中国药师
中國藥師
중국약사
China Pharmacist
2015年
10期
1827-1829
,共3页
高效液相色谱法%盐酸赛庚啶片%含量%有关物质
高效液相色譜法%鹽痠賽庚啶片%含量%有關物質
고효액상색보법%염산새경정편%함량%유관물질
HPLC%Cyproheptadine hydrochloride tablets%Content%Related substances
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 ( 250 mm ×4.6 mm, 5 μm);流动相:甲醇-0.002 5mol·L-1庚烷磺酸钠溶液(用磷酸调节pH至3.0)(60: 40);检测波长:225 nm;流速:1. 0 ml·min-1;柱温:30℃;进样量:10 μl. 结果:盐酸赛庚啶在4. 12~82. 40 μg·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.
目的:建立高效液相色譜法測定鹽痠賽庚啶片的含量及其有關物質. 方法:色譜柱:資生堂CAPCELL PAK C18 ( 250 mm ×4.6 mm, 5 μm);流動相:甲醇-0.002 5mol·L-1庚烷磺痠鈉溶液(用燐痠調節pH至3.0)(60: 40);檢測波長:225 nm;流速:1. 0 ml·min-1;柱溫:30℃;進樣量:10 μl. 結果:鹽痠賽庚啶在4. 12~82. 40 μg·ml-1範圍線性關繫良好, r=1. 000 0;平均加樣迴收率為99. 2%(RSD=0. 8%,n=9). 有關物質各雜質與鹽痠賽庚啶主峰的分離度良好. 結論: 該方法操作簡單、快捷、準確,可用于鹽痠賽庚啶片的質量控製.
목적:건립고효액상색보법측정염산새경정편적함량급기유관물질. 방법:색보주:자생당CAPCELL PAK C18 ( 250 mm ×4.6 mm, 5 μm);류동상:갑순-0.002 5mol·L-1경완광산납용액(용린산조절pH지3.0)(60: 40);검측파장:225 nm;류속:1. 0 ml·min-1;주온:30℃;진양량:10 μl. 결과:염산새경정재4. 12~82. 40 μg·ml-1범위선성관계량호, r=1. 000 0;평균가양회수솔위99. 2%(RSD=0. 8%,n=9). 유관물질각잡질여염산새경정주봉적분리도량호. 결론: 해방법조작간단、쾌첩、준학,가용우염산새경정편적질량공제.
Objective:To establish a determination method for the content of cyproheptadine hydyochloride 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, 5μm) column with methanol-0. 002 5mol·L-1 sodium heptanesulfonate (adjusting pH to 3 with phosphoric acid)(60: 40) as the mo-bile 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.
