摘要
目的为吡嗪酰胺片含量测定建立新的质量控制方法。方法采用高效液相色谱法(HPLC)测定吡嗪酰胺片中吡嗪酰胺的含量。色谱柱:Agilent C18(250 mm×4.6 mm,5μm),流动相:甲醇-水(10:90),检测波长269 nm,流速1.0mL/min,柱温30℃,理论板数按吡嗪酰胺峰计算应不低于3000。结果在2.024~20.24μg/mL浓度范围内,吡嗪酰胺进样量与峰面积呈良好的线性关系,r=0.9999,平均回收率为99.8%(n=6),RSD=0.8%。结论本法简便、准确,重现性及灵敏度高,可用于吡嗪酰胺片中吡嗪酰胺的含量测定。
Objective To build a new quality control method for pyrazinamide tablets. Methods HPLC was adopted todetermine pyrazinamide content in pyrazinamide tablets. Agilent C18 column (250 mm × 4.6 mm, 5 μm) was used, with methanol:water (10:90) as mobile phase. The flow rate was 1.0 mL/min. The detecting wavelength was 269 nm and the column temperature was 30 ℃. The column efficiency determined from the pyrazinamide' s peak was not less than 3000 theoretical plates. Results The linear concentration range for pyrazinamide analysis was 2.024-20.24 μg/mL, r=0.9999. The average recovery was 99.8 % (n=6), with RSD of 0.78 %. Conclusion This method is simple and precise, with high repeatability and sensitivity, so it can be used in the content determination of pyrazinamide in pyrazinamide tablets.
出处
《食品与药品》
CAS
2013年第3期194-196,共3页
Food and Drug