Evaluation of Uncertainty in the Releasing Rate Determination of Fluvastatin Sodium Sustained-release Tablets
Objective:To evaluate the contribution of uncertainty in the releasing rate determination process of fluvastatin sodium sustained-release tablets. Methods:The experiment was conducted according to General Rule 0931 in Volume Ⅳ of the 2020 edition of Chinese Pharmacopoeia,and a mathematical model was established to analyze the source of uncertainty in the determination of fluvastatin sodium sustained-release tablets and calculate the synthetic uncertainty and extended uncertainty with reference to the relevant provisions of JJF 1059.1-2012. Results:The synthetic uncertainties of fluvastatin sodium sustained-release tablets at 0.5 h,2 h,4 h and 8 h were 0.02205,0.03034,0.03520 and 0.02979,respectively. The extended uncertainties were (5.9±0.26)％,(23.2±1.40)％,(54.8±3.86)％,(108.0±6.44)％ (k=2,confidence interval 95％),respectively. Conclusion:At 0.5h,2 h,4 h sampling points,the uncertainty contribution of fluvastatin sodium releasing rate in fluvastatin sodium sustained-release tablets comes mainly from the parallel determination of samples. At 8 h sampling point,it is mainly derived from the preparation of the test product solution. The uncertainty of the analysis method was quantified in this experiment,which provided a more scientific basis for the inspection of the releasing rate of controlled release tablets.
万方数据
维普
