高效液相色谱法测定西咪替丁片中的有关物质和含量  

Determination of Related Substances and Content in Cimetidine Tablets by High Performance Liquid Chromatography

作　　者：刘振丽 徐丽 LIU Zhen-li;XU Li(Food and Drug Inspection,Zhumadian Food and Drug Inspection Institute,Zhumadian,Henan,463000,China)

机构地区：[1]驻马店市食品药品检验所食品药品检验科,河南驻马店463000

出　　处：《黑龙江医学》2022年第15期1854-1856,共3页Heilongjiang Medical Journal

摘　　要：目的:探讨高效液相色谱(HPLC)法测定西咪替丁片中的有关物质和含量。方法:以Kromasil C18作为色谱柱,以甲醇—水—乙腈(250∶680∶70,每1 000 mL中含0.5 mL磷酸和1.081 g己烷磺酸钠)作为流动相,检测波长为220 nm,流速1.0 m L/min,进样量调整为10μL,以室温为柱温度检测。结果:西咪替丁与有关物质分离好,其与周围的有关物质峰分离度>9。浓度范围在4.928~123.2μg/mL,线性关系良好,r=0.999 8。加样平均回收率为99.9%。测定西咪替丁检测限与定量限分别为1.035μg/mL、5.136μg/mL。结论:HPLC法检测敏感度高、专属性强、结果准确,可用于检测西咪替丁片的含量与有关物质的测定。Objective: To investigate the determination of related substances and contents in cimetidine tablets by high performance liquid chromatography(HPLC). Methods: Kromasil C18 was used as the chromatographic column, methanol-wateracetonitrile(250∶680∶70, 0.5 mL phosphoric acid and 1.081 g sodium hexanesulfonate per 1 000 mL) were used as the mobile phase, the detection wavelength was 220 nm, and the flow rate was 1.0 m L/min, the injection volume was adjusted to 10 μL, and the column temperature was detected at room temperature. Results: Cimetidine was well separated from related substances, and its peak separation degree from surrounding related substances was>9. The concentration range was 4.928~123.2 μg/mL with a good linear relationship r=0.999 8.The average recovery of the samples was 99.9%. The limit of detection and limit of quantification of cimetidine were determined to be 1.035 μg/mL and 5.136 μg/mL, respectively. Conclusion: The HPLC method has high detection sensitivity, strong specificity and accurate results, and can be used to detect the content of cimetidine tablets and the determination of related substances.

关 键 词：西咪替丁片 高效液相色谱法 有关物质 

分 类 号：R282.71[医药卫生—中药学]