摘要
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 m L/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/m L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。
Objective To establish an HPLC gradient elution method for the determination of related substances in pentoxifylline for injection. 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 phosphate-( 7∶ 3) as mobile phase B. The detection wavelength was 272 nm and the flow rate 1. 0 m L / 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 / m L and the limit of detection were 8. 5,11. 1,28. 8,12. 6 ng. Conclusion The HPLC method is specific,accurate and sensitive which may be used for the inspection of related substances in pentoxifylline for injection.
出处
《中国药业》
CAS
2015年第21期123-125,共3页
China Pharmaceuticals
