Redox-based Spectrophotometric Method for the Determination of Ganciclovir in Bulk and Pharmaceutical Dosage Form

Background: Ganciclovir is a synthetic analogue of 2′-deoxy- guanosine, used in the treatment of cytomegalovirus infection. The aim of the present investigation was to develop and validate a simple, rapid and sensitive redox-based spectrophotometric method for the quantification of Ganciclovir in pure and in pharmaceutical dosage form.

Methods: It was developed by using 0.1 M HCl as solvent and mixture of ferric chloride and 1,10-phenanthroline as chromogenic reagent. The developed method was optimized for various method conditions and then statistically validated.

Results: The mixture containing 0.3% w/v of ferric chloride and 0.5% w/v of 1,10-phenanthroline and drug to reagent mole ratio of 0.5:0.5, were identified as optimum for the method, based on the optimization studies. Linearity of the method was found to be 5.0-30.0 μg/mL for Ganciclovir, when the measurement was done at 510.0 nm. The method was proved to be sensitive by its low limit of detection and quantification values i.e., 0.30 and 0.90 μg/mL, respectively. The results of the validation parameters comply with the ICH guidelines. The %assay value 99.2 indicated the successful adaptation of the contemplated method for the pharmaceutical formulation.

Conclusion: The developed method was simple and could be applied in the quality control testing of Ganciclovir in formulation.