کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1224303 967918 2007 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
A high performance liquid chromatography method for vinorelbine and 4-O-deacetyl vinorelbine: A decade of routine analysis in human blood
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
A high performance liquid chromatography method for vinorelbine and 4-O-deacetyl vinorelbine: A decade of routine analysis in human blood
چکیده انگلیسی

A sensitive high performance liquid chromatographic method was developed and validated for the simultaneous quantification of vinorelbine and its active metabolite, 4-O-deacetyl vinorelbine, in human biological fluids. These two compounds together with vinblastine, used as internal standard, were extracted from blood and urine by a liquid–liquid process using diethyl ether, and followed by a back-extraction in acidic conditions. Then, they were analysed through a cyano column and detected in ultraviolet at 268 nm. The assay linearity was validated up to 2000 ng/ml. The lower limit of quantification was set at 2.5 ng/ml. The between-run precision and accuracy were always higher than 94%. Biological samples were stable when stored at −80 °C over 2 years. The long-term reproducibility and the suitability of this analytical method were demonstrated within the last decade through the analysis of about 7000 samples during the clinical development of i.v. and oral formulations of vinorelbine.Because vinorelbine binds mainly to platelets and blood cells and because this binding is rapidly reversible and highly influenced by environmental conditions, drug concentration in plasma may be highly influenced by the sampling conditions and the centrifugation process used to separate blood cells from plasma. Therefore, this method was developed in blood and then used for sample analyses in routine. The major benefit was that it was easy for nurses to directly collect blood instead of plasma and that reduced volume of sampling could be withdrawn from frail patients. Furthermore, the analysis in blood enabled to quantify vinorelbine and 4-O-deacetyl vinorelbine concentrations for a longer period of time, which resulted in a more accurate evaluation of pharmacokinetic parameters.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 44, Issue 1, 9 May 2007, Pages 144–149
نویسندگان
, , ,