Method Development and Validation of A Novel Anti-Depressant Bupropion by RP-HPLC
DOI:
https://doi.org/10.22270/ajprd.v8i3.720Keywords:
Bupropion, RP-HPLC, PDA detector, ICHAbstract
A speedy, simple and precise RP-HPLC process was developed for the estimation of novel antidepressant drug bupropion with Waters X – Bridge C-18 5µm, 4.6 X 150 mm columnusing mobile phase Acetonitrile: Ammonium bicarbonate (5mM) pH-9 adjusted with 1% Ammonium hydroxide (50:50, %v/v).The flow rate was 1 ml/min and quantification was done by PDA detector at wavelength254nm.The Bupropion eluted from the column in 5.194 min. The validation was carried out in the light of ICH guidelines with respect to parameters linearity, specificity, accuracy, limit of detection (LOD) and limit of quantification (LOQ). The proposed method showed linearity in the concentration range of 50 to 250 ppm for Bupropion. The linear regression equation of Bupropion was found to be y = 6E+06x + 91344 and correlation coefficient value was found to be 0.997 indicating a high degree of linearity for the drug. The limit of detection (LOD) of bupropion was 0.5 ppm and limit of quantification (LOQ) was 2.0 ppm. The low values of %recovery and %C.V. showed that the method is precise within the acceptance limit of 5% (according to ICH guidelines).
Downloads
References
2. Stahl SM, Pradko JF, Haight BR, Modell JG, Rockett CB, Learned-Coughlin S. A review of the neuropharmacology of bupropion, a dual norepinephrine anddopamine reuptake inhibitor. Primary Care Companion to the Journal of Clinical Psychiatry.2004; 6(4): 159- 166.
3. Hari Shanker Sharma. International Review of Neurobiology, New Concepts of Psychostimulant Induced Neurotoxicity In Hugo R. Arias, Abel Santamaria, Syed F. Ali, editors. Chapter 9 – Pharmacological and Neurotoxicological Actions Mediated By Bupropion and Diethylpropion.2009; 88:223-255.
4. Zung WW, Brodie HK, Fabre L, McLendon D, Garver D. Comparative efficacy and safety of bupropion and placebo in the treatment of depression. Psycopharmacology(Berl). 1983; 79(4):343-347.
5. Lief HI. Bupropion treatment of depression to assist smoking cessation. American Journal of Psychiatry. 1996; 153:442a-442.
6. Labbate LA, Grimes JB, Hines A, Pollack MH. Bupropion treatment of serotonin reuptake antidepressant-associated sexual dysfunction. Annals of Clinical Psychiatry. 1997; 9(4):241-245.
7. Plodkowski RA, Nguyen Q, Sundaram U,Nguyen L, Chau DL, St Jeor S. Bupropion and naltrexone: a review of their use individually and in combination for the treatment of obesity. Expert Opin Pharmacotherapy. 2009; 10(6):1069-1081.
8. Cantwell DP. ADHD through the life span: the role of bupropion in treatment. Journal of Clinical Psychiatry. 1998; 59 (4): 92-94.
9. Modell JG, Rosenthal NE, Harriett AE, A.Krishen, Asgharian A, Foster VJ, Metz A, Rockett CB, Wightman DS. Seasonal effective disorder and its prevention by anticipatory treatment with bupropion XL. Biological Psychiatry. 2005; 58(8):658-667.
10. Brustolim D, Riberio-dos-Santos R, Kast RE, Altschuler EL, Soares MB. A new chapter opens in anti-inflammatory treatments: the antidepressant bupropion lowers production of tumor necrosis factor-alpha and interferongamma in mice. International Immunopharmacology. 2006; 6(6):903-907.
11. Schroeder DH. Metabolism and kinetics of Bupropion. Journal of Clinical Psychiatry. 1983; 44(5 Pt 2): 79 - 81.
12. Bryant SG, Guernsey BG, Ingrim NB.Review of bupropion. Clinical Pharmacy. 1983; 2(6):525-537.
13. Johnston AJ, Ascher J, Leadbetter R, Schmith VD, Patel DK, Durcan M, Bentley B.Pharmacokinetic optimization of sustained release bupropion for smoking cessation.Drugs. 2002; 62:11-24.
14. Jinno H, Tanaka-Kagawa T, Ohno A, Makino Y, Matsushima E, Hanioka N, Ando M. Functional characterization of cytochrome P450 2B6 allelic variants. Drug Metabolism and disposition: the biological fate of chemicals. 2003; 31(4):398-403.
15. Hesse LM, Venkatakrishnan K, Court MH, von Moltke LL, Duan SX, Shader RI, Greenblatt DJ. CYP2B6 Mediates the In Vitro Hydroxylation of Bupropion:Potential Drug Interactions with Other antidepressants. Drug Metabolism & Disposition. 2000; 28(10):1176-1183.
16. Biswas, K.M.; Castle, B.C.; Olsen, B.A.; Risley, D.S.; Skibic, M.J.; Wright, P.B. A simple and efficient approach to reversed-phase HPLC method screening, Journal of Pharmaceutical and Biomedical Analysis. 2009; 49:692–701.
17. Staut, T. H.; Dorsay, J. G. High Performance Liquid Chromatography. In: Ohnnesian, L.; Streeter, A. J. Handbook of Pharmaceutical Analysis. 1st ed.; Marcel Dekker, Inc. New York, 2005; 117:87-90.
Published
How to Cite
Issue
Section
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
.