Research Article
BibTex RIS Cite

Determination of Irbesartan in Pharmaceutical Preparations by HPLC

Year 2025, Volume: 46 Issue: 2, 206 - 211, 30.06.2025

Bilal Yılmaz

https://doi.org/10.17776/csj.1485381

Abstract

In this study, a high-performance liquid chromatography (HPLC) method was developed to analyze irbesartan in both pure and pharmaceutical formulations. The mobile phase consisted of an acetonitrile-1.0 mM potassium dihydrogen phosphate solution (30:70, v/v), adjusted to pH 3.0 with phosphoric acid. The analysis was performed using an Ace C18 column, and a UV detector was employed to monitor the eluent at 220 nm. With a flow rate of 1.0 mL min-1, the analysis was completed in under 6 minutes. The calibration curve was linear across the concentration range of 0.10-5.0 μg mL-1. The accuracy of the method (relative error) for irbesartan was better than 2.67%, and the intra- and inter-day precision values were below 3.23%. The mean recovery of irbesartan in pharmaceutical formulations was 101.4%. The limits of detection and quantitation were found to be 0.03 and 0.10 μg mL-1, respectively. Furthermore, the method proved to be effective for quantifying the drug and confirming the consistency of the formulation content in commercial irbesartan dosage forms.

Keywords

Irbesartan HPLC Validation Drug analysis.

References

  • [1] Foley R.N., Parfrey P.S., Sarnak M.J., Clinical Epidemiology of Cardiovascular Disease in Chronic Renal Disease, Am J Kidney Dis., (1998) S16-S23.
  • [2] Nguyen Q., Dominguez J., Nguyen L., Gullapalli N., Hypertension Management: An Update, Am Health Drug Benefits, 3 (2010) 47-56.
  • [3] Kurbanoğlu S., Yarman A., Simultaneous Determination of Hydrochlorothiazide and Irbesartan from Pharmaceutical Dosage Forms with RP-HPLC, Turkish J Pharm Sci., 17(5) (2020) 523-527.
  • [4] Ramakrishna S., SudhaLakshmi P.B., Rambabu C., Visible Spectrophotometric Methods for the Determination of irbesartan in Pharmaceutical Formulations, International J Pharm Pharmaceut Sci., 4(3) (2012) 86-87.
  • [5] Albero I., Rodenas V., Garcia S., Sánchez-Pedreno C., Determination of Irbesartan in the Presence of Hydrochlorothiazide by Derivative Spectrophotometry, J Pharm Biomed Anal., 29(1-2) (2002) 299-305.
  • [6] Ganesh K., Balraj C., Elango K.P., 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., 79(5) (2011) 1621-1629.
  • [7] Abdellatef H.E., Extractive-Spectrophotometric Determination of Disopyramide and Irbesartan in their Pharmaceutical Formulation, Spectrochim Acta Part A., 66(4-5) (2007) 1248-1254.
  • [8] Erk N., Three New Spectrophotometric Methods Applied to the Simultaneous Determination of Hydrochlorothiazide and Irbesartan, Pharmazie, 58(8) (2003) 543-548.
  • [9] Lakshmi S., Lakshmi K.S., H-Point Standard Addition Method for Simultaneous Spectrophotometric Determination of Irbesartan, Hydrochlorothiazide and Telmisartan in Tablets, International J Res Pharm Chem., 4(2) (2014) 373-380.
  • [10] Pradhan K.K., Mishra U.S., Pattnaik S., Debananda M., Ghanshyam P., Sahu K.C., Method Development, Validation and Stability Study of Irbesartan in Bulk and Pharmaceutical Dosage Form by UV-Spectrophotometric Method, International J Pharm Biological Arch., 2(4) (2011) 1114-1122.
