Analyzing three genotoxic impurities of atorvastatin calcium employing gc-ms single quad detector with electron impact technology

• Main Authors: Devanna, N. (Author), Rajput, R.K (Author), Sahai, M. (Author)
• Format: Article
• Language: English
• Published: Rasayan Journal of Chemistry, c/o Dr. Pratima Sharma 2021
• Subjects: Atorvastatin Calcium; Gas Chromatography; Genotoxic; Impurities; Mass Spectrometer
• Online Access: View Fulltext in Publisher

 This paper described the first report on GC-MS methodology development and validation for the simultaneous determination of potential genotoxic materials, ethyl methanesulfonate (ELMS), methyl methanesulfonate (MLMS), and isopropyl methanesulfonate (ILMS), in Atorvastatin calcium (ATC). The quantification limits for this methodology ranged from 0.0115 to 0.0767 ppm (ELMS), 0.0111 to 0.0738 ppm (ILMS) and 0.0129 to 0.0858 ppm (MLMS). This methodology has presented excellent eminence parameters for case, linearity (squared correlation coefficient value > 0.990), precision for method (0.6-1.1%, n=6), ruggedness (1.1-2.1%, n=12), system suitability (5.1-6.1%, n = 6) in relations of relative standard deviation percentage. The recovery values attained in low, medium and high levels of spiked ATC samples were between 87.8% and 119.1%. The GC-MS methodology demonstrates its versatility in evaluating ELMS, ILMS and MLMS concurrently in ATC 's daily quality assurance evaluations. © 2021, Rasayan Journal of Chemistry, c/o Dr. Pratima Sharma. All rights reserved.