Determination of Residual Organic Solvents in Mebendazole by GC

OBJECTIVE To establish a headspace gas chromatography method for determination of residual solvents in mebendazole active pharmaceutical ingredients. METHODS The samples were dissolved in DMF-H₂O(2︰1). PerkinElmer gas chromatography with headspace sampling and FID detector was selected. Agilent DB-624 capillary column was used as analytical column. External standard method was used to determine the content. RESULTS A good linear correlation of methanol, alcohol, isopropanol, trichloromethane and toluenethe were shown at the range of 18.7-224, 46.9-562, 46.9-562, 1.50-17.9, 2.81-33.8 μg·mL^-1(r>0.999), respectively. Detection limit of each components were 0.19, 0.10, 0.11, 0.18, 0.08 μg·mL^-1. Recovery range were 90.0%-110.0%. CONCLUSION With good accuracy, sensitivity and reliability, the method can be used for the determination of the residual organic solvents in mebendazole.