eng Science and Education Publishing American Journal of Pharmacological Sciences 2013-12-11 1 5 90 95 10.12691/ajps-1-5-4 AJPS2013154 article Amit Kumar 1 Vijender Singh 2 Praveen Kumar praveensha77@gmail.com 3 Department of Pharmaceutical analysis, NKBR College of Pharmacy & Research Centre, Meerut, India Department of Pharmaceutical analysis, BBS Institute of Pharmaceutical & Allied Sciences, Greater Noida, India Department of Pharmaceutical Chemistry, S. D. College of Pharmacy and Vocational Studies, Muzaffarnagar, India 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. http://pubs.sciepub.com/ajps/1/5/4/ajps-1-5-4.pdf eflornithine hydrochloride (DFMO)ValidationICH guidelinesHPLC