摘要
目的建立顶空气相色谱法测定拉米夫定中有机溶剂残留量的方法。方法色谱柱为HP-5毛细管柱（5％ phenyl methyl siloxane，30m×320μm），柱温采取程序升温，检测器温度为200℃，载气为氮气，流速7．8mL·min^-1，分流比5：1。结果四种残留溶剂在8min内能很好地分离；目内精密度〈8．3％；最低检测限为0．4～4．0μg·mL^-1.供试样品中残留有机溶剂含量符合药典规定。结论该方法可用于拉米夫定中有机溶剂残留量的测定。
OBJECTIVE To develop a method for detecting the residual solvents in lamivudine, METHODS The determination was performed on HP-5 capillary column （5% phenyl methyl siloxane,30 m × 320 μm）, the column was subjected to temperature programming, the detector temperature was 200 ℃, the carrier gas was nitrogen, the flow rate was 7.8 mL · min^-1 and the split ratio was 5： 1. RESULTS All the four residual solvents were well separated in 8 minutes,the intra-day variability were 〈 8.3% ,the limits of detection were 0.4 - 4.0 μg · mL^-1. The sample met the requirements of this test. CONCLUSION The method can be used to determine the residual solvents in lamivudine.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2008年第4期325-327,共3页
Chinese Journal of Modern Applied Pharmacy
关键词
拉米夫定
顶空气相色谱法
有机溶剂
残留量
lamivudine
headspace gas chromatography
organic solvents
residual volume
