Determination of Residual Organic Solvents in Imported Lidocaine Patches by GC / 中国药师

ABSTRACT

Objective:To establish a GC method for the determination of residual organic solvents in lidocaine patches. Methods:GC was carried out on a DB-WAX capillary column (30 m × 0. 25 mm, 0. 5 μm). The detector was FID and the carrier gas was He. The initial temperature was 50℃, maintained for 8 min, and then raised to 250℃ with a rate of 50℃ per min. The inlet temperature and the detector temperature were 280℃. The separation was 50 ∶1. Results:The linear range of acetone, ethyl acetate and methanol was 15. 0-600. 0 μg·ml-1. The average recovery was 97. 4% (RSD =3. 2%, n=9), 95. 6% (RSD=1. 9%, n=9) and 112. 0%(RSD =4. 5%, n=9), respectively. Conclusion:The method is simple and accurate,which can be used for the determination of re-sidual organic solvents in lidocaine patches.