HPLC法同时测定氨酚异丙嗪注射液中对乙酰氨基酚与盐酸异丙嗪的含量  

Simultaneous Assay of Compoud Paracetamol and Promethazine Hydrochloride Injection by HPLC

作　　者：蔡涛 

机构地区：[1]山东省潍坊市食品药品检验所,潍坊261205

出　　处：《中国药品标准》2012年第6期441-442,461,共3页Drug Standards of China

摘　　要：目的:建立HPLC法测定氨酚异丙嗪注射液中对乙酰氨基酚与盐酸异丙嗪的含量。方法:采用Aglient XDB-C18(4.6 mm×250 mm,5μm)色谱柱,流动相为甲醇-水(用冰醋酸调pH至2.3)(50∶50);检测波长254 nm。结果:对乙酰氨基酚与盐酸异丙嗪的线性范围分别为15.0～90.0 mg.L-1(r=0.999 9)和1.00～6.00 mg.L-1(r=0.999 9),两者的平均回收率分别为99.8%与100.6%,RSD分别为0.16%与0.76%。结论:本方法方便、快速、准确,可用于该制剂的质量控制。Objective： An HPLC method was established for determination of Compoud Paracetamol and Promethazine Hydrochloride Injection. Methods： Agilent XDB-C18 （4. 6 mm×250 mm, 5 um）column was used. The mobile phase was methanol-water （adjusted to pH 2. 3 with Acetic acid） （50： 50） , the UV detection wavelength was 254 nm. Results： For paracetamol and promethazine hydrochloride there was a good linear relation in the concentration range of 15.0-90. 0 mg · L-1 （r =0. 999 9） and 1.00-6. 00 mg· L-1 （r = 0. 999 9）. The average recovery were 99. 8% （n = 6） and 100. 6% （n = 6）. RSD were 0. 16% and 0. 76%. Conclusion： This method is simple, sensitive, accurate and can be used for the quality control of the preparation.

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

分 类 号：R921.2[医药卫生—药学]