论文部分内容阅读
目的:建立高效液相色谱法测定盐酸赛庚啶片的含量及其有关物质。方法:色谱柱:资生堂CAPCELL PAK C18(250mm×4.6 mm,5μm);流动相:甲醇-0.002 5mol·L-1庚烷磺酸钠溶液(用磷酸调节p H至3.0)(60∶40);检测波长:225 nm;流速:1.0 ml·min-1;柱温:30℃;进样量:10μl。结果:盐酸赛庚啶在4.12~82.40μg·ml-1范围线性关系良好,r=1.000 0;平均加样回收率为99.2%(RSD=0.8%,n=9)。有关物质各杂质与盐酸赛庚啶主峰的分离度良好。结论:该方法操作简单、快捷、准确,可用于盐酸赛庚啶片的质量控制。
Objective: To establish a method for the determination of cyproheptadine hydrochloride tablets and its related substances by high performance liquid chromatography. Method: Column: Shiseido CAPCELL PAK C18 (250 mm × 4.6 mm, 5 μm); mobile phase: methanol -0.002 5 mol·L -1 sodium heptane sulfonate solution (adjusted pH to 3.0 with phosphoric acid) (60:40); Detection wavelength: 225 nm; Flow rate: 1.0 ml · min-1; Column temperature: 30 ℃; Injection volume: 10μl. Results: The logarithm of cyproheptadine was linear in the range of 4.12-82.40μg · ml-1, r = 1.000 0; the average recovery was 99.2% (RSD = 0.8%, n = 9). The impurities of the relevant substances and cyproheptadine hydrochloride peak separation is good. Conclusion: The method is simple, rapid and accurate and can be used for the quality control of cyproheptadine tablets.