HPLC梯度洗脱法测定对乙酰氨基酚异丙嗪注射液中的主药及对氨基酚  

Determination of main ingredients and 4-aminopheol paracetamol in Promethazine Hydrochloride injection by HPLC

作　　者：郭志渊 傅萍[1] 谢华[1] 

机构地区：[1]四川省食品药品检验所,四川成都610041

出　　处：《华西药学杂志》2010年第3期326-328,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法同时测定对乙酰氨基酚异丙嗪注射液中的对氨基酚、对乙酰氨基酚和盐酸异丙嗪。方法采用Phenomenex C18柱(200mm×4.6mm、5μm),流动相为0.05mol·L-1醋酸铵(A)-甲醇(B),梯度洗脱为0(85%A)→10min(85%A)→11min(20%A)→30min(20%A)→31min(85%A),二极管阵列检测,对氨基酚的测定波长为232nm、对乙酰氨基酚、盐酸异丙嗪的为253nm。结果对氨基酚、对乙酰氨基酚和盐酸异丙嗪分离良好,三者的线性范围分别为5.2～104.6ng、0.23～4.67μg、0.26～5.10μg;r均为0.9999;平均回收率均为100.0%、100.4%、100.9%;RSD分别为1.3%、0.3%、0.8%(n=9)。结论所用方法结果准确,重复性良好,简便可行。OBJECTIVE To establish an HPLC method to determine paracetamol and promethazine hydrochloride in Paracetamol and Promethazine Hydrochloride injection simultaneously.METHODS Phenomenex C18 column（200 mm × 4.6 mm,5μm） was used.The mobile phase was 0.05 mol·L-1 ammonium acetate（A）-methanol（B） with gradient elution[0（85% A）→10 min（85% A）→11 min（20% A）→30 min（20% A）→31 min（85% A）].Paracetamol and promethazine hydrochloride were determined by dual wavelength in a diode array.4-Aminophenol was detected at 232 nm and paracetamol and promethazine hydrochloride were detected at 253 nm.RESULTS The resolution between 4-aminophenol,paracetamol and promethazine hydrochloride was satisfactory.The calibration curves were linear in the range of 5.2-104.6 ng for 4-aminophenol（r = 0.9999）,0.23-4.67 μg for paracetamol（r = 0.9999）,0.26-5.10 μg for promethazine hydrochloride（r = 0.9999）,respectively.The average recovery were 100.0%,100.4%,100.9% for three above mentioned components respectively with RSD of 1.3%,0.3%,0.8%（n = 9）.CONCLUSION The method is accurate,simple and precise.

关 键 词：高效液相色谱法 对乙酰氨基酚异丙嗪注射液 对氨基酚 对乙酰氨基酚 盐酸异丙嗪 

分 类 号：R917[医药卫生—药物分析学]