高效液相色谱测定复方丹参片中丹参素钠的含量  

Determination of Sodium Danshensu in Comound Danshen Tablets by HPLC

作　　者：郭文婷 GUO Wenting(Kunming Institute for Food and Drug Control,Yunnan Kunming 650032,China)

机构地区：[1]昆明市食品药品检验所,云南昆明650032

出　　处：《广州化工》2024年第19期123-125,共3页GuangZhou Chemical Industry

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.

关 键 词：高效液相色谱法 复方丹参片 丹参素钠 含量测定 

分 类 号：R284[医药卫生—中药学]