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.
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)
出处
《黑龙江医学》
2022年第15期1854-1856,共3页
Heilongjiang Medical Journal
关键词
西咪替丁片
高效液相色谱法
有关物质
Cimetidine tablets
High performance liquid chromatography
Related substances
