Science and Education Publishing American Journal of Pharmacological Sciences 1 5 2013 12 11 Determination and Validation of Eflornithine Hydrochloride by (Rp-Hplc) Reversed Phase High Performance Liquid Chromatography 90 95 EN Amit Kumar Vijender Singh Praveen Kumar Department of Pharmaceutical Chemistry, S. D. College of Pharmacy and Vocational Studies, Muzaffarnagar, India AJPS2013154 10.12691/ajps-1-5-4 2013 05 05 2013 12 02 2013 12 11 A simple highly sensitive, rapid, precise, accurate and specific RP-HPLC method was developed for quantification of eflornithine hydrochloride (2-difluoromethyl-DL-ornithine; DFMO) in its commercial formulation. In this RP-HPLC method, the separation was performed using BDS Hypersil 5µ C18 (150 X 4.6 mm) column at room temperature by using methanol: 2% of Glacial acetic acid in water (80:20 v/v) as mobile phase. The flow rate was 0.8 mL min-1 with UV detection at 290 nm. The retention time of DFMO was 4.3. Linearity was observed over concentration range of 50-100 µg mL-1 for DFMO. The LOD and LOQ were found to be 0.008438 µg mL-1 and 0.028126 µg mL-1 respectively. The accuracy of the proposed method was determined by recovery studies and found to be 100.5 % for DFMO. The proposed method was validated for ICH guidelines like linearity, limit of detection, accuracy, precision, ruggedness, robustness, and system suitability.