RP-HPLC METHOD DEVELOPMENT & VALIDATION OF ACYCLOVIR (ACY) IN PHARMACEUTICAL FORMULATION

Radhika Vasantrao Kharat*, Dr. S. C. Kale, Dr. K. R. Biyani

ABSTRACT

Acyclovir is a deoxynucleoside analog antiviral used to treat herpes simplex, Varicella zoster, herpes zoster, herpes labialis, and acute herpetic keratitis herpesvirus. It has a wide therapeutic window and is slightly soluble in water and organic solvents like DMSO and dimethyl formamide. Acyclovir is converted into acyclovir monophosphate by viral thymidine kinase, and then into acyclovir triphosphate by various enzymes. Acyclovir triphosphate has a higher affinity for viral DNA polymerase than cellular DNA polymerase, incorporating it into the DNA where the missing 2' and 3' carbons cause DNA chain termination. The present study focuses on developing and validating a RP-HPLC method for estimating Acyclovir in pharmaceutical formulations, aiming to apply suitable analytical techniques, optimize them, validate the method according to ICH guidelines, and select the drug. Research shows that the RP-HPLC method is a viable option for accurately measuring Acyclovir (ACY) in medicinal dose tablet forms. Reproducibility is a strong suit of the RP-HPLC technique, which also happens to be sensitive, accurate, precise, and repeatable. Acyclovir (ACY) tablet dose formulation analysis may also be executed effectively. These techniques do not experience any influence from additives, matrices, etc. These results could be better understood with more research on other pharmacological formulations.

Keywords: Acyclovir; RP-HPLC; Validation; ICH guidelines; antiviral drug.