Validation of an HPLC method for the determination of valacyclovir in pharmaceutical dosage

A new analytical method was developed together with its validation study, by means of a high resolution liquid chromatography (HPLC) of reverse phase to quantify valacyclovir L-Valine, ester with 9-[(2-hydroxyethoxy)methyl]guanine hydrochloride in tablets. Determination was carried out by means of an ODS C-18 column (Microsorb-MV(TM)100 A, 10 mum, 25 cm x 4.6 mm); the mobile phase consisted of acetic acid in water (I : 1000): methanol (70: 30). It was pumped through the chromatographic system at a flow rate of 1.0 mL/min. The UV detector was operated at 254 nm. The validation study was carried out fulfilling the ICH guidelines in order to prove that the new analytical method meets the reliability characteristics, and these characteristics show the capacity of an analytical method to keep, throughout the time, the fundamental criteria for validation: selectivity, linearity, precision, accuracy, and sensitivity. The method is applied during the working day for the quality control of commercial valacyclovir tablets in order to quantify the drug and to check the uniformity content test.