Valuation and Uncertainty Evaluation of the Purity Determination of Aminopyrine by Different Methods / 中国药师

ABSTRACT

Objective:To study the valuation and uncertainty evaluation of the purity determination of aminopyrine by two different principle methods. Methods:According to Technical Norm of Primary Reference Material and Technical Norm of Measurement,HPLC and acid-base titration were selected for studying the valuation of the purity determination of aminopyrine, and the uncertainty evaluation of the two different principle methods was systematically evaluated. Results:By using the two different principle methods,the standard value and uncertainty of aminopyrine content was 99.66% ± 0.08%(k = 2,P = 0.95). Conclusion:The valuation and uncertainty evaluation of the purity determination of aminopyrine by using HPLC and acid-base titration are accurate and reliable,which can avoid the defects by using single analysis method,and is helpful to improve the level of quality evaluation and control of aminopyrine. The study provides scientific basis for the development of aminopyrine purity reference materials.