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Method for detecting and analyzing arranon

An analytical method and mobile phase technology, applied in the field of medicine, can solve the problems of patents or public literature reports of non-detection analytical methods, and achieve the effect of high sensitivity and good specificity

Inactive Publication Date: 2014-07-02
PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] After searching, there is currently no relevant patent or public literature report on the detection and analysis method for nelarabine

Method used

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  • Method for detecting and analyzing arranon
  • Method for detecting and analyzing arranon

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Measure according to Chinese Pharmacopoeia 2005 edition two appendix VD high performance liquid chromatography, with octadecyl bonded silica gel as filler, ODS pre-column,

[0076] The column temperature is 25°C, the detection wavelength is 210nm, the phosphoric acid solution is used as the mobile phase A, and the acetonitrile-phosphoric acid solution (1:2) is used as the mobile phase B, and the ratio of the mobile phase A is 92%, and the mobile phase B is 0-60 minutes. The proportion is 8%, 60-80 minutes, the proportion of mobile phase A is 70%, the proportion of mobile phase B is 30%, 80-90 minutes, the proportion of mobile phase A is 92%, the proportion of mobile phase B is 8% for gradient elution ;

[0077] Preparation of the test solution: Accurately weigh Nelarabine Injection (batch number: 080806), dilute with water, shake up, as the test solution;

[0078] Precisely draw the test solution and inject it into the liquid chromatograph, and record the chromatogram....

Embodiment 2

[0081] Measure according to Chinese Pharmacopoeia 2005 edition two appendix VD high performance liquid chromatography, with octadecyl bonded silica gel as filler, ODS pre-column,

[0082] The column temperature is 25°C, the detection wavelength is 247nm, the phosphoric acid solution is used as the mobile phase A, and the acetonitrile-phosphoric acid solution (1:1) is used as the mobile phase B, and the ratio of the mobile phase A is 92%, and the mobile phase B is 0-60 minutes. The proportion is 8%, 60-80 minutes, the proportion of mobile phase A is 70%, the proportion of mobile phase B is 30%, 80-90 minutes, the proportion of mobile phase A is 92%, the proportion of mobile phase B is 8% for gradient elution ;

[0083] Preparation of the test solution: Accurately weigh Nelarabine Injection (batch number: 080826), dilute with water, shake up, as the test solution;

[0084] Precisely draw the test solution and inject it into the liquid chromatograph, and record the chromatogram....

Embodiment 3

[0087] Measure according to Chinese Pharmacopoeia 2005 edition two appendix VD high performance liquid chromatography, with octadecyl bonded silica gel as filler, ODS pre-column,

[0088] The column temperature is 25°C, the detection wavelength is 210nm, the phosphoric acid solution is used as the mobile phase A, and the acetonitrile-phosphoric acid solution (2:1) is used as the mobile phase B, and the ratio of the mobile phase A is 92%, and the mobile phase B is 0-60 minutes. The proportion is 8%, 60-80 minutes, the proportion of mobile phase A is 70%, the proportion of mobile phase B is 30%, 80-90 minutes, the proportion of mobile phase A is 92%, the proportion of mobile phase B is 8% for gradient elution ;

[0089] Preparation of the test solution: Accurately weigh an appropriate amount of Nalarabine injection (batch number: 080905), dilute with water, shake well, and use it as the test solution;

[0090] Precisely draw the test solution and inject it into the liquid chrom...

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Abstract

The invention discloses a method for detecting and analyzing arranon. The method comprises a high-efficiency liquid chromatography of the arranon and arranon injection solution and is characterized by comprising the following steps of: detecting and analyzing related substances such as 2-amino-6-methoxy purine, arranon optical isomers, arranon geometric isomers and the like in the arranon and the arranon injection solution by using water, phosphoric acid and acetonitrile as mobile phases by a gradient elution method. By the method, the controllability of the related substances in the arranon and the arranon solution is ensured.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a detection and analysis method for nelarabine. Background technique [0002] Acute T-cell lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) are two diseases with very fast deterioration. The incidence rate is second only to ordinary acute lymphoblastic leukemia, accounting for the second incidence rate. Nelarabine is a water-soluble prodrug of 9-β-arabinofuranosylguanine (ara-G), which can produce ara-G in plasma, and ara-G has a selective cytotoxic effect on T cells. Therefore, nelarabine has a T-cell lymphoma is specific and has a good curative effect on T-ALL and T-LBL. On October 28, 2005, Nelarabine intravenous injection (250mg / 50ml) was approved by the FDA for the treatment of T-ALL and T-LBL that were ineffective or relapsed after at least two chemotherapy regimens. [0003] Related substances are closely related to the quality, safe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/36
Inventor 顾群米长江姜威孙学伟孙德杰
Owner PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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