Verification of the Zinc Oxide Assay Method in Simanovsky Ointment for its Chemical Stability Estimation

Abstract

Stability is the main quality parameter of any medicine. The literature contains a large number of methods for the known active ingredients analysis, but often there is no information about their use in the separate dosage forms analysis. The Simanovsky ointment often is being prepared in pharmacies of Ukraine. One of its main active ingredient is zinc oxide. Verification of the zinc oxide assay method in the medicine composition was done for proving the possibility of its use for the ointment chemical stability analysis.Optimal approach to ointment sample preparation was chosen. The complexometry method was used for the zinc oxide assay in the ointment. The obtained values of all method validation parameters don’t exceed the permissible criteria. The requirements for accuracy (δ,%=0.51≤1.02) and precision (∆_Z=1.13≤3.20) are fulfilled. The method was tested on the ointment samples. Obtained RSD value (RSD=0.37 %) proves the good reproducibility of the results.