甲硝唑口颊片中甲硝唑含量测定及其方法学研究

Determination of metronidazole content in metronidazole buccal tablets

目的采用HPLC法建立了甲硝唑口颊片的含量测定方法。方法采用Waters Sun FireTM C18(150mm×4.6 mm,5μm)色谱柱,甲醇-水(20∶80)为流动相,检测波长为310 nm,流速为1.0 ml/min。结果甲硝唑浓度在12.456～112.104μg/ml的浓度范围内线性关系良好(r=0.999 9),平均回收率(n=9)为101.6%。结论本方法准确、可靠,灵敏度高,适用于甲硝唑口颊片的质量控制。

Objective To establish an HPLC method for the determination of chlorzoxazone in metronidazole buccal tablets. Methods A Waters SunFireTM C 18 （ 150 mm × 4.6 mm, 5 μm） column was used. The mobile phase was methanol - water （20 ： 80） and he flow rate was 1.0 ml/min. UV detection wavelength was set at 310 nm. Results Chlorzoxazone had good linearity（ r = 0. 9999）within the range 12. 456μg/ml - 112. 104μg/ml. The average recoveries was 101.6%. Conclusion This method is accurate,reliable,sensi- tive and suitable for the quality control of metronidazole buccal tablets.