质量控制图在甲硝唑片含量测定中的应用

Application of Quality Control Chart in Determination of Metronidazole Tablets

目的利用质量控制图对甲硝唑片含量测定的过程进行控制。方法采用高效液相色谱法测定质控样甲硝唑片的含量,将测定数据绘制成控制图,并用于甲硝唑片样品含量测定过程的质量控制。结果控制图(X图)的行动限为95.49%～100.65%,警告限为96.35%～99.79%。结论利用质量控制图有助于及时发现检测过程中异常因素,有效控制检测结果质量,保证检测数据的准确、可靠。

Objective Quality control chart was used to monitor the process of determination of metronidazole tablets. Methods To determine the content of the control sample of metronidazole tablets by HPLC, the data were drawn into control chart to monitor the process of determination. Results The action limit of the control chart （X chart） was 95.49%-100.65%, and the warning limit was 96.35%-99.79%. Conclusion Using quality control chart is helpful to identify the abnormality in the process of determination in time, control the test results and ensure the accurate and reliable testing data.