氨苄青霉素钠中有机溶媒残留量的测定与考察

Determination of Residual Organic Solvents in Ampicillin Sodium

本文用气相色谱法考察测定了全国７个生产厂家２２个批号的氨苄青霉素钠的有机溶媒残留量。色谱条件为１０％的聚乙二醇（ＰＥＧ）—１００００和３．５％—缩二甘油（ＤＧ）混合玻璃色谱柱，柱温６５℃，ＦＩＤ检测器，以正丙醇为内标。测定结果，残留溶媒及残留量主要有异丙醇０．０１９％～０．４１０％，二氯甲烷０．０２５％～０．０５１％，丙酮０．００３％～０．００６％。

By using gas chromatography residual organic solvents were determined in 22 batch numbers of ampicillin sodium produced by 7 pharmaceutical factories of our country. The chromatographic condition was glass column packed with 10% of polyethylene glycol 10000 and 3. 5% of diglycerol after mixing. Column temperature was 65℃. n-propyl alcohol served as in ternal standard. FID detector was used. The results showed that the residual organic solvents contained mainly isopropyl alcohol (0. 019%～0.41%), methylene chloride (0. 025%0～0. 051%)and acetone (0. 003%～0. 006%) .