Development and Validation of a Stability-Indicating RP-HPLC Method for the Estimation of Aciclovir in Bulk and Ointment Dosage Form

Gunasekar Manoharan , Ramadan Abdel Wahed Mohamed

Abstract

A simple, precise and gradient RP- HPLC method has been developed and validated for Aciclovir in bulk and ointment formulation. The proposed method was validated to obtain official requirements including stability, accuracy, precision, linearity and selectivity. The estimation was developed on C (18) column reversed-phase using the mobile phase composition as Acetonitrile: Methanol: Phosphate buffer (16:20:64 v/v). The flow rate was set as 1ml/minute, and the maximum absorption was observed at 290 nm using Shimadzu SPD-20A Prominence UV-Visible detector.  The Aciclovir, drug showed a precise and good linearity at the concentration ranges of 20-100 μg/ml. The RP-HPLC assay showed the highest purity ranging from 99.79 % to 100.97 % for Aciclovir, ointment formulation, and 100.21 % was the mean percentage purity. The Aciclovir retention time was found to be 5.01 minutes. The method accuracy was shown by the statistical analysis.  To examine the stability of the drug, various forced degradation studies were conducted on Aciclovir ointment. The developed method was validated according to the ICH guidelines



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