Development and Validation of a Headspace Gas Chromatographic Method for the Determination of Methyl Bromide Content in Itraconazole API

To provide quality control over the manufacture of any API, it is essential to develop highly selective analytical methods. Gas chromatography with headspace (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 methyl bromide in Itraconazole API. The developed method was validated in terms of specificity, linearity, precision, accuracy, limit of detection (LOD) and limit of quantitation (LOQ). The developed method was utilized for the investigation of methyl bromide content in bulk drug.