Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Spectrophotometric Determination of Eflornithine Hydrochloride using Vanillin as Derivative Chromogenic Reagent

Amit Kumar¹ , Vijender Singh², Praveen Kumar³

¹Department of Chemistry, NKBR College of Pharmacy & Research Centre, Meerut, Uttar Pradesh-245206; ²Department of Chemistry, BBS Institute of Pharmaceutical & Allied Sciences, Noida-201306; ³Department of Chemistry, MET-Faculty of Pharmacy, Moradabad, Uttar Pradesh-244102, India.

For correspondence:- Amit Kumar Email: amitanalysis@yahoo.co.in Tel:+919897144639

Received: 19 December 2013 Accepted: 28 September 2014 Published: 24 November 2014

Citation: Kumar A, Singh V, Kumar P. Spectrophotometric Determination of Eflornithine Hydrochloride using Vanillin as Derivative Chromogenic Reagent. Trop J Pharm Res 2014; 13(11):1917-1923 doi: 10.4314/tjpr.v13i11.21

© 2014 The authors.
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Abstract

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