Quality Analysis of Piroxicam Tablets / 中国药师

ABSTRACT

Objective: To evaluate the quality status of piroxicam tablets. Methods: The samples were examined by the statutory standard,and the exploratory studies were carried out. The results were statistically analyzed. Results: Totally 138 batches were exam-ined according to the statutory standard, and among them, 135 batches were qualified with the qualified rate of 97. 8% . The unquali-fied item of 3 unqualified batches was dissolution. The exploratory studies showed that there were two crystal forms of piroxicam used in the tablets, and the dissolution of the two crystal forms was different with form 1 less than form 2. An inspection method for the relative substance was established. Totally 14 impurities were detected out and the structures of 8 impurities were identified. The impurities were mainly derived from the raw materials, and many batches of samples were with single largest impurity content exceeding 0. 5% , and the total of impurity content above 1. 0% . A class I solvent 1,2-dichloroethane was detected out in 13 batches of tablets by GC and confirmed by GC-MS. Through the dissolution consistency test, it was found that there was a great difference in the dissolution behavior among the products from different manufacturers. Conclusion: The overall quality of piroxicam tablets is not ideal, and the production process of some manufacturers needs to be improved.