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In the last few years, the use of surfactants as mobile phase additives in reversed phase liquid chromatography (RPLC) has been steadily developing and improving. Surfactants modify the polarity of the stationary phase which in turn decreases the amount of organic solvent required for elution of the analytes rendering the methodologies linked to them greener and more eco-friendly. Brij-35 is a fatty alcohol ethoxylates non ionic surfactant, which is less widely used as mobile phase additive. Brij-35 can decrease stationary phase polarity while remaining neutral. In this research, Brij-35 was studied in the separation and determination of marketed antihypertensive combination therapy composed of triamterene (TRM) and xipamide (XIP). TRM and XIP are diuretics used for treatment of essential hypertension and associated edema conditions. Chromatographic separation was achieved on RP-C18 column (Kinetix®, 5 mm, 15 cm 3 4.6 mm) at flow rate 1 mL min1 and UV-detection at 254 nm. Isocratic elution was performed using mobile phase composed of 0.1 M Brij-35: methanol (MeOH) (60:40, v/v). The analytes were well separated and quantified within linearity ranges of 5–50 mg mL1 for both drugs in short retention time (2.6 and 5.3 min. for TRM and XIP, respectively). Since claiming greenness is not enough, Green Analytical Procedure Index (GAPI) was used to demonstrate the superiority of the proposed method over the previously reported methods. GAPI is a new metric for evaluation of the ecological impact of analytical procedures. The proposed method was validated according to ICH guidelines and applied successfully for simultaneous determination of the drugs in their co-formulated tablets.
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Czasopismo
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Tom
Strony
51--56
Opis fizyczny
Bibliogr. 24 poz., rys., tab.
Twórcy
autor
- Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Egypt
autor
- Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Egypt
autor
- Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Port-Said University, Egypt
autor
- Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Egypt
autor
- Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, MansouraUniversity, Egypt
Bibliografia
- 1. El-Shaheny, R. N.; El-Maghrabey, M. H.; Belal, F. F. Micellar liquid chromatography from green analysis perspective. Open Chem. 2015, 13(1), 887–92.
- 2. Ibrahim, A. E.; Saleh, H.; Elhenawee, M. Assessment and validation of green stability indicating RP-HPLC method for simultaneous determination of timolol and latanoprost in pharmaceutical dosage forms using eco-friendly chiral mobile phase. Microchem. J. 2019, 148, 21–6.
- 3. Chang, Y.-T.; Hung, C.-H.; Chou, H.-L. Effects of polyethoxylate lauryl ether (Brij 35) addition on phenanthrene biodegradation in a soil/water system. J. Environ. Sci. Health, Part A. 2014, 49(14), 1672–84.
- 4. Miller, U.; Sówka, I.; Adamiak, W. In The Application of Brij 35 in Biofiltration of the Air Polluted with Toluene Vapours, E3S Web of Conferences, EDP Sciences, 2018; p 00113.
- 5. Sweetman, S. Martindale–The Complete Drug Reference, 36th ed.; Pharmaceutical Press: London, 2009.
- 6. Jiménez Girón, A.; Deventer, K.; Roels, K.; Van Eenoo, P. Development and validation of an open screening method for diuretics, stimulants and selected compounds in human urine by UHPLC–HRMS for doping control. Anal. Chimica Acta. 2012, 721, 137–146.
- 7. Ventura, R.; Roig, M.; Monfort, N.; Sáez, P.; Bergés, R.; Segura, J. High-throughput and sensitive screening by ultra-performance liquid chromatography tandem mass spectrometry of diuretics and other doping agents. Eur. J. Mass Spec. 2008, 14(3), 191–200.
- 8. Thörngren, J. O.; Östervall, F.; Garle, M. A high‐throughput multicomponent screening method for diuretics, masking agents, central nervous system (CNS) stimulants and opiates in human urine by UPLC–MS/MS. J. Mass Spec. 2008, 43(7), 980–992.
- 9. Thieme, D.; Grosse, J.; Lang, R.; Mueller, R.; Wahl, A. Screening, confirmation and quantitation of diuretics in urine for doping control analysis by high-performance liquid chromatography– atmospheric pressure ionisation tandem mass spectrometry. J. Chrom. B: Biomed. Sci. Appl. 2001, 757(1), 49–57.
