摘要
为建立质控指标,有效控制药品质量,建立测定复方丹参片中丹参素钠的含量的高效液相色谱法。采用Agilent zorbax SB-C_(18)色谱柱(4.6 mm×150 mm,5μm),以甲醇-0.05%磷酸溶液(15∶85)为流动相,流速1.0 mL/min,检测波长280 nm,柱温30℃。丹参素钠在4.979~99.590μg/mL范围内与其峰面积值呈良好的线性关系(r=0.9997),平均回收率为100.36%,RSD为1.7%。24 h内供试品溶液稳定性良好,RSD为0.37%。本方法简便易行,准确可靠,可用于复方丹参片的质量控制。
A HPLC method was established for the determination of Danshensu sodium in compound Danshen tablets.Agilent zorbax SB-C_(18) column(4.6 mm×150 mm,5μm)was used,methanol-0.05%phosphoric acid solution(15∶85)was used as mobile phase,flow rate was 1.0 mL/min,detection wavelength was 280 nm,and column temperature was 30℃.The calibration curve showed a good linear correlation within the concentration range of 4.979 to 99.590μg/mL(r=0.9997).The average recovery was 100.36%with RSD of 1.7%(n=6).The test solution had good stability within 24 h with RSD of 0.37%.The developed method is accurate with high repeatability,which is helpful for the determination of Sodium Danshensu in compound Danshen tablets.
作者
郭文婷
GUO Wenting(Kunming Institute for Food and Drug Control,Yunnan Kunming 650032,China)
出处
《广州化工》
CAS
2024年第19期123-125,共3页
GuangZhou Chemical Industry
