Development and Validation of an RP-HPLC Method for the Determination of Valacyclovir in Tablets and Human Serum and Its Application to Drug Dissolution Studies

摘要

A specific, sensitive, simple, and rapid HPLC method has been developed for the determination of valacyclovir (VACL) in raw material, pharmaceutical dosage forms, and human serum, in order to carry out drag dissolution studies from tablets. The chromatographic separation was achieved with acetonitrile : methanol: 0.067 M KH-2PO-4 (27:20:53, v/v/v) adjusted to pH 6.5 with 3 M NaOH as mobile phase, a Waters Spherisorb C18 column, and UV detection at 244 nm. Etodolac was used as an internal standard. Linearity range was 5-20,000 ngmL~-1. Limit of detection obtained was 0.38 and O.14ngmL~-1 in mobile phase and spiked human serum samples, respectively. The described method can be readily applied, without any interferences from the excipients, for the determination of the drug in tablets, human serum samples, and drug dissolution studies.