摘要
盐酸哌吡酮(Pirenzepine)为一抗消化性溃疡药,其含量测定有紫外法、酸性染料直接滴定法和HPLC法。由于其合成工艺的改进,成品中引入了其他一些杂质,用上述方法测定均有干扰。本文采用与本品结构相近的安定为内标,以甲醇-三乙胺-醋酸为流动相。
A simple and sensitive method for the determination of pirenzepine in dosage form by HPLC using diazepine as internal standard without the interference of impurities was developed. The chromatographic conditions were as follows: coloumn, ODS 100×4.6mm ID 5 μm; mobile phase, methanol: triethylamine (0.1mool/L): acetic acide (50%) (90: 4: 10); detecting wavelength was 254 nm. It showed a good linearity between 6—134 μg/ml with the correlation coeffecient 0.9997. Pirenzepine was extracted with the mobile phase, and the mean recovery of it from its simulated dosage form was found to be 100.5% with CV=0.43%. Complete separation of the drug was within 7.5 min under the present conditions. This method is more accurate, rapid and simple than the UV method.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1991年第3期179-180,共2页
Journal of China Pharmaceutical University
