Purpose: To develop and validate a
spectrophotometric method for the quantitative
determination of eflornithine hydrochloride as a pure
compound and in pharmaceutical formulations.
Methods: The method involved the
reaction of the target compound with vanillin reagent at
specific pH 5.6 to produce a green reddish color
chromogen. The derivative chromogen exhibits absorption
maxima at 578 nm. At the pH of the reaction, there was
no degradation. The developed method was validated as
per International Conference of Harmonization (ICH)
guidelines with respect to specificity, linearity, limit
of detection, limit of quantification, accuracy,
precision and robustness.
Results: Under the indicated
conditions, the proposed method was linear over the
concentration range of 5 - 25 μg/ml and the correlation
coefficient (r2) was > 0.998 (n = 6) with a
relative standard deviation (RSD) of 1.003 % (n = 6).
Mean recovery of the target compound was 100.58 % with a
limit of quantification (LOQ) of 4.3 μg/ml and limit of
detection (LOD) of 1.2 μg/ml.
Conclusion: The results demonstrate the
stability-indicating power of the proposed method which
is precise, accurate, simple and economic. Thus, the
method can be applied to the routine analysis of
eflornithine hydrochloride in bulk and pharmaceutical
formulations.
Keywords: Eflornithine hydrochloride,
Vanillin, Spectrophotometric assay, Validation, ICH
guidelines
