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HPLC测定罗氟司特的有关物质 被引量:5

Assay of Roflumilast and the Determination of Its Related Substances by HPLC
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摘要 建立高效液相色谱法测定罗氟司特的有关物质。采用Shimadzu VP-ODS C18色谱柱,甲醇-醋酸铵缓冲液(pH 4.5)(60∶40)为流动相,检测波长为245nm,柱温25℃。罗氟司特检出限为9.3×10-10g·mL-1,主成分与其相邻杂质峰分离良好。本方法简便、准确、灵敏度高、专属性好,可用于罗氟司特有关物质的测定。 A method was established to determine the content of related substance of roflumilast. A shimadzu VP-ODS Cls column was used with methanol-ammonium acetate buffer (pH= 4. 5) (60 : 40) at column temperature of 25 C as the mobile phase. The detection wavelength was set at 245nm. The detection limit for roflumilast was 9.3 × 10^-10g · mL^-1 Good resolution for roflumilast and related, substances was obtained. The method is simple, accurate, reliable and sensitive for the quality control of roflumilast.
作者 郑曦孜
出处 《光谱实验室》 CAS 2013年第6期3122-3126,共5页 Chinese Journal of Spectroscopy Laboratory
关键词 高效液相色谱法 罗氟司特 有关物质 HPLC Roflumilast Related Substance
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