摘要
目的建立新生颗粒中马兜铃酸A的限量检查方法,以保证临床用药的安全性。方法采用高效液相色谱法,色谱柱:Phenomenex Luna C18(2)(4.6mm×250mm,5μm);流动相:甲醇-3.3%醋酸(75∶25);流速:1.0mL/min;柱温:室温(25℃);检测波长:320nm。结果马兜铃酸A在0.1092～0.9828μg范围内线性良好(r=0.9999),平均回收率为96.00%,RSD为1.43%,最低检测限为0.819ng,3批新生颗粒中均未检出马兜铃酸A。结论该方法简便,专属性强,灵敏度高,可用于新生颗粒中马兜铃酸A的限量检查。
Objective To establish a method for the limit detection of aristoloehic acid A in Xinsheng Granula. Methods Aristolochic Acid A limit content was detected by HPLC. The analytical column was Phenomenex Luna C18 （2） （4. 6 mm× 250 mm, 5 μm）, and the mobile phase consisted of methanol - 3.3 % acetic acid （75 ： 25）. Flow rate was 1.0 ml/min and column temperature was set at 25 ℃. The detection wavelength was at 320 nm. Results The calibration curve was linear in the range of 0. 109 2 -0. 982 8 μg （ r = 0. 999 9）. The average recovery was 96.00 % with RSD being 1.43 % , and the minimum limit of detection was 0. 819 ng. In 3 batches of Xinsheng Granules, aristolochie acid A was undetectable. Conclusion The method is simple, specific and sensitive, and it can be used for the limit detection of aristolochic acid A in Xinsheng Granules.
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2010年第1期67-69,共3页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
广东省科技厅重点课题(2005A30101017)
