Introduction: A suitable LC-MS method for the quantitative determination of genotoxic impurities such as alkyl p-toluene sulfonates in Cabazitaxel was developed. Alkyl p-toluene sulfonates were estimated by LC-MS method using Waters Symmetry C18 (75×4.6 mm), 3.5 µ column. Materials and Methods: Column temperature was maintained 40 °C. Injection volume was 10 µL and flow rate was set as 0.8 mL/min. Sampler temperature was maintained to 25 °C and run time was set as 25 minutes. The mobile phase was a mixture of ammonium acetate buffer and acetonitrile in 70:30(v/v) was used. Results: The method validation has been carried as per ICH guidelines. LOQ was found to be 2.66 µg/mL, 2.75 µg/mL and 2.55 µg/mL for MPTS, EPTS and IPPTS Alkyl p-Toluene Sulfonates (APTS) respectively. Conclusion: The proposed Liquid chromatography-Mass spectroscopy method that can quantify genotoxic APTS in Cabazitaxel at low-level concentration has been developed and validated as per ICH guidelines. Hence, the proposed method was recommended for the assay of genotoxic impurities of cabazitaxel in dosage forms in busy pharmaceutical laboratories.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2025 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.