Asian Journal
Of Traditional Medicines

Abstract: A new compound named DHDK was isolated from Viscum coloratum and identified as (1E,4E)-1,7-bis(4-hydroxyphenyl)hepta -1,4-dien-3-one. DHDK, a new potential anti-tumor drug, was synthesized and prepared poly(ethylene glycol)-poly(D.L-lactic acid) (mPEG-PLA) micelles due to cytotoxic effects on a range of cancer cells. A revered phase liquid chromatographyic method has been developed and validated for the determination of potential related impurities in DHDK-loaded mPEG-PLA micelles. The micelles was subjected to the stress conditions of acid, base, oxidation, thermal and photolysis. The determination was achieved on Phenomenex SynergiTM 4 μm Fusion-RP 80Å (250 mm × 4.6 mm, 4 μm) with a gradient elution and the detection wavelength was set at 220 nm. Regression analysis shows as r value (correlation coefficient) of greater than 0.999 for DHDK and six potential impurities. Recoveries of impurities were found between 90.0% and 108.0%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness, which can be used for determination of related impurities in DHDK-loaded mPEG-PLA micelles.

Key words: DHDK, mPEG-PLA, RP-LC, process-related impurities, validation