Author(s): Mohan Gandhi Bonthu, G.Raveendra Babu, Bhaskara Raju Vatchavai, Nirmala Korukola, Alluri Pavani Gayatri

Email(s): upendragudimitla@gmail.com

DOI: 10.52711/0974-360X.2024.00422   

Address: Mohan Gandhi Bonthu1, G.Raveendra Babu2*, Bhaskara Raju Vatchavai3, Nirmala Korukola4, Alluri Pavani Gayatri1
1Department of Pharmaceutical Analysis, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru, Andhra Pradesh, India.
2Department of Pharmaceutical Analysis, QIS College of Pharmacy, Vengamukkapalem, Ongole, Andhra Pradesh, India.
3Department of Pharmaceutical Analysis, Sri Vasavi Institute of Pharmaceutical Sciences, Tadepalligudem, Andhra Pradesh, India.
4Department of Pharmacognosy, KGRL College of Pharmacy, Bhimavaram, Andhra Pradesh, India.
*Corresponding Author

Published In:   Volume - 17,      Issue - 6,     Year - 2024


ABSTRACT:
This study describes a new method for accurately measuring baloxavir marboxil (BXM) in human plasma using LC-API-MS/MS. We employed baloxavir marboxil d4 as an internal standard for precise quantification. BXM and the internal standard were isolated from plasma using tert-butyl methyl ether (TBME) extraction. The LC system separated BXM and the internal standard on a Zorbax SB C18column, and tandem mass spectrometry (MS/MS) detected them with minimal interference from human plasma components. The method showed excellent linearity (R²=0.9956) across a wide concentration range (10.610–1229.080ng/mL). BXM stability was evaluated under various conditions, including room temperature, injector storage, freeze-thaw cycles, and long-term storage at -70°C. The method was validated according to USFDA guidelines, demonstrating its effectiveness for quantifying BXM in human plasma for pharmacokinetic studies.


Cite this article:
Mohan Gandhi Bonthu, G.Raveendra Babu, Bhaskara Raju Vatchavai, Nirmala Korukola, Alluri Pavani Gayatri. An Improved approach for Creating and Validating a Bioanalytical Method to Quantify Baloxavir Marboxil in Human Plasma using LC-API-MS/MS. Research Journal of Pharmacy and Technology. 2024; 17(6):2694-8. doi: 10.52711/0974-360X.2024.00422

Cite(Electronic):
Mohan Gandhi Bonthu, G.Raveendra Babu, Bhaskara Raju Vatchavai, Nirmala Korukola, Alluri Pavani Gayatri. An Improved approach for Creating and Validating a Bioanalytical Method to Quantify Baloxavir Marboxil in Human Plasma using LC-API-MS/MS. Research Journal of Pharmacy and Technology. 2024; 17(6):2694-8. doi: 10.52711/0974-360X.2024.00422   Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-6-41


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