摘要
采用Diamonsil C18柱（200mm×4．6mm，5μm），以0．1mol／L磷酸二氢钾（pH值7．04-0．05）-乙腈（40：60）为流动相，流速为1．0mL·min^-1，检测波长为248nm，柱温：室温。建立高效液相色谱法测定注射用盐酸氨溴索中盐酸氨溴索的含量及有关物质。盐酸氨溴索的线性范围为20-100 μg·mL^-1，相关系数r=0．9997；平均回收率为99．90％（n=9）。该方法简便、准确、专属，可用于注射用盐酸氨溴索的含量及有关物质的测定。
A HPLC method was established for the determination of ambroxol hydrochloride and its related substances in ambroxol hydrochloride for injection. A Diamonsil C18 column（200 mm ×4.6 mm,5 μm）was used . The mobile phase was 0. 1moL/L phosphate buffer （pH 7.0 ± 0.05） -acetonitrile （40：60）. The detection wavelength was 248 nm and flow rate was 1.0 mL · min ^- 1. Column temperature was room temperature. The calibration curve of ambroxol hydrochloride was linear between 20 - 100 μg · mL^- 1 （ r = 0.999 7 ）. An average recovery of 99.90% was obtained （ n = 9）. The method was simple, accurate,specific and was suitable for the determination of ambroxol hydrochloride and its related substances in ambroxol hydrochloride for injection.
出处
《化工时刊》
CAS
2008年第4期40-42,共3页
Chemical Industry Times
