A New Spectrophotometric Method for the Determination of Eflornithine Hydrochloride in Parenteral Formulation

Abstract

This work describes the development, validation and stable studies of a new, simple and reliable UV spectroscopy procedure for the analysis of eflornithine hydrochloride. A new rapid, precise, accurate, specific and simple UV Spectrophotometric analytical method was validated to assay eflornithine hydrochloride (DFMO) in parenteral. Measurements were taken at λmax 283 using ethanol as the solvent. Beer’s law is obeyed in the concentration ranges 4 – 32µg mL<SUP>-1</SUP> with a correlation coefficient (r) equal to 1. The values of limit of detection (LOD) were 0.0675µg mL<SUP>-1</SUP> and limit of quantification (LOQ) were 0.2045µg mL<SUP>-1</SUP> for DFMO respectively. The value of molar absorptivity and sandell’s sensitivity was 0.3918 × 104L mol<SUP>-1</SUP> cm<SUP>-1</SUP> and 0.1633µg cm<SUP>-2</SUP> respectively. The developed method was validated as per International Conference of Harmonization guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. The accuracy of the method was 100.23%. The precision demonstrated a relative standard deviation of less than 1%. The results were satisfactory when compared with the literature. The proposed method might be applied in routine quality control in the pharmaceutical industries since it is precise, accurate, simple and economic. Commercial formulation and laboratory prepared mixtures were successfully analyzed using the developed methods.