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
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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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