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高效液相色谱法测定酚酞片中的7个杂质

作者:聂忠莉1, 赵树敏1, 王晓玲2, 赵玉玲2, 张 勇2, 萧茂玲2     时间:2019-09-29 11:28      浏览:190
文章编号:1004-5422(2019)03-0256-04                                               DOI:10.3969/j.issn.1004-5422.2019.03.006


高效液相色谱法测定酚酞片中的7个杂质


聂忠莉1, 赵树敏1, 王晓玲2, 赵玉玲2, 张 勇2, 萧茂玲2
(1.成都大学 药学与生物工程学院, 四川 成都 610106; 2.成都克莱蒙医药科技有限公司, 四川 成都 610041)

摘 要: 建立高效液相色谱法测定酚酞片中的7个杂质.色谱柱采用十八烷基硅烷键合硅胶为填充剂,以含0.01 mol/L磷酸二氢钾的0.1%醋酸水溶液—乙腈(90∶10)为流动相A ,0.01 mol/L磷酸二氢钾溶液的0.1%醋酸水溶液—乙腈(30∶70)为流动相B,进行梯度洗脱;检测波长为270 nm,柱温40 ℃,流速1.0 mL/min.实验结果显示,方法简便、准确、重复性好,可为酚酞片质量标准的制定提供参考.
关键词: 酚酞片;高效液相色谱法;杂质;测定;含量
中图分类号:R927.2;O657.72          文献标志码:A


Determination of Seven Kinds of Impurities in Phenolphthalein Tablets by HPLC


NIE Zhongli1, ZHAO Shumin1, WANG Xiaoling2,ZHAO Yuling2, ZHANG Yong2, XIAO Maoling2

(1.School of Pharmacy and Bioengineering, Chengdu University, Chengdu 610106, China;

2.Chengdu Climb Pharmaceutical Technology Co., Ltd., Chengdu 610041, China)


Abstract:The paper is going to establish a HPLC method to determine seven kinds of impurities in phenolphthalein tablets.The chromatographic column adopts octadecyl silane chemically bonded silica as the filler,takes acetic acid-acetonitrile(90∶10) with 0.1 mol/L monopotassium phosphate as the mobile phase A,and takes 0.01 mol/L potassium dihydrogen phosphate solution 0.1% acetic acidacetonitrile (30∶70) as mobile phase B.Then gradient elution is carried out.The detection wavelength is 270 nm;column temperature is 40 ℃;flow rate is 1.0 mL/min.It is concluded that this method is characterized by succinctness,exactness and good reproducibility,and it offers references to the establishment of quality standard of phenolphthalein tablets.

Key words:phenolphthalein tablets;high performance liquid chromatographic method;impurities;determination;content