UV Spectrophotometric Method Development and Validation of Fimasartan Drug and Its Tablet Formulation
DOI:
https://doi.org/10.22270/ajprd.v7i5.576Keywords:
UV Spectrophotometer, Fimasartan, Method Validation, LinearityAbstract
A novel, safe and sensitive method of Spectrophotometric estimation in UV - region has been developed for the assay of Fimasartan in its tablet formulation. The present study was undertaken to develop and validate a simple, accurate, precise, reproducible and cost effective UV spectrophotometric method for the estimation of Fimasartan bulk and pharmaceutical formulation. The method have been developed and validated for the assay of Fimasartan using Methanol as diluent. Absorption maximum (λmax) of the drug was found to be 240nm. The quantitative determination of the drug was carried out at 240nm. The method was shown linear in the mentioned concentrations having correlation coefficient R2 of 0.999. The recovery values for Fimasartan ranged from 98.74% to 99.23%.The Percent Relative Standard Deviation of interday and intraday was 0.85% and 0.75% respectively. All the parameters of the analysis were chosen according to the International Conference on Harmonisation guideline and validated statistically using Relative Standard Deviation and Percent Relative Standard Deviation. Hence, proposed method was precise, accurate and cost effective. This method could be applicable for quantitative determination of the bulk drug as well as dosage formulation.
KEY WORDS:
Downloads
References
2. Chatwal G R, Anand S. Instrumental Methods of Chemical Analysis, Himalaya Publishing House, New Delhi, 2005
3. Beckett AH, Stenlake JB. Practical Pharmaceutical chemistry, 4th edition, CBS Publishers and distributors, New Delhi, 2007; 275-278.
4. Pradhan A, Gupta V, Sethi R. Fimasartan: A new armament to fight hypertension, Journal of Family Med Prim Care 2019; 8:2184-8
5. Shin KH, et al. The effect of the newly developed angiotensin receptor II antagonist fimasartan on the pharmacokinetics of atorvastatin in relation to OATP1B1 in healthy male volunteers, Journal of Cardiovascular Pharmacology, 2011; 492-499.
6. Guideline IHT. Validation of Analytical Procedures: Text and Methodology, Q2 (R1), Current Step 4 Version, Parent Guidelines on Methodology, International Conference on Harmonisation, Geneva, Switzerland, 2005
7. Sica D. Rationale for fixed-dose combinations in the treatment of hypertension. Drugs 2002; 443-462.
8. Sohn Y. Crystal forms of an angiotensin II receptor antagonist BR-A657, Journal of Thermal Analysis and Calorimetry 2007; 799-802.
9. Chi YH, Lee H, Paik SH. Safety, tolerability, pharmacokinetics and pharmacodynamics of fimasartan following single and repeated oral administration in the fasted and fed states in healthy subjects, Journal of Cardiovascular Drugs 2011; 11:335-346.
10. Kim JW, Yi S, Kim TE. Increased systemic exposure of fimasartan, an angiotensin II receptor antagonist, by ketoconazole and rifampicin, Journal of Clinical Pharmacology 2013; 53:75-81.
11. Yi S, Kim J, Kim T. Effect of multiple doses of fimasartan, an angiotensin II receptor antagonist, on the steady-state pharmacokinetics of digoxin in healthy volunteers, Journal of Clinical Pharmacology 2011; 49:321-327.
12. Yi S, Kim T-E, Yoon SH. Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers. Journal of Cardiovascular Pharmacology 2011; 57:682-689.
13. Jeon H, Lim KS, Shin K-Hl. Assessment of the drug-drug interactions between fimasartan and hydrochlorothiazide in healthy volunteers. Journal of Cardiovascular Pharmacology 2012; 59:84-91.
14. Ryu S, et al. Fimasartan, anti-hypertension drug, suppressed inducible nitric oxide synthase expressions via nuclear factor-kappa B and activator protein-1 inactivation. Biological and Pharmaceutical Bulletin, 2013; 36(3):467-74.
15. Chi YH, et al. Pharmacological characterization of BR-A-657, a highly potent nonpeptide angiotensin II receptor antagonist. Biological and Pharmaceutical Bulletin. 2013; 36(7):1208-15.
16. Lee HW, et al. Effect of age on the pharmacokinetics of fimasartan (BR-A-657), Expert Opin Drug Metab Toxicology. 2011; 7(11):1337-44.
17. International Conference on Harmonisation, Q2B Validation of Analytical Procedures-Methodology, Consensus¬ Guidelines, ICH Harmonized Tripartite Guidelines, 1996
18. William Foye, Thomas L Lemke, David A Williams, Williams & Wilkins, Principles of Medicinal Chemistry,4th edition, 1996; 544-545.
19. H. Guenzler, Verlag Wegscheider, Validation of Analytical Methods, Accreditation and Quality Assurance in Analytical Chemistry, Berlin, 1996.
20. Phillips PA. Interaction between endothelin and angiotensin II. Clinical and Experimental Pharmacology and Physiology, 1999; 26(7): 517-518.
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).