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 APIMannem Durga Babu*, Surendra Babu K and Medikondu Kishore
SVRM College (Autonomous) and Research Centre, Acharya Nagarjuna University, Nagaram, Andhra Pradesh, India
- *Corresponding Author:
- Mannem Durga Babu
SVRM College, Acharya Nagarjuna University
Nagaram, Andhra Pradesh, India
E-mail: [email protected]
Received: March 06, 2016 Accepted: April 01, 2016 Published: April 08, 2016
Citation: Babu MD, Babu SK, Kishore K (2016) 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. J Anal Bioanal Tech 7:316. doi:10.4172/2155-9872.1000316
Copyright: © 2016 Babu MD, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.