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

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.

Application of Hantzsch reaction for sensitive determination of eflornithine in cream, plasma and urine samples

“…Therefore, the estimation of EFN in various biological media has a particular value for investigating pharmacodynamics and pharmacokinetics as well as monitoring the absorption and tissue uptake of EFN in both pre-clinical and clinical research [11]. A survey of the literature explained that there are several analytical chromatographic methods such as LC-evaporative light scattering detector [12], LC-UV detector [13][14][15], LC-MS/MS detector [16] and few spectrophotometric methods (UV and colorimetric) [17][18][19][20] have been reported to estimate EFN. In addition, one enzyme-linked immunosorbent assay method [21] and one electrochemical method also have been reported [11].…”

“…In addition, one enzyme-linked immunosorbent assay method [21] and one electrochemical method also have been reported [11]. However, the expensive cost, the time loss, ultrafiltration, the harmful organic solvents consumption and the sophisticated laboratory set-up are known to be the major drawbacks of the abovementioned liquid chromatographic methods [12][13][14][15][16]. In addition, the reported spectrophotometric methods are limited to analyse the cited drug in vials dosage only without broaching to cream samples or the biological fluid analysis [17][18][19][20].…”