A Validated Specific Reverse Phase Liquid Chromatographic Method for the Determination of Valacyclovir in the Presence of its Degradation Products in Bulk Drug and in Tablet Dosage Form

A specific, accurate, precise and sensitive validated reversed phase liquid chromatographic method has been developed for the determination of valacyclovir in the presence of its degradation products in bulk drug as well as tablet dosage form. As per ICH guideline Q1A (R2), drug was subjected to all stress conditions such as hydrolysis (acidic, neutral and alkaline), oxidation (3 % H2O2 v/v), photolysis (As per ICH guideline Q1B), thermal degradation and humidity study. All stressed samples were successfully analysed on C 8 column using mobile phase Acetonitrile: Phosphate buffer pH 3 (25 mM) in the ratio of 10:90 v/v. A flow rate was maintained at 1 ml/min and detection was made at 254 nm. The drug was found to degrade extensively in alkaline, acidic and oxidative conditions, and also in the presence of light (in alkaline environment). Mild degradation was found in neutral but the drug was stable to thermal, humidity stress. The developed method was validated over the linearity, precision, accuracy, ruggedness and specificity as per ICH guideline Q2B. The major degradants was identified as acyclovir through comparison with the standard. The developed method with good separation of all degradation products from drug could be successfully applied for the determination of valacyclovir in the presence of its degradation products in the bulk drug and tablets. It