Determination of residual solvents in docetaxel by headspace gas chromatography

A simple and sensitive gas chromatographic method has been developed and validated for simultaneous determination of heptane, acetone, tetrahydrofuran, ethyl acetate, methanol, 2-propanol, dichloromethane, toluene and pyridine in docetaxel. The separation was achieved on 60 m long DB-WAXETR Polyethylene glycol column, 0.250 mm in inner diameter and 0.25 mu m in film thickness. The developed gas chromatographic method offers symmetric peak shape, good resolution and reasonable retention time for all the solvents. The limit of detection of methanol, acetone, iso-propanol, ethyl acetate, toluene, dichloromethane, tetrahydrofuran, pyridine and heptane was found to be 0.027, 0.50, 0.12, 0.070, 0.070, 0.180, 0.040, 0.170 and 0.040, respectively. The linear regression equations obtained were heptane, A = -0.62 + 1.55 x 10(-4); acetone = -1.49 + 7.07 x 10(-5); tetrahydrofuran, A = -1.01 + 5.05 x 10(-5); ethyl acetate, A = -2.87+ 1.08 x 10(-4); methanol, A = 1.33 + 7.73 x 10(-5); isopropanol = -2.07 + 1.60 x 10(-4); dichloromethane, A = -3.93 + 3.06 x 10(-4); toluene = -0.62 + 1.78 x 10(-5); pyridine, A = -4.87 + 3.28 x 10(-4). (c) 2013 Production and hosting by Elsevier B.V. on behalf of King Saud University.