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A validated reversed phase HPLC method for determination of
process-related impurities in DHDK-loaded mPEG-PLA micelles
Peipei Yu, Jing Hong, Ceng Zhou, Jingtao Zhao, Lin Meng, Zhiguo Yu, Yunli Zhao
2019 (2):
82-91.
摘要
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508 )
PDF(948KB)
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369
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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.
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