HPLC法测定盐酸赛庚啶片的含量及其有关物质

Determination of Content and Related Substances of Cyproheptadine Hydyochloride Tablets by HPLC

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 determination method for the content of cyproheptadine hydyoehloride tablets and the related substances in the tablets by HPLC. Methods： The assay was performed on a CAPCELL PAK C18 （Shiseido） （250 mm× 4.6 mm, 5 μm） column with methanol-0.002 5mol · L-1 sodium heptanesulfonate （ adjusting pH to 3 with phosphoric acid） （60： 40） as the mobile phase. The detection wavelength was 225 nm, the flow rate was 1.0 ml · min-1, the column temperature was 30℃ and the sample size was 10 μl. Results： Cyproheptadine hydyochloride had good linear relationship within the range of 4.12-82.40 μg · ml-1 （r = 1. 000 0 ）, and the average recovery was 99.2% （ RSD = 0.8%, n = 9 ）. The peaks of the related substances were well separated from that of cyproheptadine hydrochloride. Conclusion： The method is simple, fast and accurate, and can be used for the quality control of cyproheptadine hydyochloride tablets.