Determination of residual solvents in docetaxel by headspace gas chromatography

Abstract

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 μm 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 × 10−4; acetone = −1.49 + 7.07 × 10−5; tetrahydrofuran, A = −1.01 + 5.05 × 10−5; ethyl acetate, A = −2.87 + 1.08 × 10−4; methanol, A = 1.33 + 7.73 × 10−5; isopropanol = −2.07 + 1.60 × 10−4; dichloromethane, A = −3.93 + 3.06 × 10−4; toluene = −0.62 + 1.78 × 10−5; pyridine, A = −4.87 + 3.28 × 10−4.

Keywords

• Gas chromatography
• Docetaxel
• Residual solvents
• Headspace