure 0.01M sodium acetate solution-methanol (80:20) as phase A, use 0.01M sodium acetate solution-methanol (20:80) as phase B, and the ratio of phase A in the mobile phase is 0, 40, 60, 70, At time points of 71 and 80 minutes, the volume ratio of phase A is 90%, 90%, 20%, 20%, 90%, and 90% for gradient elution, the flow rate is 1.0ml / min; the column temperature is 35°C, and the detection wavelength is 287nm;

[0058] (2) Experimental steps

[0059] Take respectively appropriate amount of piperazine ferulic acid reference substance, impurity A, impurity B, impurity D, impurity E, impurity F, impurity I and impurity J reference substance, with solvent [0.01M acetate solution-methanol (60:...

Embodiment 2

[0064] (1) Instrument and chromatographic conditions

[0065] High performance liquid chromatography: U3000 high performance liquid chromatography system and workstation;

[0066] Chromatographic column: Octadecylsilane bonded silica gel column of Thermo Acclaim (4.6mm×250mm, 5μm)

[0067] Configure water-methanol-acetic acid (80:20:0.1) as phase A, use water-methanol-acetic acid (20:80:0.1) as phase B, and the ratio of phase A in the mobile phase is 0, 15, 25, 26, At the time point of 35 minutes, the volume ratio of phase A was 50%, 40%, 40%, 50%, and 50% for gradient elution, the flow rate was 1.0ml / min; the column temperature was 35°C, and the detection wavelength was 287nm;

[0068] (2) Experimental steps

[0069] Take respectively appropriate amounts of piperazine ferulic acid reference substance, impurity A, impurity B, impurity D, impurity E, impurity F, impurity I and impurity J reference substance, with solvent [water-methanol-acetic acid (60:40:0.1) ] Prepare a sy...

Embodiment 3

[0074] (1) Instrument and chromatographic conditions

[0075] High performance liquid chromatography: U3000 high performance liquid chromatography system and workstation;

[0076] Chromatographic column: Octadecylsilane bonded silica gel column of Thermo Acclaim (4.6mm×250mm, 5μm)

[0077] Configure water-methanol-acetic acid (80:20:0.1) as phase A, water-methanol-acetic acid (20:80:0.1) as phase B, and the ratio of phase A in the mobile phase is 0, 40, 60, 70, At time points of 71 and 80 minutes, the volume ratio of phase A is 90%, 90%, 40%, 40%, 90%, and 90% for gradient elution, the flow rate is 1.0ml / min; the column temperature is 35°C, and the detection wavelength is 287nm;

[0078] (2) Experimental steps

[0079] Take respectively appropriate amounts of piperazine ferulic acid reference substance, impurity A, impurity B, impurity D, impurity E, impurity F, impurity I and impurity J reference substance, with solvent [water-methanol-acetic acid (60:40:0.1) ] Prepare a s...

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Abstract

The invention relates to the technical field of pharmaceutical analysis, and discloses an RT-HPLC detection method of piperazine ferulate related substances, which comprises the following steps: preparing an analysis solution; using a reversed-phase chromatographic column, using acid or acid and carboxylate aqueous solution-organic phase mixed liquid as a mobile phase, and adopting a gradient elution method; and measuring the prepared analysis solution on a machine. The analysis method provided by the invention can effectively and accurately determine various related impurities in piperazine ferulate, thereby ensuring the controllable quality of the product.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a reverse high performance liquid chromatography detection method for related substances of piperazine ferulate. Background technique [0002] The so-called "related substances" in drug analysis refer to the substances such as starting materials, reagents, intermediates, by-products and isomers brought in during the production of raw materials, and may also be Special impurities such as degradation products, polymers or crystal transformations produced during storage and transportation. The type of related substances is closely related to the synthesis route and preparation process of the drug. Any change in any factor in the process of drug synthesis and preparation may lead to different types of related substances. Therefore, the detection and control process of related substances is relatively complicated. The detection of related substances is an important indicator fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74G01N30/60
CPCG01N30/06G01N30/74G01N30/60Y02A50/30
Inventor 何亚洲王枫朱丽君魏伟业吴小涛赵卿霍立茹李战
Owner 成都亨达药业有限公司
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