کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
7627107 | 1494582 | 2018 | 16 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Identification, characterization and HPLC quantification of formulation-related impurities of honokiol, an antitumor natural drug candidate in clinical trials
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Natural products and their derivatives have historically been invaluable as a source of therapeutic agents. Honokiol, as a well-known natural product in Chinese herbal medicine Houpu, is finally being studied in a Phase I clinical trial (CTR20170822) in patients with Advanced Non-Small Cell Lung Cancer (NSCLS) in China this year. During the honokiol liposome formulation process, five major impurities were present in the range of 0.05-0.1% based on the HPLC analysis. These five major impurities were obtained from the forced degradation product of honokiol through countercurrent chromatography and prep-HPLC. The structure were elucidated with 1H NMR, 13C NMR, 2D NMR and MS spectral data. The proposed HPLC method was validated for specificity, linearity (concentration range 0.01-1.62, 0.003-0.96, 0.05-7.98, 0.04-6.52, 0.03-5.18â¯Î¼g/ml for impurities I-V respectively, R2â¯>â¯0.9988), accuracy (99.11-100.67%), precision (CVâ¯<â¯1.6%), and sensitivity (LOD 3.3, 0.1, 16.7, 13.3, 10.0â¯ng/ml for impurities I-V respectively). The validated method was employed in the further study of the honokiol drug substance.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 153, 10 May 2018, Pages 186-192
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 153, 10 May 2018, Pages 186-192
نویسندگان
Wenshuang Wu, Ming-Hai Tang, Huan Tang, Kai Chen, Jie Fu, Lun Wang, Lin-Lin Xue, Aihua Peng, Haoyu Ye, Li-Juan Chen,