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作 者:孙雨菡 许子艺 廖峻 张翮 樊莉 鲁莹 SUN Yuhan;XU Ziyi;LIAO Jun;ZHANG He;FAN Li;LU Ying(Department of Pharmaceutical,School of Pharmacy,Naval Medical University,Shanghai 200433,China;School of Medicine,Shanghai University,Shanghai 200444,China)
机构地区:[1]海军军医大学药学系药剂学教研室,上海200433 [2]上海大学医学院,上海200444
出 处:《药学实践与服务》2024年第3期127-130,共4页Journal of Pharmaceutical Practice and Service
摘 要:目的建立同时测定盐酸阿霉素(DOX·HCl)与氯尼达明(LND)含量的测定方法。方法采用HPLC法,色谱柱为Agilent 5 HC-C_(18)(2)(4.6 mm×250 mm,5μm),流动相为甲醇-0.1%TFA水溶液,梯度洗脱,甲醇比例随时间变化为:0~3 min,65%甲醇;3~7 min,65%→90%甲醇;7~13 min,90%甲醇;13~15 min,90%→65%甲醇;15~20 min、65%甲醇。采集时间20 min,平衡时间3 min,紫外检测波长205 nm及253 nm,流速1.0 ml/min,柱温35℃,进样量:10μl。结果该方法专属性好,盐酸阿霉素在1~40μg/ml的浓度范围内线性良好,氯尼达明在6~240μg/ml的浓度范围内线性良好。该方法之下,两种化合物的精密度、稳定性、回收率均符合要求。结论建立了同时检测盐酸阿霉素与氯尼达明含量的液相分析方法,该方法专属性强,准确可靠。Objective To establish a method for the simultaneous determination of DOX·HCl and LND.Methods HPLC was performed on Agilent 5 HC-C_(18)(2)(4.6 mm×250 mm,5μm)column.The mobile phase was methanol-0.1%TFA aqueous solution,and the gradient elution procedure were:0 to 3 min,65%methanol;3 to 7 min,65%→90%methanol;7 to 13 min,90%methanol;13 to 15 min,90%→65%methanol;15 to 20 min,65%methanol.The collection time was 20 min,the balance time was 3 min,the UV detection wavelengths were 205 nm and 253 nm.The flow rate was 1.0 ml/min and the column temperature was 35℃.The amount of inlet was 10μl.Results The method was highly specific,and both DOX·HCl and LND exhibited good linearity in the concentration range of 1-40μg/ml and 6-240μg/ml,respectively.The two compounds’precision,stability,and recovery satisfied the requirements of the method.Conclusion This study established a HPLC method that was suitable for the simultaneous detection of DOX·HCl and LND.This method’s high level of specificity,accuracy,and reliability.
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