Author(s):
Uttam Prasad Panigrahy, Aswini Kumar Parida, Satyabrata Bhanja
Email(s):
uttampanigrahy@gmail.com
DOI:
10.52711/0974-360X.2025.00612
Address:
Uttam Prasad Panigrahy1, Aswini Kumar Parida2, Satyabrata Bhanja3
1Faculty of Pharmaceutical Science, Assam Down Town University, Sankar Madhab Path, Gandhi Nagar, Panikhaiti, Guwahati, Assam, India.
2Berhampur University, Berhampur - 760007, Odisha, India.
3RITEE College of Pharmacy, NH-6, Chhatauna, Mandir Hasaud, Raipur, Chhattisgarh, India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 9,
Year - 2025
ABSTRACT:
The quantification and analytical validation of Atomoxetine was developed with a stationary phase Phenomenex column C18 (4.6mm×250mm, 5µm) and LC1220 Agilent HPLC instrument equipped with variable wavelength detector at 270nm and Acetonitrile: Water containing 0.2% of triethylamine (85:15, v/v) was used as mobile phase passed at a flow rate 1mL/min. Elution takes place at retention time of 2.283min. Validation of method were performed as per ICH guidelines which shows linearity concentration range from 10-125µg/mL amid Correlation coefficient=0.999 with Y = 63164x+64858 regression equation obtained. LOD and LOQ of Atomoxetine were 0.07µg/mL and 0.21µg/mL correspondingly. Recovery of Atomoxetine was obtained 99.83-100.14%.
Cite this article:
Uttam Prasad Panigrahy, Aswini Kumar Parida, Satyabrata Bhanja. Quantification and Analytical Validation of Atomoxetine by Liquid Chromatographic Method through Isocratic Separation in Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology. 2025;18(9):4264-8. doi: 10.52711/0974-360X.2025.00612
Cite(Electronic):
Uttam Prasad Panigrahy, Aswini Kumar Parida, Satyabrata Bhanja. Quantification and Analytical Validation of Atomoxetine by Liquid Chromatographic Method through Isocratic Separation in Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology. 2025;18(9):4264-8. doi: 10.52711/0974-360X.2025.00612 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-9-32
REFERENCES:
1. Jaswinder GK. Hutchison SL. Atomoxetine is a second-line medication treatment option for ADHD. Evidence Based Mental Health. 2014; 17 (4): 108. doi: 10.1136/eb-2014-101805.
2. Merugu M. Aanandhi MV. Stability Indicating Method Development and Validation of Semaglutide by RP-HPLC in Pharmaceutical substance and Pharmaceutical Product. Research Journal of Pharmacy and Technology. 2021; 14(3): 1385-1389.doi: 10.5958/0974-360X.2021.00247.X.
3. Panigrahy UP. Bhanja S. Hoque N. Gandla K. A novel analytical approach for simultaneous estimation of Levofloxacin and Ambroxol HCl by HPLC-DAD method with degradation studies. European Chemical Bulletin. 2023; 12(4): 1777-1785. doi:10.31838/ecb/2023.12.4.134.
4. Patel K. Shah UA. Joshi HV. Patel JK. Patel CN. QbD Stressed Development and Validation of Stability-Indicating RP- HPLC Method for the Simultaneous Estimation of Linagliptin and Metformin HCl in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(5): 1917-3. doi: 10.52711/0974-360X.2022.00319.
5. Shinde A. Gajeli GB. Ubale S. Matole V. Simultaneous HPLC Method Development and Validation of Bilastine and Montelukast in Bulk and Formulation. Research Journal of Pharmacy and Technology. 2021; 14(11): 6061-5. doi: 10.52711/0974-360X.2021.01053.
6. Dilek AK. Yeniceli D. A simple and specific HPLC method for the determination of atomoxetine in pharmaceuticals and human plasma. Journal of Liquid Chromatography and Related Technologies. 2010; 33(19): 1745-1759. doi:10.1080/10826076.2010.526816.
7. Bose B. Panigrahy UP. Gupta JK. Sonawane R. Chandan RS. Anupama GV. Determination and quanitification of Cypermethrin pesticide residue in cucumber using RP-HPLC. European Chemical Bulletin. 2023; 12(4): 235-246.doi:10.31838/ecb/2023.12.4.018.
8. Tanuja A. Ganapaty S. Murthy VSN. Stability Indicating RP-HPLC Method Development and Validation for the Determination of Solifenacin Succinate in Bulk and its Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2021; 14(7): 3509-4. doi: 10.52711/0974-360X.2021.00608.
9. Guo W. Li W. Guo G. Zhang J. Zhou B. Zhai Y. Wang C. Determination of atomoxetine in human plasma by a high performance liquid chromatographic method with ultraviolet detection using liquid-liquid extraction. J Chromatogr B Analyt Technol Biomed Life Sci. 2007; 854: 128–134. doi: 10.1016/j.jchromb.2007.04.007.
10. Pathan MA. Kshirsagar A. Stability Indicating HPLC Method Development and Validation for Simultaneous Estimation of Metformin and Empagliflozin in Bulk and Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(2): 830-6. doi: 10.52711/0974-360X.2022.00138.
11. Panigrahy UP. Bhanja S. Panda PK. Development and Validation of Stability Indicating Method for Terazosin in Bulk and Pharmaceutical Formulation by UV-Spectrophotometer. International Journal of Zoological Investigations. 2023; 9(2): 747-756. doi:10.33745/ijzi.2023.v09i02.084.
12. Panigrahy UP. Roy A. Hussain SA. Das KP. Deka A. Stability indicating method development and validation of Imeglimin Hydrochloride in bulk and pharmaceutical formulation by UV-Spectrophotometer. African Journal of Biological Sciences. 2024; 6(11): 811-823. doi: 10.33472/AFJBS.6.11.2024.811-823.
13. Panigrahy UP. Sahoo NK. Reddy ASK. Development and Validation of Entacapone in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry. Asian Journal of Chemistry. 2015; 27(12): 4669–4674. doi:https://doi.org/10.14233/ajchem.2015.19323.
14. Marchei E. Papaseit E. Garcia-Algar OQ. Farre M. Pacifici R. Pichini S. Determination of Atomoxetine and its metabolites in conventional and non-conventional biological matrices by liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal. 2012; 60:26-31. doi: 10.1016/j.jpba.2011.11.009.
15. Choi CI. Jang CG. Bae JW. Lee SY. Validation of an analytical LC-MS/MS method in human plasma for the pharmacokinetic study of atomoxetine. J Anal Chem. 2013; 68: 986–991. doi:10.1134/S1061934813110051.
16. Reddy S. Thomas L. Venkatesan P. Mukhopadhyay A. Thangam S. Simultaneous Estimation of Ampicillin and Sulbactam in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry. Asian Journal of Pharmaceutical Analysis. 2023; 13(1): 13-0. doi: 10.52711/2231-5675.2023.00003.
17. Maruthi R. Chandan RS. Tengli AK. Characterization of impurities in Teneligliptin hydrobromide hydrate by using LCMS/MS and NMR. Research J. Pharm. and Tech. 2020; 13(8): 3569-3576. doi: 10.5958/0974-360X.2020.00631.9.
18. Shabir GA. Validation of high-performance liquid chromatography methods for pharmaceutical analysis. Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. J Chromatogr A. 2003; 987: 57-66. doi: 10.1016/s0021-9673(02)01536-4.