Determination of the impurity profile of 1,2-cyclohexanedione dioxime by high-performance liquid chromatography

Add time:08/13/2019    Source:sciencedirect.com

High-performance liquid chromatography (HPLC) was used to determine the impurity profile of 1,2-cyclohexanedione dioxime (CDO), a key ingredient in the radiopharmaceutical CardioTec® kit (kit for the preparation of 99mTc teboroxime). The HPLC assay separated CDO from potential impurities which included 1,2-cyclo-hexanedione, cyclohexanone monoxime and cyclohexanedione monoxime (CDM). The method employed a mobile phase consisting of 0.1% phosphoric acid-acetonitrile (82:18, v/v), a Hamilton 10-μm PRP-X100 anion-exchange column (250 × 4.1 mm I.D.), and UV absorbance detection (238 nm), and achieved a resolution (Rs) ⩾ 1.5 for the three detected impurities: 1,2-cyclohexanedione, cyclohexanone monoxime and cyclohexanedione monoxime (CDM) in the presence of CDO. The method was improved compared to existing methods by achieving a rapid, simultaneous separation (15 min) of compounds not previously reported and quantitating impurities at the 0.2–5% (w/w) level of sensitivity.

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