Title:Determination of Genotoxic alkyl p-toluene Sulfonates in Cabazitaxel using LC-MS Method
VOLUME: 15 ISSUE: 7
Author(s):Bavireddi Mohan*, Ramayanam Siva Kameswara Sharma, Devarakonda Ravi Kumar, Seshagiri Vijaya Murali Mohan Rao and Nutulapati Venkata Satya Venugopal
Affiliation:Department of Chemistry, GITAM (Deemed to be University), Gandhi Nagar, Rushikonda, Visakhapatnam-530045, Andhra Pradesh, Department of Chemistry, GITAM (Deemed to be University), Gandhi Nagar, Rushikonda, Visakhapatnam-530045, Andhra Pradesh, Department of Chemistry, Krishna University, Dr. MRAR PG Centre, Nuzvid-521201, Andhra Pradesh, Department of Chemistry, GITAM (Deemed to be University), Gandhi Nagar, Rushikonda, Visakhapatnam-530045, Andhra Pradesh, Department of Chemistry, Krishna University, Dr. MRAR PG Centre, Nuzvid-521201, Andhra Pradesh
Keywords:Genotoxic impurities, cabazitaxel, Liquid Chromatography-Mass Spectrometry (LC-MS) validation, limit of quantitation,
alkyl p-toluene, cancer.
Abstract:
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.
