Development and Validation of a GC-MS with SIM Method for the Determination of Trace Levels of Methane Sulfonyl Chloride as an Impurity in Itraconazole API

Abstract

Selected-ion monitoring (SIM) mode mass selective detection was developed and validated for the trace analysis of an impurity, methane sulfonyl chloride as an impurity in Itraconazole (ICR) active pharmaceutical ingredient (API). The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. Accurate and precise quantitation of the impurity in drug substance was achieved with external standardization. In this research work, we present a summary of the method development and validation work performed on Methane sulfonyl chloride (MSC) in Itraconazole API by GC/MS-SIM technique. In the method development phase, the analytical procedure that is appropriate for the quantitative analysis of the MSC in ICR at ppm level was established and evaluated.