Stability comparison between a novel polyethylene glycol mediated lipid nanoemul-sion of docetaxel and docetaxel injection saline dilutions / 药学实践杂志

ABSTRACT

Objective To establish HPLC method to detect docetaxel and compare the stability of a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel with docetaxel injection saline dilutions .Methods HPLC method was estab‐lished to detect docetaxel concentration .The stability of a novel polyethylene glycol mediated lipid nanoemulsion of docetaxel and docetaxel saline dilutions were investigated by drug concentration pH value and particle size using membranes filtration method .Results The linear range of docetaxel was 1‐256 μg/ml ,regression equation was Y=21 .199X+20 .488 ,r=0 .999 9 . The drug concentration pH value and particle size of polyethylene glycol mediated lipid nanoemulsion of docetaxel was stable at room temperature in 24 hours .However the docetaxel injection saline dilutions was discovered drug precipitation in about two hours after preparation and the drug concentration was significant decreased in the filtration of docetaxel injection saline dilu‐tions .Conclusion The novel polyethylene glycol mediated lipid nanoemulsion of docetaxel was a new stable docetaxel formula‐tion and significantly increased the safety in clinical .