目的 采用HPLC 法測定鹽酸氨溴索注射液中的有關(guān)物質(zhì)。方法 采用Agela Venusil MP C18 柱（250 mm×4.6 mm， 5 μm），以磷酸氫二銨緩沖液（pH 4.0）–甲醇（40∶60）為流動相，體積流量為1.0 mL/min，檢測波長為250 nm，柱溫： 30 ℃。結(jié)果 鹽酸氨溴索和反式-4-[6,8-二溴-1,4-二氫喹唑啉-3(2H)]環(huán)己醇的最小檢出限分別為15、30 ng；雜質(zhì)的線性范 圍為0.72～1.68 μg/mL（r=0.999 6），加樣平均回收率為101.32%，RSD 為0.92%（n=9）。結(jié)論 該方法測定鹽酸氨溴索注 射液中的有關(guān)物質(zhì)方法簡便、準確、專屬性強。

Objective To develop a method for the determination of related substances in Ambroxol Hydrochloride Injection. Methods The analysis was performed on an Agela Venusil MP C18 column (250 mm×4.6 mm, 5 μm). The mobile phase was ammonium dibasic phosphate buffer (pH 4.0)-methanol (40:60) with flow rate at 1.0 mL/min. The detection wavelength was 250 nm and column temperature was 30 ℃. Results The minimum detection limit of ambroxol hydrochloride and trans-4-[[(2-amino-3,5-dibromophenyl) methyl] amino]-cyclohexanol was 15 ng and 30 ng, respectively. The calibration curve of impurity was linear in the range of 0.72—1.68 μg/mL (r=0.999 6); An average recovery rate of 101.32% was obtained with RSD 0.92% (n=9). Conclusion This method is simple, accurate and with good specificity and could be used to determine the related substances in Ambroxol Hydrochloride Injection.

“十二五”重大新藥創(chuàng)制科技重大專項項目（2011ZX09201-101-19）；國家重點基礎(chǔ)研究發(fā)展計劃項目（2010CB735602）