Objective:To develop an HPLC method for determination of promethazine hydrochloride and its related substances in injections.Method:Using HPLC with Diamonsil C18 column,0.05 mol·L-1 diammonium dihydrogen phosphate(adjusted to pH 3.2 with phosphoric acid)-acetonitrile (70∶30) as the mobile phase.The wavelength used for detection was 249 nm.Results:The standard curve was rectilinear in the range of 10.13-121.58 μg·mL-1 (r=0.9995).The average recovery was 100.3% (RSD=0.33%,n=6).Good separation of promethazine hydrochloride and its related substances could be achieved.The limit of detection and quantification were 0.4 ng and 1.6 ng.Conclusion:This method is simple,sensitive,selective and repetitive
1ChP(中国药典)2005.Vol Ⅱ(二部):512
2CHEN Jian(陈建),LI Yun(利云),ZHANG Jia-ming(张家明).HPLC determination of reserpine and promethazine hydrochloride in compound capsules of antihypertension(HPLC法测定复方降压胶囊中利血平及盐酸异丙嗪含量).Chin J Pharm Anal(药物分析杂志),2008,28(7):1159
3LIANG Gai-ling(梁改玲),WANG Xue-qin(王雪芹),ZHONG Ping(仲平).HPLC determination of promethazine hydrochloride in promethazine and bile tablets(高效液相色谱法测定异丙嗪胆汁片中盐酸异丙嗪的含量).Chin J Pharm Anal(药物分析杂志),2005,25(9):1129
4WANG Li-na(王丽娜),LI Yan-jie(李艳杰).Simultaneous determination of chlordiazepoxide and promethazine hydrochloride in luojijiangya tablets by HPLC(HPLC法同时测定罗己降压片中氯氮草和盐酸异丙嗪的含量).Chin Pharm Aff(中国药事),2009,23(1):60
5LIANG Gai-ling(梁改玲),WANG Xue-qin(王雪芹),ZHONG Ping(仲平).HPLC determination of promethazine hydrochloride in promethazine and bile tablets(高效液相色谱法测定异丙嗪胆汁片中盐酸异丙嗪的含量).Chin J Pharm Anal(药物分析杂志),2005,25(9):1129
6CHEN Jian(陈建), LI Yun(利云), ZHANG Jia-ming(张家明),et al.HPLC determination of reserpine and promethazine hydrochloride in compound capsules of antihypertension(HPLC法测定复方降压胶囊中利血平及盐酸异丙嗪含量).Chin J Pharm Anal(药物分析杂志),2008,28(7):1168