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A validated ultra-HPLC-MS/MS method for determination of honokiol in human plasma and its application to a clinical
Quankun Zhuang1,2, Ruili Pan3, Xuemei Liu1,2
1Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, PR China.
Abstract:
Aim: To investigate pharmacokinetics of honokiol after administration of honokiol liposome injection (HKLI) and support the clinical studies of HKLI; it is crucial to determine the concentration of honokiol in human biological samples. Experimental method & results: Human plasma samples were extracted by protein precipitation and analyzed by a new ultra-HPLC-MS/MS (UPLC-MS/MS) method with LLOQ of 0.5 ng/ml. The method was validated according to bioanalytical guidelines from the US FDA and EMA. Successful method validation proved that the method was sensitive and selective, and was suitable for determination of honokiol in clinical plasma samples. Conclusion: The method was successfully applied to evaluate the pharmacokinetics of honokiol after administration of HKLI to Chinese subjects with advanced non-small-cell lung cancer in a first in-human study.
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