Author(s):
Janardhana Swamy Adabala, Hemalatha K., Narendra Angirekula, Mathrusri Annapurna Mukthinuthalapati
Email(s):
hemalathak.scop@saveetha.com
DOI:
10.52711/0974-360X.2025.00724 
Address:
Janardhana Swamy Adabala1*, Hemalatha K.1, Narendra Angirekula2, Mathrusri Annapurna Mukthinuthalapati3
1Department of Pharmaceutical Chemistry, Saveetha College of Pharmacy, SIMATS, Tamil Nadu, India.
2MSN Laboratories Private Ltd., Hyderabad, Telangana, India.
3GITAM School of Pharmacy, Visakhapatnam, Andhra Pradesh, India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 10,
Year - 2025
ABSTRACT:
A highly sensitive and selective LC-MS/MS method was developed and validated for the determination of N-Nitroso Atomoxetine, a potential nitrosamine impurity in Atomoxetine Oral Solution. Chromatographic separation was achieved using a reversed-phase column and a mobile phase of Acetonitrile: HPLC water: Methanol (75:20:5 v/v/v) with 0.1% formic acid. Detection was performed in positive electrospray ionization mode using multiple reaction monitoring (MRM). The method showed excellent specificity, linearity (R² = 0.9995), sensitivity (LOD: 0.1 ppb; LOQ: 0.2 ppb), and precision (RSD < 2.6%). Recoveries ranged from 104.3% to 109.2%. This validated method meets regulatory expectations for nitrosamine drug substance-related impurities (NDSRIs) and offers a robust analytical solution for quality control and risk mitigation in Atomoxetine formulations.
Cite this article:
Janardhana Swamy Adabala, Hemalatha K., Narendra Angirekula, Mathrusri Annapurna Mukthinuthalapati. Advanced LC-MS/MS method for the determination of N-Nitroso Atomoxetine in Atomoxetine oral solution: Ensuring drug safety. Research Journal of Pharmacy and Technology. 2025;18(10):5011-6. doi: 10.52711/0974-360X.2025.00724
Cite(Electronic):
Janardhana Swamy Adabala, Hemalatha K., Narendra Angirekula, Mathrusri Annapurna Mukthinuthalapati. Advanced LC-MS/MS method for the determination of N-Nitroso Atomoxetine in Atomoxetine oral solution: Ensuring drug safety. Research Journal of Pharmacy and Technology. 2025;18(10):5011-6. doi: 10.52711/0974-360X.2025.00724 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-10-63
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