现代仪器与医疗
現代儀器與醫療
현대의기여의료
Modern Instrument and Medical Treatment
2015年
1期
67-69,92
,共4页
全红娜%金松子%商国举%蒋庆峰
全紅娜%金鬆子%商國舉%蔣慶峰
전홍나%금송자%상국거%장경봉
气相色谱法%残留溶剂%顶空进样
氣相色譜法%殘留溶劑%頂空進樣
기상색보법%잔류용제%정공진양
Gas Chromatography%residual solvents%headspace injector
目的：建立YA原料药中甲醇、异丙醇、二氯甲烷、乙酸乙酯、正庚烷、甲苯、乙酸丁酯和氯苯8种残留溶剂的测定方法。方法：采用Agilent DB-624毛细管色谱柱（30 m×0.53 mm，30μm）；顶空进样法；FID检测器；程序升温：40℃维持2 min，5℃·min-1升温至80℃，维持2 min，10℃·min-1升温至200℃。选用二甲基亚砜为溶剂。结果：各溶剂分离情况良好，在各自的浓度范围内，线性关系良好，8种溶剂的平均回收率范围为96.4%～101.0%，RSD值是0.5%～2.2%。结论：该方法灵敏度高、简便、快速准确，可用于YA原料药中残留溶剂的检测。
目的：建立YA原料藥中甲醇、異丙醇、二氯甲烷、乙痠乙酯、正庚烷、甲苯、乙痠丁酯和氯苯8種殘留溶劑的測定方法。方法：採用Agilent DB-624毛細管色譜柱（30 m×0.53 mm，30μm）；頂空進樣法；FID檢測器；程序升溫：40℃維持2 min，5℃·min-1升溫至80℃，維持2 min，10℃·min-1升溫至200℃。選用二甲基亞砜為溶劑。結果：各溶劑分離情況良好，在各自的濃度範圍內，線性關繫良好，8種溶劑的平均迴收率範圍為96.4%～101.0%，RSD值是0.5%～2.2%。結論：該方法靈敏度高、簡便、快速準確，可用于YA原料藥中殘留溶劑的檢測。
목적：건립YA원료약중갑순、이병순、이록갑완、을산을지、정경완、갑분、을산정지화록분8충잔류용제적측정방법。방법：채용Agilent DB-624모세관색보주（30 m×0.53 mm，30μm）；정공진양법；FID검측기；정서승온：40℃유지2 min，5℃·min-1승온지80℃，유지2 min，10℃·min-1승온지200℃。선용이갑기아풍위용제。결과：각용제분리정황량호，재각자적농도범위내，선성관계량호，8충용제적평균회수솔범위위96.4%～101.0%，RSD치시0.5%～2.2%。결론：해방법령민도고、간편、쾌속준학，가용우YA원료약중잔류용제적검측。
Objective: To establish a method for determination of the residues of eight kinds of residual solvents in YA by gas chromatography.Methods: The eight organic solvents were separated on a Capillary Column of DB-624 (30 m×0.53 mm,30μm); Headspace injector; FID detector; Using programmable increased temperature: the column temperature is initially maintained at 40℃ for 2 min and then up to 80℃ at the rate of 5℃?min-1 for 2 min, and eventually raised to 200℃ at the rate of 10℃?min-1.Results: Each solvent was completely separated and had excellent linearity in the range of respective concentrations. The average recoveries were 96.5% to 101.0% with coefifcient of variation from 0.3% to 2.2%.Conclusion: The method is sensitive, simple, rapid and accurate, and can be used to detect the amount of residual solvents in YA.
