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高效液相色谱法同时测定八味石灰华丸中2种成分含量

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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,5 μm),流动相为0.1%磷酸水溶液-甲醇(梯度洗脱),流速为1.0mL/min,检测波长为253 nm(EA)、403 nm(HYSA),柱温为35℃,进样量为10 μL.结果 EA、HYSA质量浓度分别在0.73~14.52 μg/mL及3.97~79.45 μg/mL范围内与峰面积线性关系良好(r=0.999 8、1.0000,n=7);检测限分别为0.29 μg/mL及1.59 μg/mL,定量限分别为0.58 μg/mL及3.18 μg/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.
Simultaneous Determination of Two Components in Bawei Shihuihua Pills by HPLC
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,5 μm),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 10 μL.Results The linear ranges of EA and HYSA were 0.73-14.52 μg/mL,3.97-79.45 μg/mL(r=0.999 8,1.000 0,n=7)respectively.The limits of detection of EA and HYSA were 0.29 μg/mL,1.59 μg/mL,the limits of quantification were 0.58 μg/mL,3.18 μg/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.

Tibetan medicineBawei Shihuihua Pillsellagic acidhydroxysafflor yellow AHPLCcontent determination

蔡缘缘、谢和兵、尼玛次仁、白玛旦增、袁志兵

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安徽中医药大学药学院,安徽 合肥 230012

江苏省南通市海门长三角药物高等研究院,江苏南通 226133

江苏神猴医药研究有限公司,江苏 南通 226133

西藏神猴药业有限责任公司,西藏 日喀则 857000

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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

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(24)