Quantitation of Anti-Cancer Drugs in human plasma by LC-MS/MS. Bioequivalence Studies of Anti-Cancer Drugs by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

      Аннотация: The successful hyphenation of LC and MS has had an enormous impact in the field of quantitative analysis of anticancer agents from biological samples. LC-MS/MS has become an important tool in cancer research, both in fundamental and clinical studies. The development and validation of bioanalytical LC-MS/MS method suitable for quantitation of the selected drugs (Capecitabine, Etoposide, Lapatinib, Methotrexate and 6-mercaptopurine) in biological matrices is discussed in this book. The different aspects of these assay methods viz. extraction, instrumentation, total turn-around time and sensitivity, selectivity etc. were assessed. Systematic validation as per USFDA guidelines is done for all the methods. The bioequivalence study is conducted with test and reference formulation of the methotrexate and 6-mercaptopurine on healthy human subjects. The pharmacokinetic parameters investigated include Cmax, Tmax, t1/2, AUC and Kel. This study is conducted strictly in accordance with guidelines laid down by International Conference on Harmonization and USFDA.

Ключевые слова: quantification, Anti-cancer drugs, human plasma, LC-MS/MS, Pharmacokinetic/ Bioequivalence Study