Abstrakt

Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Valganciclovir Hydrochloride (RS).

Krishna Veni N, Gowramma B, Madhuri L, Gouthami B, Sindhur Nag N and Meyyanathan SN

A specific, accurate, precise and sensitive stability indicating RP HPLC method was developed and validated for the determination of Valganciclovir hydrochloride (RS) in bulk drug and pharmaceutical dosage form in the presence of its degradation products. An isocratic RP HPLC method was developed with a Hibar C18 (250 X 4.6 mm i.d., 5μ) and methanol: 25mM Ammonium acetate (pH 3.0, adjusted with acetic acid) in the ratio of 10:90 % v/v as mobile phase. The flow rate was maintained at 1 mL min-1 and detection was carried out using PDA detector (254 nm). The drug was subjected to stress conditions of degradation in aqueous solutions including hydrolysis, oxidation and photolysis. Degradation was carried out for 24 hrs at 60°C. The drug was found to degrade extensively under alkaline hydrolysis and oxidation with hydrogen peroxide. Mild degradation was observed in neutral but the drug was stable to photolysis. The developed method was validated with respect to linearity, precision, accuracy, ruggedness and specificity.