GC法测定可降解辅料聚L-乳酸中丙交酯残留量

Determination of lactide in the pharmaceutical excipient poly-L-lactic acid by gas chromatography

目的:建立可降解辅料聚L-乳酸中丙交酯残留量的测定方法。方法:采用气相色谱法。通过正交试验,优选供试品溶液制备和气相色谱条件参数,将优选所得方法按中国药典规定进行方法学论证。结果:供试品溶液制备用溶剂最佳配比为三氯甲烷∶乙醇=1∶4,进样口最佳温度为280℃,柱温箱最佳温度为125℃;主要方法学的各项指标均符合2010年版中国药典规定。结论:本方法可用于测定可降解辅料聚L-乳酸中丙交酯残留量,方法准确、简便。

Objective： To develop a gas chromatograph（GC） method for determination of lactide in pharmaceutical adjuvant poly-L-lactic acid（PLLA）.Methods： The sample preparation and GC condition was optimized by orthogonal test.Then the methodology was performed according to Chinese Pharmacopoeia.Results： The optimal GC condition was as follows： the primary solvent was chloroform-ethanol（1∶ 44）,an injector port temperature at 280 ℃,an oven temperature at 125 ℃.All parameters were conformed to Chinese Pharmacopoeia 2010 edition.Conclusion： The accurate and simple GC method for determination of lactide in the pharmaceutical excipient PLLA is attainable.