Purity Determination and Uncertainty Evaluation of Ribavirin Purity Reference Material / 医药导报

ABSTRACT

Objective To develop the ribavirin purity certified reference material( CRM ) which has measurement traceability and high accuracy,and establish an effective method of evaluation. Methods The homogeneity and the stability were checked by differential scanning calorimetry(DSC). High performance liquid chromatography(HPLC)and DSC methods were used for purity determination of ribavirin. Results Ribavirin showed satisfactory homogeneity and stability. The certified value of ribavirin was 99. 5%with an uncertainty of 0. 4%(k=2,P=0. 95). Conclusion Ribavirin purity CRM obtained in this paper has been proven to be a national primary CRM with high accuracy and traceability,which can be used to validate analytical methods,improve the accuracy of measurement data,establish meteorological traceability of analytical results as well as control the quality of ribavirin in the pharmaceutical industry.