Development and Validation of Stability Indicating HPLC Method for Estimation of Valganciclovir

Namrata G. Bawaskar, Ayushi S. Gadekar, Anuruddha R. Chabukswar, Santosh V. Gandhi 1

8th WCPSDM.2021. APR.Published Online 18 APR 2021

Abstract : Valganciclovir is an antiviral drug used to treat cytomegalovirus infection. In the present study, a simple, sensitive, precise, rapid, specific, accurate and stability indicating HPLC method for the determination of valganciclovir in bulk and tablet formulation was developed and validated. The separation was achieved on C-18 column (250 x 4.6 mm, 5 μm. X-Bridge, Waters) using Ammonium Acetate Buffer pH 3 (adjusted with glacial acetic acid) and methanol (55:45 v/v) as mobile phase pumped with 1 ml/min flow rate and detection wavelength 254 nm. Retention time for the Valganciclovir was 6.5 min. Method was found to be linear in concentration range of 5-30 μg/ml with coefficient of correlation 0.9837. The % RSD values were < 2% indicating accurate, precise and robust method. LOD and LOQ was 0.52 μg/ml and 1.58 μg/ml, respectively. Force degradation studies were carried out various stress condition. The major degradation of valganciclovir was found under alkali and oxidative stress condition. The degradation pathway was studied using LC-MS spectra.