[關(guān)鍵詞]
[摘要]
目的 采用HPLC 法測(cè)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(dòng)相,體積流量為1.0 mL/min,檢測(cè)波長(zhǎng)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(cè)定鹽酸氨溴索注 射液中的有關(guān)物質(zhì)方法簡(jiǎn)便、準(zhǔn)確、專屬性強(qiáng)。
[Key word]
[Abstract]
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.
[中圖分類號(hào)]
[基金項(xiàng)目]
“十二五”重大新藥創(chuàng)制科技重大專項(xiàng)項(xiàng)目(2011ZX09201-101-19);國(guó)家重點(diǎn)基礎(chǔ)研究發(fā)展計(jì)劃項(xiàng)目(2010CB735602)