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目的:建立高效液相色谱法测定氯波必利片剂的含量及有关物质。方法:采用Cosmosil Cl8色谱柱(4.6mm×250mm,5μm);流动相:以甲醇-水(60∶40,含20mmol·L-1的醋酸-醋酸钠溶液,pH=4.5);流速:1.0mL·min-1;柱温:25℃;检测波长:274nm。结果:在所选定的液相色谱条件下,有关物质与主药分离良好,氯波必利在10～200μg·mL-1范围内,线性关系良好,检出灵敏度为1.0ng。结论:方法简便灵敏,结果准确可靠,可用于氯波必利片剂含量的测定及其杂质检查。
Objective: To establish a method for the determination of chloropiper pylori content and its related substances by high performance liquid chromatography. Methods: Cosmosil Cl8 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase consisted of methanol-water (60:40, containing 20 mmol·L -1 acetic acid-sodium acetate solution, pH = 4.5) Min-1; column temperature: 25 ° C; detection wavelength: 274 nm. Results: Under the selected liquid chromatographic conditions, the related substances were separated from the main drug. The linearity of clopidogrel in the range of 10 ~ 200μg · mL-1 was good, and the detection sensitivity was 1.0ng. Conclusion: The method is simple and sensitive, the results are accurate and reliable. It can be used to determine the content of chloropiper in tablets and its impurities.