Simultaneous Determination of Irbesartan and Hydrochlorothiazide in Tablets by CE-DAD
Year 2015,
Volume: 43 Issue: 3, 145 - 152, 01.09.2015
Arin Gül Dal
Sema Koyutürk
Abstract
Acapillary electrophoretic method was developed and validated for the simultaneous determination of irbesartan and hydrochlorothiazide in tablets. The run buffer was used 10 mM borate buffer containing 10% methanol pH 9.0 . Compounds were separated less than 6 minutes. The limit of quantification LOQ values were 3.370×10-7 M 0.144 μg/mL and 3.140×10-7 M 0.094 μg/mL for irbesartan and hydrochlorothiazide, respectively. The method was applied successfully to both irbesartan and irbesartan/hydrochlorothiazide combi- ned tablets with good recoveries almost 100%.
References
- 1. M. Burnier, H.R. Brunner, Angiotensin II receptor antagonists, Lancet, 355 (2000), 637-345.
- 2. A. Lant, Diuretics. Clinical pharmacology and therapeutic use (Part II), Drugs, 29(2) (1985), 162-188.
- 3. I. Albero, V. Rodenas, S. Garcia, C. Sanchez-Pedreno, Determination of irbesartan in the presence of hydrochlorothiazide by derivative spectrophotometry, J. Pharm. Biomed. Anal., 29 (2002) 299-305.
- 4. N. Erk, Three new spectrophotometric methods applied to the simultaneous determination of hydrochlorothiazide and irbesartan, Pharmazie, 58 (2003) 543-548.
- 5. Y.M. Fayez, Simultaneous determination of some antihypertensive drugs in their binary mixture by novel spectrophotometric methods, Spectrochim. Acta, Part A: Mol. Biomol. Spectr., 132 (2014) 446–451.
- 6. J. Joseph-Charles, S. Brault, C. Boyer, M.-H. Langlois, L. Cabrero, J.-P. Dubost, Simultaneous Determination of Irbesartan and Hydrochlorothiazide in Tablets by Derivative Spectrophotometry, Anal. Lett., 36 (2003) 2485 -2495.
- 7. C. Vetuschi, A. Giannandrea, G. Carlucci, P. Mazzeo, Determination of hydrochlorothiazide and irbesartan in pharmaceuticals by fourth-order UV derivative spectrophotometry, Il Farmaco, 60 (2005) 665–670.
- 8. A.M. Alanazi, A.S. Abdelhameed, N.Y. Khalil, A.A. Khan, I.A. Darwish, HPLC method with monolithic column for simultaneous determination of irbesartan and hydrochlorothiazide in tablets, Acta Pharm., 64 (2014) 187–198.
- 9. F.Coudore, L. Harvard, S. Lefeuvre, E.M. Billaud, P. Beaune, G. Bobrie, M. Azizi, P. Prognon, S. Laurent, HPLC–DAD Analysis of Hydrochlorothiazide and Irbesartan in Hypertensive Patients on Fixed-Dose Combination Therapy, Chromatographia, 74 (2011) 559–565.
- 10. A.A. Elshanawane, L. M. Abdelaziz, M.M. Kamal, H.M. Hafez, Quantitative determination of four angiotensin-II receptor antagonists in presence of hydrochlorothiazide by a gradient technique HPLC in their pharmaceutical preparations, J. Liq. Chromatogr. Related Technol., 37 (2014) 171–186.
- 11. N. Erk, Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma by liquid chromatography, J. Chromatogr. B, 784 (2003) 195- 201.
- 12. H.M. Hafez, A.A. Elshanawane, L.M. Abdelaziz, M.M. Kamal, Quantitative Determination of three Angiotensin-II-receptor Antagonists in Presence of Hydrochlorothiazide by RP-HPLC in their Tablet Preparations, Iranian J. Pharma. Res., 12 (2013) 635- 643.
- 13. A.S. Khodke, L.V. Potale, M.C. Damle, K.G. Bothara, A validated stability indicating HPTLC method for simultaneous estimation of irbesartan and hydrochlorothiazide, Pharm. Methods, 2(1) (2010) 39- 43.
- 14. S. Koyutürk, N. Ö. Can, Z. Atkoşar, G. Arlı., 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.
- 15. X. Qiu, Z. Wang, B. Wang, H. Zhan, X. Pan, R. Xu, 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, 957 (2014) 110-115.
- 16. L.F. Tutunji, M.F. Tutunji, M.I. Alzoubi, M.H. Khabbas, A.I. Arida, Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma using HPLC coupled with tandem mass spectrometry: Application to bioequivalence studies, J. Pharm. Biomed. Anal., 51 (2010) 985-990.
- 17. Z. Vujic, N. Mulavdic, M. Smajic, J. Brboric, P. Stankovic, Simultaneous Analysis of Irbesartan and Hydrochlorothiazide:An Improved HPLC Method with the Aid of a Chemometric Protocol, Molecules, 17 (2012) 3461-3474.
- 18. R. Zhang, X. Chen, Q. Li, W. Liu, W. Yang, K. Bi, L. Sun, Liquid chromatography coupled with mass spectrometry method for the simultaneous quantification of irbesartan and hydrochlorothiazide in human plasma, J. Chin. Pharm. Sci., 20 (2011) 360– 367.
- 19. S. Hillaert, W. Van den Boosche, Simultaneous determination of hydrochlorothiazide and several angiotensin-II-receptor antagonists by capillary electrophoresis, J. Pharm. Biomed. Anal., 31 (2003) 329-339.
- 20. ICH, Q2(R1), Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology in International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, (2005).
