Development and Validation of HPLC/DAD Method for Analysis of Erufosine

Objective:The aim of this study is to develop, validate and apply a high-performance liquid chromatography method with diode array detection (HPLC/DAD) for identification and quantification of anti-cancer agent Erufosine (erucylphosphoN,N,N-trimethylpropylammonium, ErPC3) which is the most recent and promising member of the alkyl phosphorylcholine family. Methods:HPLC/DAD method with isocratic elution using column C18 ODS, 250 × 4.6, 100 A, 5 μm, mobile phase Methanol/DI Water (85:15 v/v), flow rate 1.0 ml/min and UV detection at 206 nm. Results:The method was developed and validated in respect of analytical and chromatographic parameters specificity, repeatability, accuracy, limit of detection, limit of quantitation, linearity, system suitability test and robustness. The method is characterized by good reproducibility, accuracy and linearity in the specified concentration range of 1.0 µg – 1.0 mg. Conclusion: A fast, simple, accurate, precise, and linear HPLC method has been developed and validated for the simultaneous analysis of anti-cancer agent erufosine in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and European Pharmacopoeia 9.0 requirements. The method is of practical importance for development of identification and assay tests of Esufosune and also it could be used during the phase of clinical trials.