Determination and Validation of Eflornithine Hydrochloride by (Rp-Hplc) Reversed Phase High Performance Liquid Chromatography

Amit Kumar¹, Vijender Singh² and Praveen Kumar^3,

¹Department of Pharmaceutical analysis, NKBR College of Pharmacy & Research Centre, Meerut, India

²Department of Pharmaceutical analysis, BBS Institute of Pharmaceutical & Allied Sciences, Greater Noida, India

³Department of Pharmaceutical Chemistry, S. D. College of Pharmacy and Vocational Studies, Muzaffarnagar, India

Cite this paper:
Amit Kumar, Vijender Singh and Praveen Kumar. Determination and Validation of Eflornithine Hydrochloride by (Rp-Hplc) Reversed Phase High Performance Liquid Chromatography. American Journal of Pharmacological Sciences. 2013; 1(5):90-95. doi: 10.12691/ajps-1-5-4

Abstract

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.

Keywords:
eflornithine hydrochloride (DFMO) Validation ICH guidelines HPLC

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