- 10. Qin, Y.; Wang, X.; Wang, C.; Zhao, M.; Wu, M.; Xu, Y.; Peng, S. Application of high-performance liquid chromatography–mass spectrometry to detection of diuretics in human urine. J. Chrom. B. 2003, 794(1), 193–203.
- 11. Goebel, C.; Trout, G. J.; Kazlauskas, R. Rapid screening method for diuretics in doping control using automated solid phase extraction and liquid chromatography-electrospray tandem mass spectrometry. Anal. Chimica Acta. 2004, 502(1), 65–74.
- 12. De Wilde, L.; Roels, K.; Polet, M.; Van Eenoo, P.; Deventer, K. Identification and confirmation of diuretics and masking agents in urine by turbulent flow online solid-phase extraction coupled with liquid chromatography-triple quadrupole mass spectrometry for doping control. J. Chrom. A. 2018, 1579, 31–40.
- 13. Görgens, C.; Guddat, S.; Thomas, A.; Wachsmuth, P.; Orlovius, A.-K.; Sigmund, G.; Thevis, M.; Schänzer, W. Simplifying and expanding analytical capabilities for various classes of doping agents by means of direct urine injection high performance liquid chromatography high resolution/high accuracy mass spectrometry. J. Pharm. Biomed. Anal. 2016, 131, 482–496.
- 14. Ibrahim, A. E.; Saraya, R. E.; Saleh, H.; Elhenawee, M. Development and validation of eco-friendly micellar-HPLC and HPTLC-densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms. Heliyon. 2019, 5(4), e01518.
- 15. Rosado-Maria, A.; Gasco-Lopez, A.; Santos-Montes, A.; Izquierdo-Hornillos, R. High-performance liquid chromatographic separation of a complex mixture of diuretics using a micellar mobile phase of sodium dodecyl sulphate: application to human urine samples. J. Chrom. B: Biomed. Sci. Appl. 2000, 748(2), 415–24.
- 16. Ruiz-Angel, M.; Torres-Lapasió, J.; Garcıa-Alvarez-Coque, M. Effects of pH and the presence of micelles on the resolution of diuretics by reversed-phase liquid chromatography. J. Chrom. A. 2004, 1022(1–2), 51–65.
- 17. Maher, H. M.; Youssef, R. M.; Eman, I.; Hassan, E. M.; Barary, M. A. Bioavailability study of triamterene and xipamide using urinary pharmacokinetic data following single oral dose of each drug or their combination. J. Pharm. Biomedi. Anal. 2012, 61, 78–85.
- 18. El-Kimary, E. I. Stability-indicating HPLC-DAD method development, validation, and stress degradation studies for triamterene and xipamide in their combined tablet dosage form. Acta Chrom. 2016, 28(1), 79–98.
- 19. El-Hay, S. S. A.; Hashem, H.; Gouda, A. A. High performance liquid chromatography for simultaneous determination of xipamide, triamterene and hydrochlorothiazide in bulk drug samples and dosage forms. Acta Pharm. 2016, 66(1), 109–18.
- 20. Wagieh, N. E.; Abbas, S. S.; Abdelkawy, M.; Abdelrahman, M. M. Spectrophotometric and spectrodensitometric determination of triamterene and xipamide in pure form and in pharmaceutical formulation. Drug Test. Anal. 2010, 2(3), 113–21.
- 21. Nassar, M. W.; Attia, K. A.; Mohamad, A. A.; Said, R. A.; Abdel-Monem, A. H. Simultaneous spectrophotometric estimation of triamterene and xipamide in pure form and pharmaceutical formulation by iso-absorptive point dependent methods. Anal. Chem. Lett. 2017, 7(6), 792–804.
- 22. ICH, Guidelines. Validation of Analytical Procedures: Text and Methodology Q2 (R1); International Conference on Harmonization: Geneva, Switzerland, 2005; pp 11–2.
- 23. Gałuszka, A.; Migaszewski, Z. M.; Konieczka, P.; Namieśnik, J. Analytical eco-scale for assessing the greenness of analytical procedures. TrAC Trends Anal. Chem. 2012, 37, 61–72.
- 24. Płotka-Wasylka, J. A new tool for the evaluation of the analytical procedure: Green Analytical Procedure Index. Talanta. 2018, 181, 204–9.
Uwagi
Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2021).
Typ dokumentu
Bibliografia
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