格列齐特片(Ⅱ)的质量分析

目的: 评价国内格列齐特片(Ⅱ)的质量状况。 方法: 通过对格列齐特片(Ⅱ)的标准化检验和探索性研究考察其质量状况。 结果: 通过探索性研究发现,现行标准ChP2005的含量测定方法为电位滴定法,操作繁琐耗时、污染严重,不利于高通量测定,改用高压空气吹干后明显提高检验速度,同时并不影响检验结果准确性。电位滴定法受到的干扰因素较多,采用HPLC法测定含量,结果准确度与原方法有很好的一致性。 结论: 该品种质量状况总体评价良好,现行检验标准可行,建议格列齐特片(Ⅱ)的含量测定更改为HPLC法。

Objective: Evaluate the quality of the Gliclazide tablets(Ⅱ). Methods: Through the test and the exploratory research to evaluate its quality. Results: Through the exploratory research,we found the potentiometric titration of assay is not appropriate for the high-throughput assay,use the high-press drying can improve the test speed markedly,and does not affect the accuracy of the results.But the HPLC have the good consistency with the original method. Conclusion: The original standards is feasible and the quality is good.We suggest the assay for Gliclazide Tablets(Ⅱ) can be used HPLC.