加校正因子的主成分自身对照法测定复方奥美拉唑咀嚼片中有关物质的含量

HPLC Method with Correction Factor for Determination of Content of Related Substances in Compound Omeprazole Chewable Tablet

摘要:

目的: 建立加校正因子的主成分自身对照法测定复方奥美拉唑咀嚼片中有关物质的含量。 方法: Agilent XDB C₈色谱柱(4.6 mm×150 mm,5 μm),流动相0.01 mol·L^-1磷酸氢二钠溶液(用磷酸调节pH至7.6)-乙腈(75:25);流速1.0 mL·min^-1,检测波长280 nm,柱温35℃,进样量20 μL。测定奥美拉唑和杂质A,B,C,D,E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,E的相对保留时间分别为0.3,0.9,3.4,0.8,0.4,校正因子分别为1.45,0.66,1.21,1.39,0.80。3批样品中杂质D的含量均为0.023%,其他杂质均低于检测限。 结论: 方法简便快速,可准确测定复方奥美拉唑咀嚼片中有关物质的含量。

Abstract:

Objective: The self contrast and correction factor method was established to determine the content of the related substances in Compound Omeprazole Chewable Tablet. Method: Chromatography was carried out by reversed-phase technique on an Agilent XDB C₈ column (4.6 mm×150 mm, 5 μm) with a mobile phase composed of 0.01 mol·L^-1 disodium hydrogen phosphate (adjusted to pH 7.6 with phosphate 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, E and omeprazole. The relative retention time was used to determine the position of impurities. Result: The relative retention time between impurity A, B, C, D, E and Omeprazole was 0.3, 0.9, 3.4, 0.8 and 0.4, respectively. The correction factor of impurity A, B, C, D, E was 1.45, 0.66, 1.21, 1.39 and 0.80, respectively. The content of impurity D was 0.023% in three batches of samples. Other impurities weren't detected. Conclusion: The method was simple, efficient and accurate for analyzing the related substances in Compound Omeprazole Chewable Tablet.