İrbesartan ve Hidroklorotiyazidin CE-DAD ile Tabletlerden Eşzamanlı Miktar Tayin
Year 2015,
Volume: 43 Issue: 3, 145 - 152, 01.09.2015
Arin Gül Dal
Sema Koyutürk
Abstract
İ rbesartan ve hidroklorotiazidin tabletlerde eş zamanlı analizi için bir elektroforetik yöntem geliştirilmiştir. %10 metanol içeren 10 mM borat pH 9.0 çalışma tamponu olarak kullanılmıştır. Bileşikler 6 dakikadan daha düşük sürede ayrılmıştır. Tayin sınırı LOQ değerleri irbesartan için 3.370×10-7 M 0.144 µg/mL ve hidroklorotiazid için 3.140×10-7 M 0.094 µg/mL ’dir. Yöntem, irbesartan ve irbesartan/hidroklorotiazidi birlikte içeren tabletlere yaklaşık %100 gibi bir geri kazanımla başarılı bir şekilde uygulanmıştır
References
- 1. M. Burnier, H.R. Brunner, Angiotensin II receptor antagonists, Lancet, 355 (2000), 637-345.
- 2. A. Lant, Diuretics. Clinical pharmacology and therapeutic use (Part II), Drugs, 29(2) (1985), 162-188.
- 3. I. Albero, V. Rodenas, S. Garcia, C. Sanchez-Pedreno, Determination of irbesartan in the presence of hydrochlorothiazide by derivative spectrophotometry, J. Pharm. Biomed. Anal., 29 (2002) 299-305.
- 4. N. Erk, Three new spectrophotometric methods applied to the simultaneous determination of hydrochlorothiazide and irbesartan, Pharmazie, 58 (2003) 543-548.
- 5. Y.M. Fayez, Simultaneous determination of some antihypertensive drugs in their binary mixture by novel spectrophotometric methods, Spectrochim. Acta, Part A: Mol. Biomol. Spectr., 132 (2014) 446–451.
- 6. J. Joseph-Charles, S. Brault, C. Boyer, M.-H. Langlois, L. Cabrero, J.-P. Dubost, Simultaneous Determination of Irbesartan and Hydrochlorothiazide in Tablets by Derivative Spectrophotometry, Anal. Lett., 36 (2003) 2485 -2495.
- 7. C. Vetuschi, A. Giannandrea, G. Carlucci, P. Mazzeo, Determination of hydrochlorothiazide and irbesartan in pharmaceuticals by fourth-order UV derivative spectrophotometry, Il Farmaco, 60 (2005) 665–670.
- 8. A.M. Alanazi, A.S. Abdelhameed, N.Y. Khalil, A.A. Khan, I.A. Darwish, HPLC method with monolithic column for simultaneous determination of irbesartan and hydrochlorothiazide in tablets, Acta Pharm., 64 (2014) 187–198.
- 9. F.Coudore, L. Harvard, S. Lefeuvre, E.M. Billaud, P. Beaune, G. Bobrie, M. Azizi, P. Prognon, S. Laurent, HPLC–DAD Analysis of Hydrochlorothiazide and Irbesartan in Hypertensive Patients on Fixed-Dose Combination Therapy, Chromatographia, 74 (2011) 559–565.
- 10. A.A. Elshanawane, L. M. Abdelaziz, M.M. Kamal, H.M. Hafez, Quantitative determination of four angiotensin-II receptor antagonists in presence of hydrochlorothiazide by a gradient technique HPLC in their pharmaceutical preparations, J. Liq. Chromatogr. Related Technol., 37 (2014) 171–186.
- 11. N. Erk, Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma by liquid chromatography, J. Chromatogr. B, 784 (2003) 195- 201.
- 12. H.M. Hafez, A.A. Elshanawane, L.M. Abdelaziz, M.M. Kamal, Quantitative Determination of three Angiotensin-II-receptor Antagonists in Presence of Hydrochlorothiazide by RP-HPLC in their Tablet Preparations, Iranian J. Pharma. Res., 12 (2013) 635- 643.
- 13. A.S. Khodke, L.V. Potale, M.C. Damle, K.G. Bothara, A validated stability indicating HPTLC method for simultaneous estimation of irbesartan and hydrochlorothiazide, Pharm. Methods, 2(1) (2010) 39- 43.
- 14. S. Koyutürk, N. Ö. Can, Z. Atkoşar, G. Arlı., 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.
- 15. X. Qiu, Z. Wang, B. Wang, H. Zhan, X. Pan, R. Xu, 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, 957 (2014) 110-115.
- 16. L.F. Tutunji, M.F. Tutunji, M.I. Alzoubi, M.H. Khabbas, A.I. Arida, Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma using HPLC coupled with tandem mass spectrometry: Application to bioequivalence studies, J. Pharm. Biomed. Anal., 51 (2010) 985-990.
- 17. Z. Vujic, N. Mulavdic, M. Smajic, J. Brboric, P. Stankovic, Simultaneous Analysis of Irbesartan and Hydrochlorothiazide:An Improved HPLC Method with the Aid of a Chemometric Protocol, Molecules, 17 (2012) 3461-3474.
- 18. R. Zhang, X. Chen, Q. Li, W. Liu, W. Yang, K. Bi, L. Sun, Liquid chromatography coupled with mass spectrometry method for the simultaneous quantification of irbesartan and hydrochlorothiazide in human plasma, J. Chin. Pharm. Sci., 20 (2011) 360– 367.
- 19. S. Hillaert, W. Van den Boosche, Simultaneous determination of hydrochlorothiazide and several angiotensin-II-receptor antagonists by capillary electrophoresis, J. Pharm. Biomed. Anal., 31 (2003) 329-339.
- 20. ICH, Q2(R1), Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology in International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, (2005).