Abstract

DEVELOPMENT AND VALIDATION OF A HEAD SPACE GAS CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF ETHYLENE OXIDE CONTENT IN DIPYRIDAMOLE API

Sagi Sambamurthy Raju*, U. Vidyamani, P.Jayapal, P. Naga Raju

Abstract

To provide quality control over the manufacture of any API, it is essential to develop highly selective analytical methods. Gas chromatography with Head space (HSGC) is widely used for the determination of residual impurities and solvents in API’s. In the current article we are reporting the development and validation of a rapid and specific Head space gas chromatographic (HSGC) method for the determination of Ethylene oxide in Dipyridamole API. The developed method was validated in terms of Specificity, Linearity, Precision, Accuracy, Limit of detection (LOD) and Limit of quantitation (LOQ) and Precision and Accuracy at LOQ. The developed method was utilized for the investigation of Ethylene oxide content in bulk drug.

Keywords: Ethylene oxide, Dipyridamol, Head Space Gas Chromatography, Method development, Method validation.