  • [11] Mahmoud A., Sama H.A., Ahmed A.A., Ahmed M.A., Spectrophotometric and Spectrofluorimetric Determination of Certain Angiotensin Receptor Blockers through Complex Formation, J Pharm Sci Research, 3(10) (2011) 1499-1510.
  • [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., 979(1-2) (2002) 323-333.
  • [13] Ferreiros N., Dresen S., Alonso R.M., 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, Therap Drug Monitor., 29(6) (2007) 824-834.
  • [14] Gonzalez O., Alonso R.M., Ferreiros 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., 879 (2011) 243-252.
  • [15] Qui X., Wang Z., Wang B., Zhan H., Pan X., Xu R., Simultaneous Determination of Irbesartan and Hydrochlorothiazide in Human Plasma by Ultra High Performance Liquid Chromatography Tandem Mass Spectrometry and its Application to the Bioequivalence Study, J Chromatogr B., 957 (2014) 110-115.
  • [16] Lu C.Y., Feng C.H., Quantitation of Irbesartan and Major Proteins in Human Plasma by Mass Spectrometry with Time-of-Flight Analyzer, J Pharm Biomed Anal., 54(1) (2011) 100-105.
  • [17] Bae S.K., Kim M.J., Shim E.J., Cho D.Y., Shon J.H., Liu K.H., Kim E.Y., Shin J.G., HPLC Determination of Irbesartan in Human Plasma: its Application to Pharmacokinetic Studies, Biomed Chromatogr., 23(6) (2009) 568-572.
  • [18] Rao R.N, Bompelli S., Maurya P.K., High-Performance Liquid Chromatographic Determination of Anti-Hypertensive Drugs on Dried Blood Spots Using a Fluorescence Detector-Method Development and Validation, Biomed Chromatogr., 25(11) (2011) 1252-1259.
  • [19] Ferreirós N., Iriarte G., Alons R.M., Jiménez R.M., Development of a Solid Phase Extraction Procedure for HPLC-DAD Determination of Several Angiotensin II Receptor Antagonists in Human Urine using Mixture Design, Talanta, 73(4) (2007) 748-756.
  • [20] Hafez H.M., Elshanawane A.A., Abdelaziz L.M., Kamal M.M.Quantitative Determination of Three Angiotensin-II-Receptor Antagonists in Presence of Hydrochlorothiazide by RP-HPLC in their tablet preparations, Iranian J Pharm Res., 12 (2013) 635-643.
  • [21] Shakya A.K, Al-Hiari Y.M, Alhamami O.M.O., Liquid Chromatographic Determination of İrbesartan in Human Plasma, J Chromatogr B., 848(2) (2007) 245-50.
  • [22] Koyuturk S., Can N.O., 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., 97 (2014) 103-110.
  • [23] Vagamani M., Sahoo S.K., Kavitha D., Vagyalaxmi C.H., Mahapatra L., Validated RPHPLC Method for Simultaneous Estimation of Irbesartan and Hydrochlorothiazide in Tablet Dosage Form. Int J Pharm Res and Health Sci., 5 (2017) 1419-23.
  • [24] Rao K.T., Rao L.V., Kandepi K.M., Rapid Stability-indicating RRLC Method for Simultaneous Estimation of Irbesartan and its Related Impurities. Indian J Pharm Sci., 78 (2016) 252-58.
  • [25] Kissenger P.T., Heineman W.R., (Eds.), Laboratory Techniques in Electroanalytical Chemistry, 2nd Ed., Marcel Dekker, New York, (1996).
  • [26] The United States Pharmacopoeia, Thirtieth Revision, and The National Formulary, 25th ed., Rockville, USA, (2007) 1802-1805.
  • [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 (1996).
  • [28] El-Hefnawey G.B., El-Hallag I.S., Ghoneim E.M., Ghoneim M.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., 34 (2004) 75-86.
  • [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, International J Pharm., 111 (1994) 83-87.
  • [30] British Pharmacopoeia, The Stationary Office, London, (2003).

