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Trace analysis of mesityl oxide and diacetone alcohol in pharmaceuticals by capillary gas chromatography with flame ionization detection

K.Rama Seshaiah, V.Krishna Reddy, Ch.Krishnaiah, VVNKV Prasadaraju, K.Mukkanti, V.Ranga Reddy

A capillary gas chromatographic method using flame ionization detection was developed and validated for the trace analysis (ppm level) of mesityl oxide and diacetone alcohol in pharmaceutical drug substance. The method utilizes a megabore capillary column with bonded and crosslinked polyethylene glycol stationary phase. A dissolve-and-injection approach was adopted for sample introduction in a split mode (1:1). Water is used as sample solvent. A limit of detection of about 1.5 and 2 ppm and limit of quantitation of about 6 and 10 ppm were achieved for the Mesityl oxide and Diacetone alcohol in drug substance samples. The method optimization and validation are also discussed in this paper.