Methods for analysis and resolution of preparations of dianhydrogalactitol and derivatives or analogs thereof

A technology of anhydrogalactitol and analysis method, which is applied in the analysis field of preparations and can solve the problems of high incidence

Active Publication Date: 2018-10-23
DEMA PHARM (BC) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Such patients may experience a higher incidence of undesirable side effects due to their sensitivity to pollutants

Method used

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  • Methods for analysis and resolution of preparations of dianhydrogalactitol and derivatives or analogs thereof
  • Methods for analysis and resolution of preparations of dianhydrogalactitol and derivatives or analogs thereof
  • Methods for analysis and resolution of preparations of dianhydrogalactitol and derivatives or analogs thereof

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[0061] Reverse phase HPLC analysis of dianhydrogalactitol preparation using acetonitrile and water gradient

[0062] In general, this test procedure is used to determine one or more correlations in DAG drugs and drug formulations by high performance liquid chromatography (HPLC) (HPLC-ELSD) with ELSD detection substance. A reverse phase chromatography column (Waters Amide, 3.5 μm, 4.6×250 mm) with 100% acetonitrile (ACN) as mobile phase A and 100% water as mobile phase B was used. The flow rate is 0.8 mg / mL. The DAG peak was detected with a retention time of about 5.20 minutes. DAG samples were prepared at a target concentration of 8 mg / mL.

[0063] Reagents and reference standards

[0064] Reagents and reference standards include: (1) HPLC grade pure water (H 2 O) or equivalent; (2) HPLC grade acetonitrile (ACN) or equivalent; and (3) galactitol reference standard.

[0065] Instruments and devices

[0066] Instruments and devices include: (1) Shimadzu LC20A HPLC system or equiva...

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Abstract

An improved analytical method for analysis of dianhydrogalactitol preparations provides a method for determining the purity of dianhydrogalactitol and detecting impurities in preparations of dianhydrogalactitol, as well as identifying any such impurities. The method employs high performance liquid chromatography (HPLC), in particular, HPLC employing a reverse phase amide column with ELSD detection; the HPLC can be followed by tandem mass spectroscopy. The method can further comprise the step of performing preparative HPLC collection of at least one specific substance peak present in a preparation of dianhydrogalactitol.

Description

[0001] Cross references to related applications [0002] This application claims to be submitted by Q.Xu on November 25, 2015, entitled "Methods for Analysis and Resolution of Preparations of Dianhydrogalactitol and Derivatives or Analogs Thereof)" US Provisional Patent No. 62 / 260,019, the content of which is incorporated herein by reference in its entirety. Technical field [0003] The present invention relates to an improved analysis method for preparations of dianhydrogalactitol and its derivatives or analogs, and particularly relates to high performance liquid chromatography (HPLC). Background technique [0004] Dianhydrogalactitol (1,2:5,6 Dianhydrogalactitol or DAG) is one of a variety of hexitol or hexitol derivatives, with significant pharmacological activity, including chemotherapeutic activity. In particular, dianhydrogalactitol has been proposed for chemotherapy, as in US Patent No. 7,157,079 to Nielsen et al., which is incorporated herein by reference. [0005] Dianhydro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D303/14C07D301/02G01N30/22
CPCC07D303/14B01D15/305G01N30/34G01N30/30G01N30/88G01N2030/324G01N2030/8872G01N30/22G01N30/7233G01N30/74G01N2030/027
Inventor 徐强
Owner DEMA PHARM (BC) CO LTD
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