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Key Documents

G1007268

HPLC Analysis of Itraconazole and Impurties on Chromolith® High Resolution RP-18e

application for HPLC

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technique(s)

HPLC: suitable

test parameters

sample preparation: 50 mg itraconazol dissolved in 50 mL solution (5 mL 30% hydrochloric acid in 1000 mL of methanol)
column: Chromolith High Resolution RP-18 endcapped, 100 x 4.6 m (1.52022.0001)
mobile phase: [A] acetonitrile; [B] methanol; [C] L Water + 3,4g TBAH-sulfat; (45:10:45, A:B:C)
flow rate: 2 mL/min
column temp.: 30 °C
detector: 225 nm cell: 11μL
injection: 10 μL
sample: itraconazol (1 mg/mL)

suitability

application for HPLC

application(s)

pharmaceutical (small molecule)

Legal Information

Chromolith is a registered trademark of Merck KGaA, Darmstadt, Germany

Analyte

Description

    Itraconazole impurity B
    Itraconazole impurity C/D
    Itraconazole impurity E
    Itraconazole
    Itraconazole impurity F
    Itraconazole impurity G

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