Abstract for Post: Stability-Indicating RP-HPLC Method Development for Determination and Estimation of Valacyclovir in Raw and Tablet Formulation.
Author(s): Gunasekar Manoharan
A simple, gradient RP- HPLC method has been developed and validated for Valacyclovir bulk and tablet formulation. The method was validated to meet official requirements including selectivity, stability, linearity, precision and accuracy. Successful estimation was carried out for the drug product was developed on C(18) column reversed-phase using Phosphate buffer: methanol in the ratio (65:35 %. v/v) as mobile phase composition. The flow rate was adjusted to 1ml /minute and the absorption maxima were observed at 254 nm utilizing Shimadzu SPD-20A Prominence UV-Vis detector. Valacyclovir drug showed a good and precise linearity in the range 25-125 μg/mL. The HPLC, assay showed the purity ranging 99.49 to 100.17% for tablet formulation. The mean percentage purity was 99.95%. The chromatographic retention time of Valacyclovir was found to be 2.10 minutes. The statistical analysis showed the method accuracy. Various forced degradation studies were conducted on Valacyclovir International Conference on Harmonization (ICH) guidelines. The developed method can be successfully applied for estimation and determination of Valacyclovir in bulk and tablet formulations.