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

1, 1★★ Corresponding author

  1. 1Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.

CORRESPONDENCE

Raja Sundararajan

Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.

sraja61@gmail.com

Received: 18-04-2023; Revised: 21-05-2023; Accepted: 01-06-2023.

Volume 13, Issue 3 · pp. 617-624 · 2023 · DOI: 10.5530/ijpi.13.3.076

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.

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    Abhigna, G. V., & Sundararajan, R. (2023). Analytical Method Development and Validation for Determination of Valganciclovir by Using RP-HPLC. International Journal of Pharmaceutical Investigation, 13(3), 617-624. https://doi.org/10.5530/ijpi.13.3.076

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    © 2023 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. CC BY-NC-SA 4.0