高效液相色谱法同时测定八味石灰华丸中2种成分含量  

Simultaneous Determination of Two Components in Bawei Shihuihua Pills by HPLC

作　　者：蔡缘缘 谢和兵 尼玛次仁 白玛旦增 袁志兵 CAI Yuanyuan;XIE Hebing;NIMA Ciren;BAIMA Danzeng;YUAN Zhibing(School of Pharmacy,Anhui University of Chinese Medicine,Hefei,Anhui,China 230012;Yangtze Delta Drug Advanced Research Institute,Nantong,Jiangsu,China 226133;Jiangsu Shenhou Pharmaceutical Research Co.,Ltd.,Nantong,Jiangsu,China 226133;Tibet Shenhou Pharmaceuti-cal Co.,Ltd.,Shigatse,Xizang,China 857000)

机构地区：[1]安徽中医药大学药学院,安徽合肥230012 [2]江苏省南通市海门长三角药物高等研究院,江苏南通226133 [3]江苏神猴医药研究有限公司,江苏南通226133 [4]西藏神猴药业有限责任公司,西藏日喀则857000

出　　处：《中国药业》2024年第24期74-77,共4页China Pharmaceuticals

基　　金：国家自然科学基金[81470247];西藏自治区日喀则市区域科技协同创新专项[QYXTZX-RKZ2022-07]。

摘　　要：目的建立同时测定八味石灰华丸中鞣花酸(EA)、羟基红花黄色素A(HYSA)含量的高效液相色谱(HPLC)法。方法色谱柱为ZORBAX Eclipse Plus C18柱(250 mm×4.6 mm,5μm),流动相为0.1%磷酸水溶液-甲醇(梯度洗脱),流速为1.0 mL/min,检测波长为253 nm(EA)、403 nm(HYSA),柱温为35℃,进样量为10μL。结果EA、HYSA质量浓度分别在0.73~14.52μg/mL及3.97~79.45μg/mL范围内与峰面积线性关系良好(r=0.9998、1.0000,n=7);检测限分别为0.29μg/mL及1.59μg/mL,定量限分别为0.58μg/mL及3.18μg/mL;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为103.36%及102.57%,RSD分别为3.00%及2.75%(n=6)。结论该方法操作简便、结果准确,可用于同时测定八味石灰华丸中EA、HYSA的含量。Objective To establish a high-performance liquid chromatography(HPLC)method for simultaneous determination of ellagic acid(EA)and hydroxysafflor yellow A(HYSA)in Bawei Shihuihua Pills.Methods The chromatographic column was the ZORBAX Eclipse Plus C18 column(250 mm×4.6 mm,5μm),the mobile phase was 0.1%phosphoric acid aqueous solution-methanol(gradient elution),the flow rate was 1.0 mL/min,the detection wavelengths were 253 nm(EA)and 403 nm(HYSA),the column temperature was 35℃,and the injection volume was 10μL.Results The linear ranges of EA and HYSA were 0.73-14.52μg/mL,3.97-79.45μg/mL(r=0.9998,1.0000,n=7)respectively.The limits of detection of EA and HYSA were 0.29μg/mL,1.59μg/mL,the limits of quantification were 0.58μg/mL,3.18μg/mL respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of EA and HYSA were 103.36%,102.57%with RSDs of 3.00%,2.75%(n=6)respectively.Conclusion This method is easy and accurate,which can be used to simultaneously determine the contents of EA and HYSA in Bawei Shihuihua Pills.

关 键 词：藏药 八味石灰华丸 鞣花酸 羟基红花黄色素A 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]