中国药房2011，Vol.22Issue(17)：1607-1608,2.
顶空气相色谱法测定洛伐他汀原料药中的有机溶剂残留量
Determination of Residual Organic Solvents in Lovastatin by Headspace Gas Chromatography
摘要
Abstract
OBJECTIVE: To establish a method for the content determination of residual organic solvents in lovastatin, i.e.alcohol, acetone, ethyl acetate and methylbenzene.METHODS: Headspace GC was adopted.The determination were separated on DB-624 capillary column using temperature programming.FID was used as detector with a temperature of 280 ℃, and the inlet temperature was 160 ℃.RESULTS: The linear ranges of alcohol, acetone, ethyl acetate and methylbenzene were 10.0～250 μg· mL-1 (r=l.000 0), 10.0～2550 μg·mL-1 (r=0.999 9), 10.0～250 μg·mL-1 (r=0.999 9), 1.78～89 μg·mL-1 (r=0.999 7), respectively.The average recoveries ranged from 97.6％ to 99.1％ with RSD of 0.9％～1.9％.The determination limits were 0.22～ 5.61 μg·mL-1.The residual levels for the 4 organic solvents in 4 batches of samples were all up to the standard stipulated in Chinese Pharmacopeia (2005 edition).CONCLUSION: The method is simple, precise, accurate and reliable.关键词
洛伐他汀/顶空气相色谱法/有机溶剂/残留量分类
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姜建国,宋更申,张西如,高燕霞..顶空气相色谱法测定洛伐他汀原料药中的有机溶剂残留量[J].中国药房,2011,22(17):1607-1608,2.