Year 2025, Volume: 46 Issue: 2, 206 - 211, 30.06.2025

Bilal Yılmaz

https://doi.org/10.17776/csj.1485381

Abstract

References

  • [1] Foley R.N., Parfrey P.S., Sarnak M.J., Clinical Epidemiology of Cardiovascular Disease in Chronic Renal Disease, Am J Kidney Dis., (1998) S16-S23.
  • [2] Nguyen Q., Dominguez J., Nguyen L., Gullapalli N., Hypertension Management: An Update, Am Health Drug Benefits, 3 (2010) 47-56.
  • [3] Kurbanoğlu S., Yarman A., Simultaneous Determination of Hydrochlorothiazide and Irbesartan from Pharmaceutical Dosage Forms with RP-HPLC, Turkish J Pharm Sci., 17(5) (2020) 523-527.
  • [4] Ramakrishna S., SudhaLakshmi P.B., Rambabu C., Visible Spectrophotometric Methods for the Determination of irbesartan in Pharmaceutical Formulations, International J Pharm Pharmaceut Sci., 4(3) (2012) 86-87.
  • [5] Albero I., Rodenas V., Garcia S., Sánchez-Pedreno C., Determination of Irbesartan in the Presence of Hydrochlorothiazide by Derivative Spectrophotometry, J Pharm Biomed Anal., 29(1-2) (2002) 299-305.
  • [6] Ganesh K., Balraj C., Elango K.P., 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., 79(5) (2011) 1621-1629.
  • [7] Abdellatef H.E., Extractive-Spectrophotometric Determination of Disopyramide and Irbesartan in their Pharmaceutical Formulation, Spectrochim Acta Part A., 66(4-5) (2007) 1248-1254.
  • [8] Erk N., Three New Spectrophotometric Methods Applied to the Simultaneous Determination of Hydrochlorothiazide and Irbesartan, Pharmazie, 58(8) (2003) 543-548.
  • [9] Lakshmi S., Lakshmi K.S., H-Point Standard Addition Method for Simultaneous Spectrophotometric Determination of Irbesartan, Hydrochlorothiazide and Telmisartan in Tablets, International J Res Pharm Chem., 4(2) (2014) 373-380.
  • [10] Pradhan K.K., Mishra U.S., Pattnaik S., Debananda M., Ghanshyam P., Sahu K.C., Method Development, Validation and Stability Study of Irbesartan in Bulk and Pharmaceutical Dosage Form by UV-Spectrophotometric Method, International J Pharm Biological Arch., 2(4) (2011) 1114-1122.
  • [11] Mahmoud A., Sama H.A., Ahmed A.A., Ahmed M.A., Spectrophotometric and Spectrofluorimetric Determination of Certain Angiotensin Receptor Blockers through Complex Formation, J Pharm Sci Research, 3(10) (2011) 1499-1510.
  • [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., 979(1-2) (2002) 323-333.
  • [13] Ferreiros N., Dresen S., Alonso R.M., 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, Therap Drug Monitor., 29(6) (2007) 824-834.
  • [14] Gonzalez O., Alonso R.M., Ferreiros 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., 879 (2011) 243-252.
  • [15] Qui X., Wang Z., Wang B., Zhan H., Pan X., Xu R., Simultaneous Determination of Irbesartan and Hydrochlorothiazide in Human Plasma by Ultra High Performance Liquid Chromatography Tandem Mass Spectrometry and its Application to the Bioequivalence Study, J Chromatogr B., 957 (2014) 110-115.
  • [16] Lu C.Y., Feng C.H., Quantitation of Irbesartan and Major Proteins in Human Plasma by Mass Spectrometry with Time-of-Flight Analyzer, J Pharm Biomed Anal., 54(1) (2011) 100-105.
  • [17] Bae S.K., Kim M.J., Shim E.J., Cho D.Y., Shon J.H., Liu K.H., Kim E.Y., Shin J.G., HPLC Determination of Irbesartan in Human Plasma: its Application to Pharmacokinetic Studies, Biomed Chromatogr., 23(6) (2009) 568-572.
  • [18] Rao R.N, Bompelli S., Maurya P.K., High-Performance Liquid Chromatographic Determination of Anti-Hypertensive Drugs on Dried Blood Spots Using a Fluorescence Detector-Method Development and Validation, Biomed Chromatogr., 25(11) (2011) 1252-1259.
  • [19] Ferreirós N., Iriarte G., Alons R.M., Jiménez R.M., Development of a Solid Phase Extraction Procedure for HPLC-DAD Determination of Several Angiotensin II Receptor Antagonists in Human Urine using Mixture Design, Talanta, 73(4) (2007) 748-756.
  • [20] Hafez H.M., Elshanawane A.A., Abdelaziz L.M., Kamal M.M.Quantitative Determination of Three Angiotensin-II-Receptor Antagonists in Presence of Hydrochlorothiazide by RP-HPLC in their tablet preparations, Iranian J Pharm Res., 12 (2013) 635-643.
  • [21] Shakya A.K, Al-Hiari Y.M, Alhamami O.M.O., Liquid Chromatographic Determination of İrbesartan in Human Plasma, J Chromatogr B., 848(2) (2007) 245-50.
  • [22] Koyuturk S., Can N.O., 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., 97 (2014) 103-110.
  • [23] Vagamani M., Sahoo S.K., Kavitha D., Vagyalaxmi C.H., Mahapatra L., Validated RPHPLC Method for Simultaneous Estimation of Irbesartan and Hydrochlorothiazide in Tablet Dosage Form. Int J Pharm Res and Health Sci., 5 (2017) 1419-23.
  • [24] Rao K.T., Rao L.V., Kandepi K.M., Rapid Stability-indicating RRLC Method for Simultaneous Estimation of Irbesartan and its Related Impurities. Indian J Pharm Sci., 78 (2016) 252-58.
  • [25] Kissenger P.T., Heineman W.R., (Eds.), Laboratory Techniques in Electroanalytical Chemistry, 2nd Ed., Marcel Dekker, New York, (1996).
  • [26] The United States Pharmacopoeia, Thirtieth Revision, and The National Formulary, 25th ed., Rockville, USA, (2007) 1802-1805.
  • [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 (1996).
  • [28] El-Hefnawey G.B., El-Hallag I.S., Ghoneim E.M., Ghoneim M.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., 34 (2004) 75-86.
  • [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, International J Pharm., 111 (1994) 83-87.
  • [30] British Pharmacopoeia, The Stationary Office, London, (2003).
There are 30 citations in total.

Details

Primary Language English
Subjects Pharmaceutical Analytical Chemistry
Journal Section Natural Sciences
Authors

Bilal Yılmaz 0000-0002-8574-7570

Publication Date June 30, 2025
Submission Date May 17, 2024
Acceptance Date April 2, 2025
Published in Issue Year 2025Volume: 46 Issue: 2

Cite

APA Yılmaz, B. (2025). Determination of Irbesartan in Pharmaceutical Preparations by HPLC. Cumhuriyet Science Journal, 46(2), 206-211. https://doi.org/10.17776/csj.1485381
 Download Cover Image