药学研究
藥學研究
약학연구
JOURNAL OF PHARMACEUTICAL RESEARCH
2014年
10期
578-580,583
,共4页
盐酸舍曲林%高效液相色谱法%有关物质
鹽痠捨麯林%高效液相色譜法%有關物質
염산사곡림%고효액상색보법%유관물질
Sertraline hydrochloride%HPLC%Related substances
目的:建立高效液相色谱法检测盐酸舍曲林片中有关物质的方法。方法采用 Waters Symmetry C18色谱柱,以含有磷酸、磷酸二氢钾溶液和乙腈的不同比例的混合液为流动相进行梯度洗脱,流速为1.0 mL·min -1,检测波长为210 nm,柱温为25℃,进样量为20μL。结果有关物质与盐酸舍曲林主成分色谱峰分离良好。结论该方法操作简便、重复性好、专属性强,可作为盐酸舍曲林片质量控制方法。
目的:建立高效液相色譜法檢測鹽痠捨麯林片中有關物質的方法。方法採用 Waters Symmetry C18色譜柱,以含有燐痠、燐痠二氫鉀溶液和乙腈的不同比例的混閤液為流動相進行梯度洗脫,流速為1.0 mL·min -1,檢測波長為210 nm,柱溫為25℃,進樣量為20μL。結果有關物質與鹽痠捨麯林主成分色譜峰分離良好。結論該方法操作簡便、重複性好、專屬性彊,可作為鹽痠捨麯林片質量控製方法。
목적:건립고효액상색보법검측염산사곡림편중유관물질적방법。방법채용 Waters Symmetry C18색보주,이함유린산、린산이경갑용액화을정적불동비례적혼합액위류동상진행제도세탈,류속위1.0 mL·min -1,검측파장위210 nm,주온위25℃,진양량위20μL。결과유관물질여염산사곡림주성분색보봉분리량호。결론해방법조작간편、중복성호、전속성강,가작위염산사곡림편질량공제방법。
Objective To establish an HPLC method for the determination of the related substances of Sertraline Hydrochloride Tablets. Methods A gradient elution was carried out on a Waters Symmetry C18 column with mixture of phosphoric acid and potassium dihydrogen phosphate solution and acetonitrile as mobile phase,and the flow rate was 1. 0 mL ·min - 1 . The detection wavelength was 210 nm,the column temperature was 25 ℃,and the injection volume was 20 μL. Results The relevant substances were well separated from the chief agent. Conclusion The method was simple,repeat-able and specific,and can be used for the quality control of Sertraline Hydrochloride Tablets.