Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Development of a visible spectrophotometric method for the analysis of ganciclovir in bulk sample and dosage form

Olusegun E Thomas, Olajire A Adegoke

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria;

For correspondence:- Olajire Adegoke Email: ao.adegoke@mail.ui.edu.ng Tel:+2348036381625

Received: 23 June 2014 Accepted: 24 April 2015 Published: 29 June 2015

Citation: Thomas OE, Adegoke OA. Development of a visible spectrophotometric method for the analysis of ganciclovir in bulk sample and dosage form. Trop J Pharm Res 2015; 14(6):1095-1101 doi: 10.4314/tjpr.v14i6.23

© 2015 The authors.
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Abstract

Purpose: To develop and validate a simple visible spectrophotometric method for the quantitative determination of ganciclovir in bulk sample and dosage form.

Methods: The method was based on the diazo coupling reaction between diazotized ganciclovir and acidified p-dimethylaminobenzaldehyde. Various analytical parameters for the azo adduct were established. Validation of the new method was carried out using current ICH guidelines with parameters including linearity, repeatability, reproducibility and selectivity determined. The developed method was thereafter applied to determine ganciclovir in a commonly available brand.

Results: Coupling reaction generated a yellow-coloured product in an alcohol medium with optimal wavelength at 404 nm. Linear correlation was obtained at concentrations of 10.3 - 25.7 µg/mL. The method was accurate and precise with recovery in the range of 99.37 - 103.15 % while intra- and inter-day precision (% RSD) at three different concentrations was < 2.7 %. The limits of detection and quantification were 0.23 and 0.70 µg/mL, respectively. When applied to the analysis of the dosage form, there was no statistically significant difference between the new method and the official HPLC method.

Conclusion: The method is simple, inexpensive, reproducible and fast, and can be employed as a reliable alternative to the official method for the routine analysis of ganciclovir in bulk and dosage forms.

Keywords: Ganciclovir, p-dimethylaminobenzaldehyde, Diazo coupling reaction, Absorption spectrophotometry