HPLC法测定地氯雷他定有关物质
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摘要
建立了高效液相色谱法测定地氯雷他定有关物质的分析方法。采用Thermo Hypersil BDS C_(18)(4. 6×250 mm,5μm)色谱柱,以乙腈-甲醇-磷酸盐缓冲液(10∶10∶80)为流动相A,以乙腈-四氢呋喃-磷酸盐缓冲液(45∶5∶50)为流动相B,梯度洗脱;流速1. 0 mL/min检测波长为280 nm,柱温30℃,进样量为20μL。地氯雷他定与各杂质峰分离度良好。该方法简单、快速、可靠、高效,本方法能有效的测定地氯雷他定的有关物质。
A method for the determination of related substances in desloratadine by HPLC was established. A Thermo Hypersil BDS C_(18)( 4. 6×250 mm,5 μm) column was adopted. acetonitrile-methanol-phosphate buffered saline( 10∶10∶80) was applied as mobile phase A,acetonitrile-tetrahydrofuran-phosphate buffered saline( 45∶5∶55) was applied as mobile phase B. The flow rate was 1. 0 mL/min. The detection wavelength was at 280 nm,the column temperature was 30 ℃,with 20 μL injection volume. Desloratadine and its related substances could be well separated. The method is simple,rapid,reliable and efficient,which can be applied to control the related substances of desloratadine.
A method for the determination of related substances in desloratadine by HPLC was established. A Thermo Hypersil BDS C_(18)( 4. 6×250 mm,5 μm) column was adopted. acetonitrile-methanol-phosphate buffered saline( 10∶10∶80) was applied as mobile phase A,acetonitrile-tetrahydrofuran-phosphate buffered saline( 45∶5∶55) was applied as mobile phase B. The flow rate was 1. 0 mL/min. The detection wavelength was at 280 nm,the column temperature was 30 ℃,with 20 μL injection volume. Desloratadine and its related substances could be well separated. The method is simple,rapid,reliable and efficient,which can be applied to control the related substances of desloratadine.
引文
[1]李美芳,蔡锦雄,陈承贵,等.国家评价性抽验地氯雷他定制剂质量分析[J].中国药物评价,2018,35(1):16-20.
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[5] The Unitedtates Pharmacopeial Convention. USP40-NF 35 United States Pharmacopeia[S]. 2017:3655-3656.
[6]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015.
[2]严一铭.自制和原研地氯雷他定片溶出曲线的比较和评价[J].上海医药,2018,39(17):68-71.
[3]余倩盈,刘育,姚凯,等.富马酸沃诺拉赞的合成工艺[J].中国医药工业杂志,2016,47(11):1348-1351.
[4] European Pharmacopoeia Commission. EP9. 0 European harmacopoeia[S]. 2017:2212-2213.
[5] The Unitedtates Pharmacopeial Convention. USP40-NF 35 United States Pharmacopeia[S]. 2017:3655-3656.
[6]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015.