Abstract

CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION STABILITY-INDICATING FIVE IMPURITIES AND ITS DEGRADATION PRODUCTS IN VALGANCICLOVIR HYDROCHLORIDE POWDER FOR ORAL SOLUTION, 50 MG/ML

*†Naresh Chandra Reddy Male and ††Kavitha Male

Abstract

A Novel RPHPLC Quantification method was developed for estimation of Valganciclovir HCl known impurities like its Ganciclovir, Guanine, Bis Valine Ester, Methoxymethylguanine and Monoacetoxyganciclovir which, were separated on Zorbax SB C18, 150 mm x 4.6 mm, 3.5 μm. Using a mixture of Ammonium Phosphate Monobasic buffer and Methanol as a gradient mobile phase with a flow rate of 1.0 ml/min; λ max at 254 nm. The developed method was validated all the parameters like linearity, specificity, LOD, LOQ, accuracy, robustness, ruggedness , precision, filter variation, solution stability and forced degradation studies.

Keywords: Method development and validation, Valganciclovir HCl, Related substances, Stability-indicating, Powder for oral suspension.