Development and Validation of a Spectrophotometric Method for Quantitative Determination of Ganciclovir in Pharmaceutical Formulations

International Journal of Chemistry | Vol. 10, No. 6, June 2019 | pp. 41–48

DOI: 10.46882/2019/IJC/000128

Article Type: Original Research Paper

Title: Development and Validation of a Spectrophotometric Method for Quantitative Determination of Ganciclovir in Pharmaceutical Formulations

Names of Authors: E. O. Effiong¹, J. M. S. Cardoso²*

Authors’ Affiliations:
¹Department of Chemistry, University of Uyo, Uyo, Nigeria.
²Department of Pharmacy, University of Coimbra, Coimbra, Portugal.

Abstract: Developing rapid, low-cost analytical protocols is essential for routine quality monitoring and the detection of substandard antiviral formulations in clinical testing laboratories. This paper describes the development and validation of a simple UV-Vis spectrophotometric method for the quantification of ganciclovir in pharmaceutical injections. The analytical procedure relied on the reaction of ganciclovir with 1,2-naphthoquinone-4-sulfonate in an alkaline medium, generating a highly stable orange-colored derivative monitored spectrophotometrically at its absorption maximum of 460 nm. Method validation parameters followed the International Council for Harmonisation (ICH) guidelines. Excellent linearity was established over a concentration range of 2.0 to 25.0 mg/L with a correlation coefficient (R²) of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.08 mg/L and 0.24 mg/L, respectively. Precision assessments yielded relative standard deviations (RSD) below 1.8%. The validated method was successfully applied to screen commercial brands of ganciclovir formulations, producing recovery percentages between 98.6% and 101.4% with no interference from common excipients, making it suitable for routine quality control setups.

Keywords: UV-Vis spectrophotometry; Ganciclovir; Chemical derivation; Method validation; Pharmaceuticals; Quality control

Manuscript Timeline: Received: June 12, 2018; Revised: July 25, 2018; Accepted: August 18, 2018; Published: June 03, 2019.

Citation: Effiong, E. O., & Cardoso, J. M. S. (2019). Development and Validation of a Spectrophotometric Method for Quantitative Determination of Ganciclovir in Pharmaceutical Formulations. International Journal of Chemistry, 10(6), 41–48.

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