目的 建立HPLC法測(cè)定加替沙星有關(guān)物質(zhì)。方法 采用HPLC法，色譜柱為Agilent HC-C₁₈（250 mm × 4.6 mm，5 μm），流動(dòng)相為三乙胺磷酸溶液 [三乙胺溶液（1→100），用磷酸調(diào)節(jié)pH值至4.3]-乙腈（87：13），檢測(cè)波長(zhǎng)為325 nm，柱溫為30 ℃。結(jié)果 加替沙星和9個(gè)已知雜質(zhì)均能達(dá)到基線分離，樣品中各雜質(zhì)及主峰的分離度和檢測(cè)靈敏度均滿足有關(guān)物質(zhì)的測(cè)定要求。結(jié)論 方法靈敏、準(zhǔn)確，專屬性強(qiáng)，可有效控制產(chǎn)品質(zhì)量。

Objective To establish a method for the determination of related substances in gatifloxacin by HPLC. Methods The separation was performed on a Agilent HC-C₁₈ column (250 mm × 4.6 mm, 5 μm). using triethylamine-phosphoric acid solution [triethylamine solution (1→100), adjusted to pH 4.3 by phosphoric acid]-acetonitrile (87:13) as mobile phase. The column temperature was 30 ℃ and detective wavelength was 225 nm. Results The resolutions between gatifloxacin and its nine known impurities could meet the requirement. The sensitivity of the method was acceptable. Conclusion The method is sensitive, accurate, and specific, and can be used for the quality control of product effectively.

全球基金結(jié)核病整合項(xiàng)目衛(wèi)生系統(tǒng)加強(qiáng)部分：藥品質(zhì)量標(biāo)準(zhǔn)提高課題（GF2012-34，GF2012-35，GF2012-36）