Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

Development and Validation of Stability Indicating RP-Liquid Chromatographic Method for the Quantitative Determination of Valganciclovir

Author(s): Sreenivasulu Sura, Rameswara Rao Modalavalasa, Chandra Sekhar KB

A new simple stability indicating and user friendly RP-Liquid Chromatographic method was developed for the accurate and precise determination of Valganciclovir using Phenomenex Gemini-NX C18 Column (250 mm Length × 4.6 mm diameter × 5 μm particle size) and variable wavelength (UV) detector. The mobile phase used for the study was sodium Citrate buffer:Methanol in a ratio of 40:60 v/v with a flow rate of 1.0 ml/min. Valganciclovir was detected at wavelength 254 nm and eluted at 2.18 ± 0.5 min. The developed method is linear over 10-80 μg/ml concentration range and correlation co-efficient (r2) obtained as 0.9996. The tailing factor and plate count was found 1.32 and 3649 respectively. The proposed method was proven as robust after its extensive validation, which involves various parameters such as Precision, Linearity, Accuracy, Ruggedness, Robustness, Limit of Detection (LOD), Limit of Quantification (LOQ) and specificity. The developed and validated method is definite and reproducible, can be used for routine analysis of Valganciclovir in bulk form.


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