Results and discussion on various laboratories proficiency-testing for assays of bismuth potassium citrate capsules by complexometric titration
Objective:To design the proficiency testing(PT)project(No.NIFDC-PT-183)for assays of bismuth potassium citrate capsules and organize to assess the proficiency of complexometric titration in laboratories,and pro-vide some technical analyses and advices.Methods:Two groups of samples with different concentration were pre-pared.The uniformity was evaluated with one-way analysis of variance and the stability was confirmed with t-test,whose results all conformed the requirements.The samples with three combinations were randomly distributed to 279 laboratories.The determination was performed according to the assays of bismuth potassium citrate capsules in Volume Ⅱ of the Chinese Pharmacopoeia 2015.The median value and normalized interquartile range(NIQR)of robust statistical analysis was adopted and Z-scores were used to evaluate the results from each of laboratories.Results:Among 279 laboratories,240 laboratories results were satisfactory,23 were questionable,and the other 16 were unsatisfied.The satisfaction rate was 86.0％.Conclusion:The overall capacity of national laboratories for assays of bismuth potassium citrate capsules is good.while a portion of participants require further improvement.
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