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Method for separately determining dutasteride starting material SM2 and related impurities thereof through HPLC (High Performance Liquid Chromatography) method

A technology for dutasteride and impurities, which is applied in the field of separation and determination of dutasteride starting material SM2 and its related impurities by HPLC, can solve the problems of separation and determination that have not been reported in literature, and achieve high accuracy and specificity Good, highly specific effect

Active Publication Date: 2018-05-18
CHONGQING HUAPONT PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0013] The current key starting material SM for dutasteride 2 The separation and determination of related impurities have not been reported in the literature

Method used

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  • Method for separately determining dutasteride starting material SM2 and related impurities thereof through HPLC (High Performance Liquid Chromatography) method
  • Method for separately determining dutasteride starting material SM2 and related impurities thereof through HPLC (High Performance Liquid Chromatography) method
  • Method for separately determining dutasteride starting material SM2 and related impurities thereof through HPLC (High Performance Liquid Chromatography) method

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Embodiment 1

[0065] 1. Chromatographic conditions

[0066] Chromatographic column: silica gel column ZORBAX SIL, 250mm×4.6mm, 5μm

[0067] Detection wavelength: 254nm Flow rate: 1.0ml / min

[0068] Injection volume: 20μl Column temperature: 30℃

[0069] Mobile phase: n-hexane:isopropanol=95:5

[0070] Diluent: mobile phase

[0071] 2. Experimental steps

[0072] Impurity SM 2a Positioning solution: weigh the impurity SM 2a 10.12mg, put it in a 50ml measuring bottle, add diluent to dissolve and dilute to the mark, shake well, that is.

[0073] Impurity SM 2b Positioning solution: weigh the impurity SM 2b 51.74mg, put it in a 25ml measuring bottle, add diluent to dissolve and dilute to the mark, shake well, that is.

[0074] Impurity SM 2c Positioning solution: weigh the impurity SM 2c 24.28mg, put it in a 25ml measuring bottle, add diluent to dissolve and dilute to the mark, shake well, that is.

[0075] Impurity SM 2d Positioning solution: weigh the impurity SM 2d 25.89mg, pu...

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Abstract

The invention belongs to the field of analytical chemistry and in particular relates to a method for separately determining a dutasteride starting material SM2 and related impurities thereof through an HPLC (High Performance Liquid Chromatography) method. A chromatographic column adopted by the method takes octadecyl silane bonded silica gel as filling, and a mixed solution of n-hexane and isopropyl alcohol is used as a mobile phase for eluting and enters a detector to be detected; the related impurities comprise one or more of SM2a, SM2b, SM2c, SM2d, SM2e and SM2f. The method provided by theinvention can realize effective separation of the impurity SM2a, the impurity SM2b, the impurity SM2c, the impurity SM2d, the impurity SM2e and the impurity SM2f in the SM2, has good specificity and free from interference by a blank and other impurities; the separation degree between each two impurity peaks is greater than 1.5 and meets related material requirements. The method has extremely important meanings on realization of quality control of the dutasteride starting material SM2 and dutasteride.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to an HPLC method for the separation and determination of dutasteride starting material SM 2 and its related impurities. Background technique [0002] Dutasteride is a white crystalline solid chemical with the molecular formula [0003] C 27 h 30 f 6 N 2 o 2 , is a new dual inhibitor of 5α reductase, it can inhibit both 5α reductase 1 and 5α reductase 2, clinically used for prostate enlargement, male pattern alopecia, seborrheic alopecia, hereditary Hair loss, mainly used in the treatment of benign prostatic hyperplasia in men. A large number of clinical trials have shown that dutasteride can significantly reduce the level of dihydrotestosterone in human blood and prostate in the long-term compared with finasteride, and can continuously and effectively reduce the volume of the prostate. Its structural formula is as follows: [0004] [0005] The original manufacturer ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/047
Inventor 杨婧夏爽周春燕唐朝军
Owner CHONGQING HUAPONT PHARMA
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