中国药业
中國藥業
중국약업
China Pharmaceuticals
2015年
21期
123-125
,共3页
注射用己酮可可碱%有关物质%高效液相色谱法
註射用己酮可可堿%有關物質%高效液相色譜法
주사용기동가가감%유관물질%고효액상색보법
Pentoxifylline for Injection%related substances%HPLC
目的 建立测定注射用己酮可可碱中有关物质的高效液相色谱(HPLC)法.方法 色谱柱为Agilent Zorbax Eclipse plus C8柱(250 mm × 4. 6 mm,5μm),流动相A为甲醇-0. 544%磷酸二氢钾溶液(3:7),流动相B为甲醇-0. 544%磷酸二氢钾溶液(7:3)梯度洗脱,流速为1. 0 mL/min,,检测波长为272 nm.结果 己酮可可碱与各杂质分离良好,与可可碱、茶碱、咖啡因在质量浓度0. 4~5. 0μg/mL范围内与峰面积呈良好线性关系,定量限分别为8. 5,11. 1,28. 8,12. 6 ng.结论 该法专属性强、灵敏、准确,可用于注射用己酮可可碱有关物质的测定.
目的 建立測定註射用己酮可可堿中有關物質的高效液相色譜(HPLC)法.方法 色譜柱為Agilent Zorbax Eclipse plus C8柱(250 mm × 4. 6 mm,5μm),流動相A為甲醇-0. 544%燐痠二氫鉀溶液(3:7),流動相B為甲醇-0. 544%燐痠二氫鉀溶液(7:3)梯度洗脫,流速為1. 0 mL/min,,檢測波長為272 nm.結果 己酮可可堿與各雜質分離良好,與可可堿、茶堿、咖啡因在質量濃度0. 4~5. 0μg/mL範圍內與峰麵積呈良好線性關繫,定量限分彆為8. 5,11. 1,28. 8,12. 6 ng.結論 該法專屬性彊、靈敏、準確,可用于註射用己酮可可堿有關物質的測定.
목적 건립측정주사용기동가가감중유관물질적고효액상색보(HPLC)법.방법 색보주위Agilent Zorbax Eclipse plus C8주(250 mm × 4. 6 mm,5μm),류동상A위갑순-0. 544%린산이경갑용액(3:7),류동상B위갑순-0. 544%린산이경갑용액(7:3)제도세탈,류속위1. 0 mL/min,,검측파장위272 nm.결과 기동가가감여각잡질분리량호,여가가감、다감、가배인재질량농도0. 4~5. 0μg/mL범위내여봉면적정량호선성관계,정량한분별위8. 5,11. 1,28. 8,12. 6 ng.결론 해법전속성강、령민、준학,가용우주사용기동가가감유관물질적측정.
Objective To establish an HPLC gradient elution method for the determination of related substances in pentoxifylline for in-jection. Methods Agilent Zorbax Eclipse plus C8 column ( 250 mm × 4. 6 mm, 5 μm ) was used, the methanol-0. 544% solution of potassium dihydrogen phosphate ( 3:7 ) as mobile phase A, and a mixture of methanol-0. 544% solution of potassium dihydrogen phos-phate-( 7:3 ) as mobile phase B. The detection wavelength was 272 nm and the flow rate 1. 0 mL/min for the gradient elute. Results Pentoxifylline and its related substances can be separated effectively by this method. The concentration-response relationship was linear over the range of 0. 4-5. 0 μg/mL and the limit of detection were 8. 5, 11. 1, 28. 8, 12. 6 ng. Conclusion The HPLC method is spe-cific, accurate and sensitive which may be used for the inspection of related substances in pentoxifylline for injection.
