Abstracto

Trace level analysis of epichlorohydrin in pharmaceuticals by capillary gas chromatography with flame ionization detection

Ch.Krishnaiah, B.J.Durga Prasad, A.Raghupathi Reddy, Ramesh Kumar, K.Mukkanti

A capillary gas chromatographic method using flame ionization detection was developed and validated for the trace analysis (ppmlevel) of Epichlorohydrin in pharmaceutical drug substance and drug product. The method utilizes a capillary column with bonded and 6% Cyanopropylphenyl-94% Dimethyl Polysiloxane (As per USP G43) stationary phase. A dissolveand- injection approach was adopted for sample introduction in a splitless mode. Dichloromethane is used as sample solvent. A limit of detection of about 0.18 ppm and limit of quantitation of about 0.51 ppm were achieved for the Epichlorohydrin in drug substance and drug product samples. The method optimization and validation are also discussed in this paper.