Determination of Irbesartan in Pharmaceutical Preparations by Polarographic Methods

Year 2024, , 1081 - 1090, 30.08.2024

Bilal Yılmaz , Aytekin Korkmaz , Semih Yılmaz , Yücel Kadıoğlu

https://doi.org/10.18596/jotcsa.1387493

Abstract

In this study, the polarographic behavior of irbesartan was investigated using the cyclic polarographic method. A mercury drop electrode was used to quantify the peak currents in comparison to Ag/AgCl at 0.10 V/s. Additionally, quick and easy square wave and differential pulse polarographic methods were developed and validated to determine irbesartan in pharmaceutical preparations. For both methods, the calibration curves were linear at concentrations between 5 and 70 μg/mL. The precision was given by relative standard deviation and was less than 2.61%. Accuracy was given with relative error and did not exceed 1.24%. The suggested methods are extremely accurate and precise. No interference was found under the chosen experimental conditions. In pharmaceutical preparations, irbesartan had an average recovery of 99.8%. Therefore, the methods are applicable to the determination of irbesartan in pharmaceutical preparations.

Keywords

Irbesartan, Polarography, Validation, Tablet

References

• 1. Foley R, Parfrey P, Sarnak M. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis [Internet]. 1998 Nov;32(5):S112–9. Available from: <URL>.
• 2. Nguyen Q, Dominguez J, Nguyen L, Gullapalli N. Hypertension management: an update. Am Heal drug benefits [Internet]. 2010 Jan;3(1):47–56. Available from: <URL>.
• 3. Kurbanoğlu S, Yarman A. Simultaneous Determination of Hydrochlorothiazide and Irbesartan from Pharmaceutical Dosage Forms with RP-HPLC. Turkish J Pharm Sci [Internet]. 2020 Oct 1;17(5):523–7. Available from: <URL>.
• 4. Ramakrishna S, SudhaLakshmi PB, Rambabu C. Visible spectrophotometric methods for the determination of irbesartan in pharmaceutical formulations. Int J Pharm Pharm Sci. 2012;4(3):86–7.
• 5. Albero I, Ródenas V, Garcı́a S, Sánchez-Pedreño C. Determination of irbesartan in the presence of hydrochlorothiazide by derivative spectrophotometry. J Pharm Biomed Anal [Internet]. 2002 Jun 20;29(1–2):299–305. Available from: <URL>.
• 6. Ganesh K, Balraj C, Elango KP. Spectroscopic and spectrofluorimetric studies on the interaction of irbesartan with 2,3-dichloro-5,6-dicyano-1,4-benzoquinone and iodine. Spectrochim Acta Part A Mol Biomol Spectrosc [Internet]. 2011 Sep 1;79(5):1621–9. Available from: <URL>.
• 7. Abdellatef HE. Extractive-spectrophotometric determination of disopyramide and irbesartan in their pharmaceutical formulation. Spectrochim Acta Part A Mol Biomol Spectrosc [Internet]. 2007 Apr 1;66(4–5):1248–54. Available from: <URL>.
• 8. Erk N. Three new spectrophotometric methods applied to the simultaneous determination of hydrochlorothiazide and irbesartan. Pharmazie [Internet]. 2003;58(8):543–8. Available from: <URL>.
• 9. Sivasubramanian L, Lakshmi KS. H-point standard addition method for simultaneous spectrophotometric determination of irbesartan, hydrochlorothiazide and telmisartan in tablets. Internatıonal J Res Pharm Chemıstry [Internet]. 2014;4(2):373–80. Available from: <URL>.
• 10. Pradhan KK, Pradhan KK, Mishra US, Pattnaik S, Mishra D, Panigrahi G, et al. Method Development, Validation and Stability Study of Irbesartan in Bulk and Pharmaceutical Dosage Form by UV-Spectrophotometric Method. Int J Pharm Biol Arch [Internet]. 2011;2(4):1114–22. Available from: <URL>.
• 11. Omar MA, Abdelmageed OH, Abdel-Gaber AA, Abdel-Megied AM. Spectrophotometric and spectrofluorimetric determination of certain angiotensin receptor blockers through complex formation. J Pharm Sci Res [Internet]. 2011 Oct 1;3(10):1499–510. Available from: <URL>.
• 12. Hillaert S, Van den Bossche W. Optimization and validation of a capillary zone electrophoretic method for the analysis of several angiotensin-II-receptor antagonists. J Chromatogr A [Internet]. 2002 Dec 6;979(1–2):323–33. Available from: <URL>.
• 13. Ferreirós N, Dresen S, Alonso RM, Weinmann W. Validated Quantitation of Angiotensin II Receptor Antagonists (ARA-II) in Human Plasma by Liquid-Chromatography-Tandem Mass Spectrometry Using Minimum Sample Clean-up and Investigation of Ion Suppression. Ther Drug Monit [Internet]. 2007 Dec;29(6):824–34. Available from: <URL>.
