本文選題：超高效液相色譜法　切入點：阿洛西林鈉　出處：《中國抗生素雜志》2015年03期

【摘要】：目的探索建立合適的超高效液相色譜-梯度洗脫法檢測注射用阿洛西林鈉的有關物質(zhì),采用LC-MS法對注射用阿洛西林鈉的部分有關物質(zhì)進行鑒定。方法色譜柱為ACQUITY UPLC BEH C18,2.1mm×100mm,1.7mm;流動相A為10mmol/L甲酸銨溶液(用氨水調(diào)節(jié)p H值至6.5),流動相B為8mmol/L甲酸銨溶液(乙腈/水=200/50);柱溫為40℃;檢測波長為210nm;流速為0.43m L/min。結果阿洛西林鈉主峰與其相關物質(zhì)峰分離良好,檢出雜質(zhì)數(shù)量遠多于中國藥典2010年版二部各論方法;在0.3~90μg/m L范圍內(nèi)阿洛西林呈良好的線性關系(r2=0.9999),方法的檢測限為0.1μg/m L,重復性RSD為0.61%(n=6)。結論改進的UPLC方法的色譜性能明顯優(yōu)于現(xiàn)行標準方法,且準確、簡便、靈敏,更適用于注射用阿洛西林鈉的有關物質(zhì)檢測。
[Abstract]:Objective to establish a suitable ultra-high performance liquid chromatography-gradient elution method for the determination of related substances of aloxicillin sodium for injection. LC-MS method was used to identify some related substances of aloxicillin sodium for injection. Methods the chromatographic column was ACQUITY UPLC BEH C182.1 mm 脳 100mm ~ 1.7mm, the mobile phase A was ammonium 10mmol/L formate solution (adjust pH value to 6.5) with ammonia water, and the mobile phase B was 8mmol/L ammonium formate solution (B). The column temperature is 40 鈩，

本文編號：1660303