Evaluation of uncertainty measurement for the determination of ribavirin by HPLC

Objective:To set out the procedure for estimation of measurement uncertainty for the determination of ribavirin by HPLC.Methods:To facilitate the identification and analysis of the uncertainty sources arising from the procedure of analysis,a cause and effect diagram was constructed and simplified.Each uncertainty component, whether associated with individual sources or with the combined effects of several sources,was evaluated with re- spect to the significance of its contribution to the overall measurement uncertainty and was expressed as standard un- certainty.All the standard uncertainties were then combined according to the appropriate rules to give a combined standard uncertainty and an expanded standard uncertainty.Results:The expanded standard uncertainties for the HPLC determination of ribavirin in injections is 1.6%×Q%.Conclusion:Measurement uncertainty is applicable to set the limit of the ribavirin in injections.The establishment of the methodology for the evaluation of measurement uncertainty is important to the studies of Chinese medical standards.