RP-HPLC法测定复方奥美拉唑干混悬剂的含量及有关物质

摘要

目的 建立RP-HPLC法测定复方奥美拉唑干混悬剂中奥美拉唑的含量及其有关物质.方法 采用Phenomenex Luna C18色谱柱(250 mm×4.60 mm,5 μm),流动相:甲醇-水-三乙胺-磷酸(体积比为55∶45∶0.3∶0.12),流速:1.0 mL/min,柱温:30 ℃,进样量:20 μL,含量测定的检测波长为302 nm,有关物质测定的检测波长为280 nm.结果 奥美拉唑经强制破坏主峰与杂质可得到良好的分离,浓度在0.133~30.0 mg/L范围内线性关系良好(r=0.999 7),平均回收率为99.0%(RSD=0.2%,n=9).3批样品及对照药品的含量分别为97.5%、97.6%、97.5%、92.3%,单一最大杂质分别为0.06%、0.06%、0.05%、0.15%,总杂质分别为0.11%、0.11%、0.11%、0.45%.结论 本法可用于测定复方奥美拉唑干混悬剂的含量及有关物质.%Objective To establish an RP-HPLC method for the determination of omeprazole and its related substances in compound omeprazole powder for oral suspension.Methods A Phenomenex Luna C18 column (250 mm×4.60 mm,5 μm) was used,the mobile phase consisted of methanol-water-triethylamine-phosphoric acid (V∶V∶V∶V=55∶45∶0.3∶0.12) at the rate of 1.0 mL/min,the column temperature was 30 ℃ and the injection volume was 20 μL;the detection wavelength was 302 nm and 280 nm for the determination of the content and related substances,respectively.Results Omeprazole was completely separated from its degradation products,the linear range was 0.133~30.0 mg/L(r=0.999 7),and the average recovery was 99.0%(RSD=0.2%,n=9).The contents of 3 batches of samples and reference drug were 97.5%,97.6%,97.5% and 92.3%,respectively.The maximum single impurity was 0.06%,0.06%,0.05% and 0.15%,respectively.The total impurities were 0.11%,0.11%,0.11% and 0.45%,respectively.Conclusion The method can be used for the determination of the content and related substances in compound omeprazole powder for oral suspension.