Article: Bioanalytical method development and validation of a novel antiseizure agent Cenobamate using LC-MS/MS Journal: International Journal of Nanotechnology (IJNT) 2023 Vol.20 No.1/2/3/4 pp.63 - 74 Abstract: To quantify Cenobamate in human plasma, a precise and sensitive electron ionisation procedure in tandem mass spectrometry has been developed. The study was successfully confirmed by using Cenobamate -D4 as the internal norm and tert-butyl methyl ether in the testing of several positive ionic reactions. It has been used in liquid-liquid extraction to prepare samples as an extraction solvent. Cenobamate and Cenobamate - D4 (internal standard) were separated on an Eclipse C18 column (150 mm, 4.6 mm, 5 μm) by isocratic elution. This process was performed using a mobile phase of 0.1% formic acid in 20:80% v/v ratio of acetonitrile with a flow rate of 0.6 ml/min. The observed mass transitions for Cenobamate and D4 were m/z (amu) 268.23, 198.10 and 272.11 198.10 for each. The lower quantitative limit was 10 ng/ml based on 500 ng/ml plasma, with no chromatogram disturbance observed. A linear curve was observed with a correlation coefficient (r2) of 0.999 from 10 to 500 ng/ml. The intraday and interday precision variations were 15% and the accuracy values were 15% of the relative error values (RE). Extraction recovery rates are in the tolerance ranges of less than 15%. The new LC-MS/MS method complies with all regulatory requirements and demonstrates satisfactory accuracy and accuracy and is sensitive enough to detect Cenobamate in humans. Inderscience Publishers - linking academia, business and industry through research

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Title: Bioanalytical method development and validation of a novel antiseizure agent Cenobamate using LC-MS/MS

Authors: Yamarthi Venkateswara Rao; Rasheed Ahemad Shaik; Jithendra Chimakurthy

Addresses: Faculty of Pharmacy, Vignan's Foundation for Science, Technology and Research, Vadlamudi, Guntur, A.P., 522513, India; Division of Chemistry, Department of Sciences and Humanities, Vignan's Foundation for Science, Technology and Research, Vadlamudi, Guntur, Andhra Pradesh, 522213, India ' Faculty of Pharmacy, Department of Pharmacology and Toxicology, King Abdulaziz University, Jeddah 21589, Saudi Arabia ' Faculty of Pharmacy, Vignan's Foundation for Science, Technology and Research, Vadlamudi, Guntur, A.P., 522513, India

Abstract: To quantify Cenobamate in human plasma, a precise and sensitive electron ionisation procedure in tandem mass spectrometry has been developed. The study was successfully confirmed by using Cenobamate -D4 as the internal norm and tert-butyl methyl ether in the testing of several positive ionic reactions. It has been used in liquid-liquid extraction to prepare samples as an extraction solvent. Cenobamate and Cenobamate - D4 (internal standard) were separated on an Eclipse C18 column (150 mm, 4.6 mm, 5 μm) by isocratic elution. This process was performed using a mobile phase of 0.1% formic acid in 20:80% v/v ratio of acetonitrile with a flow rate of 0.6 ml/min. The observed mass transitions for Cenobamate and D4 were m/z (amu) 268.23, 198.10 and 272.11 198.10 for each. The lower quantitative limit was 10 ng/ml based on 500 ng/ml plasma, with no chromatogram disturbance observed. A linear curve was observed with a correlation coefficient (r2) of 0.999 from 10 to 500 ng/ml. The intraday and interday precision variations were 15% and the accuracy values were 15% of the relative error values (RE). Extraction recovery rates are in the tolerance ranges of less than 15%. The new LC-MS/MS method complies with all regulatory requirements and demonstrates satisfactory accuracy and accuracy and is sensitive enough to detect Cenobamate in humans.

Keywords: Cenobamate; human plasma; epilepsy; robustness; validation; development; LC-MS/MS.

DOI: 10.1504/IJNT.2023.131103

International Journal of Nanotechnology, 2023 Vol.20 No.1/2/3/4, pp.63 - 74

Received: 30 Dec 2020
Accepted: 01 Apr 2021
Published online: 31 May 2023 *

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Title: Bioanalytical method development and validation of a novel antiseizure agent Cenobamate using LC-MS/MS

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