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High performance liquid chromatography detection method of abiraterone acetate related substances

A technology of abiraterone acetate and high-performance liquid chromatography, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of not being able to effectively guarantee the safety of abiraterone acetate and the small number of impurities detected, and achieve good separation , improve the purity, the effect of simple method

Active Publication Date: 2020-08-07
GANSU LANYAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the prior art, the detection of the impurity content of abiraterone acetate has the problem that the number of detected impurities is not many, and the safety of abiraterone acetate cannot be effectively guaranteed

Method used

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  • High performance liquid chromatography detection method of abiraterone acetate related substances
  • High performance liquid chromatography detection method of abiraterone acetate related substances
  • High performance liquid chromatography detection method of abiraterone acetate related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The present embodiment provides the degree of separation test of the inventive method, specifically:

[0045] Liquid chromatograph: LC-2030; Chromatographic conditions: use octadecylsilane bonded silica gel as filler (Prontosil120-3-c18-ace-EPS, 150×3.0mm, 3.0μm), with 0.01mol / L Ammonium acetate solution is mobile phase A, acetonitrile is mobile phase B, and ethanol is mobile phase C. Carry out gradient elution according to the table below. The mobile phase flow rate is 0.8ml / min, the detection wavelength is 254nm, and the column temperature is 20°C.

[0046]

[0047]

[0048] Preparation of the test solution: Accurately weigh abiraterone acetate, put it in a 10ml measuring bottle, add acetonitrile to dissolve and dilute to the mark, and make a test solution containing about 1mg per 1ml;

[0049] Preparation of Abiraterone Acetate Control Solution: Accurately measure an appropriate amount of the test solution, dilute with acetonitrile to make a solution containing...

Embodiment 2

[0056] This embodiment provides a sensitivity test of the method of the present invention, and the chromatographic conditions are the same as in Example 1.

[0057] Sensitivity solution: Accurately measure 3 μl of the abiraterone acetate control solution in Example 1, put it in a 50ml measuring bottle, dilute it to the mark with acetonitrile, and use it as the sensitivity solution.

[0058] Precisely measure 10 μL of the sensitivity solution, inject it into the chromatograph, and record the chromatogram. figure 2 shown.

[0059] Sensitivity tests showed that the signal-to-noise ratio of the main peak was not lower than 10:1, indicating that the method had high sensitivity and could effectively and quantitatively detect the impurities in abiraterone acetate, thereby ensuring the safety of medication.

Embodiment 3

[0061]The present embodiment adopts the method for the determination of related substances of abiraterone acetate by high performance liquid chromatography of the present invention, specifically:

[0062] Liquid chromatograph and chromatographic column are with embodiment 1.

[0063] With 0.005mol / L ammonium acetate solution as mobile phase A, acetonitrile as mobile phase B, and ethanol as mobile phase C, carry out gradient elution according to the following table, the mobile phase flow rate is 0.3ml / min, the detection wavelength is 254nm, and the column temperature is 25°C.

[0064] time (minutes) Mobile phase A(%) Mobile phase B(%) Mobile phase C(%) 0 45 25 30 35 12 58 30 50 3 20 77 60 3 20 77 62 45 25 30 70 45 25 30

[0065] All the other operating steps and conditions are the same as in Example 1.

[0066] The results show that the solvent peak has no interference to abiraterone acetate and its related substanc...

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Abstract

The invention discloses a high performance liquid chromatography detection method of abiraterone acetate related substances, which can detect impurities from the initial synthesis step to the final finished product process, thereby effectively ensuring the safety and effectiveness of drugs. Chromatographic conditions of the method are as follows: octadecylsilane chemically bonded silica is used asa filler, a buffer salt solution is used as a mobile phase A, acetonitrile is used as a mobile phase B, and ethanol is used as a mobile phase C for gradient elution. The method is simple, easy to operate, high in specificity and high in sensitivity, the content of multiple related substances can be measured at the same time, and therefore the product quality of abiraterone acetate is effectivelyguaranteed, and medication safety is guaranteed.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a high performance liquid chromatography detection method for related substances of abiraterone acetate. Background technique [0002] Abiraterone acetate, its chemical name is 17-(3-pyridine)androst-5,16-diene-(3β)-acetate, its molecular formula is C 26 h 33 NO 2 , the molecular weight is 391.25, and its structural formula is [0003] [0004] As an androgen synthesis inhibitor, abiraterone acetate can inhibit the generation of CYP17 enzyme complex, thereby reducing the production of androgen in the body, and then can be used as a drug for treating advanced prostate cancer. Clinically, it can be used in combination with prednisone to treat metastatic prostate cancer patients who have received paclitaxel chemotherapy but have no effect. [0005] Abiraterone acetate will produce several impurities during the synthesis and storage process. Controlling the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34
CPCG01N30/02G01N30/06G01N30/34G01N2030/047Y02A50/30
Inventor 王志锋包正学雷文贵安玉洁苏海燕
Owner GANSU LANYAO PHARMA CO LTD
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