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Abstract

A rapid, sensitive and specific RP-HPLC method involving UV detection was developed and validated for determination and quantification of Eflornithine hydrochloride in tablet dosage form.  Chromatography was carried out on a pre-packed Thermo Hypersil C18 (5µm, 250x4.6mm) column using filtered and degassed mixture of Acetonitrile:Buffer (900:100) as mobile phase at a flow rate of 0.8ml/min and effluent was monitored at 210nm. The buffer was prepared by dissolving 6.8gm of potassium dihydrogen orthophosphate in 100ml of water and the pH was adjusted to 5.0 by using O-phosphoric acid.  The method was validated in terms of linearity, precision, accuracy, and specificity, limit of quantification and limit of detection.  The assay was linear over the concentration range of 125mcg-750mcg/ml.  Accuracy of the method was determined through recovery studies by adding known quantities of standard drug to the pre analysed test solution and was found to be 100.30%-101.48% within precision RSD of 0.32 for Eflornithine hydrochloride.  The system suitability parameters such as theoritical plates, resolution and tailintg factor were found to be 9093.00, 1.4 and 1.08 respectively and the LOD and LOQ of Efflornithine hydrochloride were found within the limit(less than 2%).  The method does require only 10 minutes as run time for analysis which prove the adoptability of the method for the routine quality control of the drug.

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	JPR Solutions

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