摘要
目的:建立加校正因子的主成分自身对照法测定奥美拉唑肠溶胶囊中有关物质的含量。方法:Agilent HC-C8色谱柱(4.6 mm×250 mm,5μm),流动相0.01 mol·L^(-1)磷酸氢二钠溶液(用磷酸调节p H至7.6)-乙腈(75∶25),流量1.0 m L·min^(-1),检测波长280 nm,柱温35℃,进样量20μL。测定奥美拉唑和杂质A,B,C,D的线性方程,以斜率计算杂质相对于奥美拉唑的校正因子,用相对保留时间确定各杂质位置。结果:奥美拉唑杂质A,B,C,D的相对保留时间分别为0.27,0.31,0.41,0.79;校正因子分别为1.20,0.58,0.57,1.04。3批样品中杂质D的含量均为0.022%,其他杂质均低于检测限。结论:该方法简便快速,可准确测定奥美拉唑肠溶胶囊中4种有关物质的含量。
Objective：To estabilishthe main component self-compare with calibration factor method to determine the contents of related substances in Omeprazole Enteric Capsules. Methods： An Agilent HC-Cs column （4.6mm×250mm,5μm） was adopted with the mobile phase composed of 0. 01 mol·L^-1 disodium hydrogen phosphate （adjusted to pH 7. 6 with phosphoric acid ） and acetonitrile in the ratio of （75：25 ） pumped at a flow-rate of 1.0 mL ·min^-1. The detection was carried out at 280 nm and a column temperature of 35 ℃. The injection volume was 20 μL. The slope of linear equation was used to determine the correction factor between impurity A, B, C, D and Omeprazole. The relative retention time was used to determine the position of impurities. Results： The relative retention time between impurity A,B,C and D Omeprazole was 0. 27,0. 31,0. 41 and 0. 79 ,respectively. The correction factor of impurity A,B,C and D was 1.20,0. 58,0. 57 and 1.04, respectively. The content of impurity D was 0. 022% in three batches of samples. Other impurities weren t detected. Conclusion： The method is simple,efficient and accurate for analyzing the related substances in Omeprazole Enteric Capsules.
出处
《中国药品标准》
CAS
2015年第6期442-446,共5页
Drug Standards of China
关键词
奥美拉唑肠溶胶囊
有关物质
加校正因子的主成分自身对照法
Omeprazole Enteric Capsules
related substances
main component self-compare with calibration factor method
