摘要
目的建立测定阿立哌唑有关物质的反相高效液相色谱法。方法采用Agilent ZORBAX SB-C18(150 mm×4.6 mm,5μm)色谱柱,以乙腈-0.05%三氟乙酸(10∶90,V/V)为流动相A,以乙腈-0.05%三氟乙酸(90∶10,V/V)为流动相B,梯度洗脱,流速为1.2 mL·min^(-1),检测波长为254 nm,柱温为30℃。结果阿立哌唑与7个已知杂质A~G色谱峰之间的分离度良好,各特定杂质在0.2~0.6μg·mL^(-1)内与峰面积线性关系良好(r^(2)≥0.999),定量限在0.019~0.078μg·mL^(-1),加样回收率均在90%~108%(RSD<10%,n=3)。除杂质E外,其他杂质的校正因子均在0.9~1.1,阿立哌唑在室温放置48 h稳定。结论本方法可用于阿立哌唑中有关物质的质量控制。
Objective To determine related substances in aripiprazole by reversed-phase high performance liquid chromatographic(RP-HPLC).Methods Agilent ZORBAX SB-C18(150 mm×4.6 mm,5μm)was used with gradient elution.Acetonitrile-water containing 0.05%trifluoroacetic acid(10∶90,V/V)was used as the mobile phase A and acetonitrile-water containing 0.05%trifluoroacetic acid(90∶10,V/V)as the mobile phase B.The flow rate was 1.2 mL·min^(-1).The detection wavelength was 254 nm,and the column temperature was 30℃.Results Aripiprazole and 7 impurities were well separated.The linearity was at 0.2-0.6μg·mL^(-1)(r^(2)≥0.999),and the limit of quantitation was at 0.019-0.078μg·mL^(-1).The recovery was at 90%-108%(RSD<10%,n=3).Except impurity E,the correction factor of other impurities was all within 0.9-1.1.Aripiprazole was stable at room temperature for 48 h.Conclusion The established method can determine the related substances in aripiprazole,and can be used for its quality control.
作者
尹霞
陈斌
王燕清
徐朋
陈渺丽
徐慧娟
吕林艳
顾玲玲
YIN Xia;CHEN Bin;WANG Yan-qing;XU Peng;CHEN Miao-li;XU Hui-juan;LYU Lin-yan;GU Ling-ling(Livzon Pharmaceutical Group Co.Ltd.,Zhuhai Guangdong 519000)
出处
《中南药学》
CAS
2021年第6期1189-1194,共6页
Central South Pharmacy
基金
2017年国家重大新药创制专项(No.2017ZX09201004-018)
广东省“珠江人才计划”引进第六批创新创业团队(No.2016ZT06Y229)
2016年度珠海市引进创新创业团队(No.ZH01110405160002PWC)。
