Analytical Method Development and Validation for Determination of Valganciclovir by Using RP-HPLC

Abstract

Objectives: A novel, precise, and accurate RP-HPLC method was developed and validated for the determination of valganciclovir in pure and medicinal dose form. Cytomegalovirus infections were treated with the antiviral medication valganciclovir. Ganciclovir was first phosphorylated by viral protein kinase into the monophosphate form in cytomegalovirus-infected cells. Afterwards, it was converted to its triphosphate form by cellular kinases.Materials and Methods: The analyte separation was obtained by Shimadzu C18 column. Mobile phase was in the ratio (20:80v/v) of acetonitrile and 0.05% of orthophosphoric acid. Flow rate of 0.6mL/min was used. The wavelength of the drug was at 254nm with a retention time of 3. 761 min.Results: The regression equation of valganciclovir was found to be y=56286x+50633, with a R2 value of 0. 9993. It was reported that the precision percent RSD was under 2%. The rate of valganciclovir recovery was 99.43%. Valganciclovir LOD and LOQ were determined to be 0.1 µg/mL and 0.3µg/mL, respectively.Conclusion: The proposed method was shown to be exact, accurate, and perfect for usage in QC labs for quantitative analysis of pharmaceutical dosage forms, both single and combined.

Keywords: Valganciclovir; C18 column; Validation; Method development