Abstract

Development and validation of gas chromatography method for low level detection of residual Methyl chloride, Ethyl chloride and Isopropyl chloride in Ziprasidone hydrochloride

Author(s): T.Kaleemullah, Mansur Ahmed, Hemant Kumar Sharma, KVSN Raju, M. Narendra Kumar

A simple and reliable head space gas chromatographic method has been developed for the determination of residual Methyl chloride, Ethyl chloride and Isopropyl chloride in Ziprasidone Hydrochloride. The proposed method is based on flame ionization detection technique with DB- 624 as stationary phase. Linearity of detector response was established up to 13.5μg/g and the detection limit was 0.8μg/g for Methyl chloride, Ethyl chloride and 0.9μg/g for Isopropyl chloride respectively. No interference of organic solvents used in the synthesis was observed. Performance of the method was assessed by evaluating the recovery, repeatability, reproducibility, linearity and limits of detection and quantification. The proposed method has a potential for application to drug substances which may contains traces of alkyl chloride. Results prove that the validated method was suitable for determining the residual Methyl chloride, Ethyl chloride and Isopropyl chloride in Ziprasidone Hydrochloride drug substance. To widen the scope of this method, interference of 17 commonly employed solvents in the synthesis has been studied for any possible interference with Methyl chloride, Ethyl chloride and Isopropyl chloride. The potentiality of method has been studied for various drug substances containing possible alkyl chlorides residue present in their drug matrix.

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