• 14. Gonzalez O, Alonso RM, Ferreirós N, Weinmann W, Zimmermann R, Dresen S. Development of an LC–MS/MS method for the quantitation of 55 compounds prescribed in combined cardiovascular therapy. J Chromatogr B [Internet]. 2011 Feb 1;879(3–4):243–52. Available from: <URL>.
• 15. Qiu X, Wang Z, Wang B, Zhan H, Pan X, Xu R ai. Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma by ultra high performance liquid chromatography tandem mass spectrometry and its application to a bioequivalence study. J Chromatogr B [Internet]. 2014 Apr 15;957:110–5. Available from: <URL>.
• 16. Lu CY, Feng CH. Quantitation of irbesartan and major proteins in human plasma by mass spectrometry with time-of-flight analyzer. J Pharm Biomed Anal [Internet]. 2011 Jan 5;54(1):100–5. Available from: <URL>.
• 17. Bae SK, Kim M, Shim E, Cho D, Shon J, Liu K, et al. HPLC determination of irbesartan in human plasma: its application to pharmacokinetic studies. Biomed Chromatogr [Internet]. 2009 Jun 10;23(6):568–72. Available from: <URL>.
• 18. Rao RN, Bompelli S, Maurya PK. High‐performance liquid chromatographic determination of anti‐ hypertensive drugs on dried blood spots using a fluorescence detector – method development and validation. Biomed Chromatogr [Internet]. 2011 Nov 10;25(11):1252–9. Available from: <URL>.
• 19. Ferreiros N, Iriarte G, Alonso R, Jimenez R. Development of a solid phase extraction procedure for HPLC–DAD determination of several angiotensin II receptor antagonists in human urine using mixture design. Talanta [Internet]. 2007 Oct 15;73(4):748–56. Available from: <URL>.
• 20. Hafez HM, Elshanawane AA, Abdelaziz LM, Kamal MM. Quantitative Determination of three Angiotensin-II-receptor Antagonists in Presence of Hydrochlorothiazide by RP-HPLC in their Tablet Preparations. Iran J Pharm Res IJPR [Internet]. 2013;12(4):635–43. Available from: <URL>.
• 21. Shakya AK, Al-Hiari YM, Alhamami OMO. Liquid chromatographic determination of irbesartan in human plasma. J Chromatogr B [Internet]. 2007 Apr 1;848(2):245–50. Available from: <URL>.
• 22. Koyuturk S, Can NO, Atkosar Z, Arli G. A novel dilute and shoot HPLC assay method for quantification of irbesartan and hydrochlorothiazide in combination tablets and urine using second generation C18-bonded monolithic silica column with double gradient elution. J Pharm Biomed Anal [Internet]. 2014 Aug 25;97:103–10. Available from: <URL>.
• 23. Laviron E, Roullier L, Degrand C. A multilayer model for the study of space distributed redox modified electrodes. J Electroanal Chem Interfacial Electrochem [Internet]. 1980 Sep 10;112(1):11–23. Available from: <URL>.
• 24. Wang J. Electroanalytical techniques in clinical chemistry and laboratory medicine [Internet]. New York: VCH Publishers; 1988. Available from: <URL>.
• 25. Kissinger PT, Heineman WR. Laboratory Techniques in Electroanalytical Chemistry [Internet]. Journal of the American Chemical Society. New York: Marcel Dekker, Inc.; 1996. Available from: <URL>.
• 26. Bozal B, Doğan-Topal B, Uslu B, Özkan SA, Aboul-Enein HY. Quantitative Analysis of Irbesartan in Pharmaceuticals and Human Biological Fluids by Voltammetry. Anal Lett [Internet]. 2009 Sep 23;42(14):2322–38. Available from: <URL>.
• 27. The European Agency for the Evaluation of Medicinal Products. ICH Topic Q2B Note for Guideline on Validation of Analytical Procedures: Methodology GPMP/ICH/281/95 [Internet]. 1996. Available from: <URL>.
• 28. El-Hefnawey G., El-Hallag I., Ghoneim E., Ghoneim M. Voltammetric behavior and quantification of the sedative-hypnotic drug chlordiazepoxide in bulk form, pharmaceutical formulation and human serum at a mercury electrode. J Pharm Biomed Anal [Internet]. 2004 Jan 27;34(1):75–86. Available from: <URL>.
• 29. Corti P, Corbini G, Gratteri P, Furlanetto S, Pinzauti S. Determination of some quinolones in tablets, human plasma and urine by differential-pulse polarography. Int J Pharm [Internet]. 1994 Oct 6;111(1):83–7. Available from: <URL>.
• 30. British Pharmacopoeia, The Stationary Office, London, 2003. Available from: <URL>.