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Detection method and application of dehydroepiandrosterone-17-hydrazone and its related substances

A dehydroepiandrosterone and detection method technology, which is applied in the detection field of dehydroepiandrosterone-17-hydrazone and its related substances, can solve the problems affecting the quality of raw materials and the production quality of raw materials, and achieve specificity And the effect of good durability and high sensitivity

Active Publication Date: 2022-05-10
SHANXI ZHENDONG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] DHEA-17-hydrazone is an important part of the synthesis of abiraterone acetate. If DHEA-17-hydrazone contains impurities, when using it for the production of raw materials, the impurities contained therein or the transformation products of impurities may Then enter the subsequent reaction, affect the production quality of raw materials, and may affect the quality of raw materials

Method used

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  • Detection method and application of dehydroepiandrosterone-17-hydrazone and its related substances
  • Detection method and application of dehydroepiandrosterone-17-hydrazone and its related substances
  • Detection method and application of dehydroepiandrosterone-17-hydrazone and its related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] This embodiment provides a detection method for dehydroepiandrosterone-17-hydrazone and related substances, including the following steps:

[0058] (1) The test solution (containing related substances I and II)

[0059] Preparation of the test solution

[0060] Precisely measure 0.5mL of the related substance Ⅰ solution and 0.5mL of the related substance Ⅱ solution, and place them in a 50mL volumetric flask. Accurately weigh about 25mg of the dehydroepiandrosterone-17-hydrazone sample and place it in the above volumetric flask, add 10mL of acetonitrile to dissolve, Then use the diluent to adjust the volume to the mark, and prepare a solution containing 10 μg of related substances I and II and 0.5 mg of dehydroepiandrosterone-17-hydrazone per 1 mL;

[0061] Among them, the preparation method of the related substance Ⅰ solution: Weigh about 10 mg of the related substance Ⅰ sample into a 10 mL volumetric flask, add 5 mL of acetonitrile to dissolve, then dilute to the mark...

Embodiment 2

[0078] This example refers to the detection method of Example 1, the only difference being: in the high performance liquid chromatography detection condition of step (2), the column temperature is 25°C.

Embodiment 3

[0080] This example refers to the detection method of Example 1, the only difference being: in the high performance liquid chromatography detection condition of step (2), the column temperature is 40°C.

[0081] See Table 3 for the degree of separation between dehydroepiandrosterone-17-hydrazone and related substance I and related substance II in Examples 1-3.

[0082] Table 3 Separation data between each component

[0083]

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Abstract

The invention relates to the technical field of chemical drug analysis methods, in particular to a detection method and application of dehydroepiandrosterone-17-hydrazone and related substances. The detection method of dehydroepiandrosterone-17-hydrazone and its related substances comprises the steps of: adopting high performance liquid chromatography to detect the solution of the test product; the detection conditions of the chromatography include: the detection wavelength is 202~220nm; : pH is 6.3~6.7 aqueous solution containing salt; said salt includes ammonium salt of phosphoric acid, potassium salt of phosphoric acid, sodium salt of phosphoric acid, ammonium salt of carbonic acid, potassium salt of carbonic acid, sodium salt of carbonic acid, ammonium salt of acetic acid , any one or more of the potassium salt of acetic acid and the sodium salt of acetic acid; mobile phase B: acetonitrile; using the mobile phase A and the mobile phase B to carry out a certain gradient elution. The invention can efficiently separate dehydroepiandrosterone-17-hydrazone and related substances at one time, has high sensitivity, and has good specificity and durability.

Description

technical field [0001] The invention relates to the technical field of chemical drug analysis methods, in particular to a detection method and application of dehydroepiandrosterone-17-hydrazone and related substances. Background technique [0002] DHEA-17-hydrazone, the compound 5-androstene-3β-ol-17-hydrazone, is a key intermediate in the synthesis of the drug Abiraterone Acetate, and its structure is as follows: [0003] [0004] DHEA-17-hydrazone is an important part of the synthesis of abiraterone acetate. If DHEA-17-hydrazone contains impurities, when it is used for the production of raw materials, the impurities contained therein or the transformation products of impurities may Then it enters the follow-up reaction, which affects the production quality of the raw material drug, and may affect the quality of the raw material drug. Therefore, it is of great significance to have an accurate understanding of the impurities of dehydroepiandrosterone-17-hydrazone, and to...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/74G01N2030/047
Inventor 张辉游蓉丽李英李建伟解晓冬
Owner SHANXI ZHENDONG PHARMA