Rahul D. Rathod, Vikas R. Patil, Kuldip R. Patil, Pawan I. Naik, Sopan Nangare
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Rahul D. Rathod1, Vikas R. Patil2*, Kuldip R. Patil3, Pawan I. Naik2, Sopan Nangare4
1QA Chemist, ICPA Health Products LTD., Ankleshwar- 393002, Gujrat, India.
2Assistant Professor, Department of Pharmaceutical Chemistry, TSPM’s, Trimurti Institute of Pharmacy,
Paldhi (Bk) - 425103, Dist. Jalgaon (MS), India.
3Assistant Professor, Department of Pharmaceutics, TSPM’s, Trimurti Institute of Pharmacy,
Paldhi (Bk) - 425103, Dist. Jalgaon (MS), India.
4Assistant Professor, Department of Pharmaceutics, H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur - 425405 Dist. Dhule (MS) India.
Volume - 12,
Issue - 1,
Year - 2022
Ambrisentan (AMB) belongs to the class of an antihypertensive drug. Generally, it is used to treat pulmonary arterial hypertension. It is a non-peptide, highly selective endothelin-1 antagonist of type A receptor. Herein, endothelin is the peptide that connects blood vessels and raises blood pressure (BP). In this case, AMB decreases blood pressure by inhibiting the effects of endothelin-1. As per literature, AMB was approved by the United States of food and drug administration (USFDA) in 2007. From its inception, there is several formulations are available in the market. Overall, there is a huge need to collect the analytical data reported by researchers owing to the major importance of AMB. Therefore, in the present review article, we have enlisted different analytical methods such as Ultraviolet (UV) visible spectroscopy, high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), and liquid-chromatography-mass spectroscopy methods (LC-MS) for both qualitative and quantitative analysis of AMB in pharmaceutical and biologicals. In the future, this review article will assist researchers regarding the development of a new analytic method for AMB.
Cite this article:
Rahul D. Rathod, Vikas R. Patil, Kuldip R. Patil, Pawan I. Naik, Sopan Nangare. A Concise Review on Analytical Profile of Ambrisentan. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):56-0. doi: 10.52711/2231-5675.2022.00011
Rahul D. Rathod, Vikas R. Patil, Kuldip R. Patil, Pawan I. Naik, Sopan Nangare. A Concise Review on Analytical Profile of Ambrisentan. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):56-0. doi: 10.52711/2231-5675.2022.00011 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-1-11
1. Frampton JE. Ambrisentan. American Journal of Cardiovascular Drugs. 2011; 11(4): 215-226.
2. Galiè N. Manes A. Branzi A. The endothelin system in pulmonary arterial hypertension. Cardiovascular Research. 2004; 61: 227–237.
3. Farber HW. Loscalzo J. Pulmonary arterial hypertension. New England Journal of Medicine. 2004; 351: 1655-1665.
4. Robyn JB. A review of pulmonary arterial hypertension: role of ambrisentan. Vascular Health and Risk Management. 2007; 3 (1): 11-22.
5. Kumar NS, Rani AP, Visalakshi T, Sekharan CB. Extractive spectrophotometric determination of ambrisentan. Advanced Pharmaceutical Bulletin. 2013; 3(1): 231-237.
6. Siddiqui MR, AlOthman ZA, Rahman N. Analytical techniques in pharmaceutical analysis: A review. Arabian Journal of Chemistry. 2017; 10: S1409-S1421.
7. Yunoos M, Lavanya NSL, Sravani G, Rao PM, Krishna C. Research article development of a validated UV spectrophotometric method for the estimation of ambrisentan in pure and marketed formulations. Scholars Academic Journal of Pharmacy. 2014; 3(6): 427-431
8. Venkata SBS, Venkata SPV, Sekaran CB. Validated stability indicating high performance liquid chromatographic method for the determination of ambrisentan in pharmaceutical dosage form. Pharmaceutical Scieneces. 2014; 9 (4): 109-115.
9. Balakrishna M, Unnisa A, Reddy P, Suma CH. RP-HPLC-PDA method for the analysis of ambrisentan in bulk drug and pharmaceutical dosage forms. International Journal of Chemical and Pharmaceutical Sciences. 2013; 4(4): 45-50.
10. Narayana MBV, Chandrasekhar KB, Rao BM. A validated specific stability-indicating RP-HPLC assay method for ambrisentan and its related substances. Journal of Chromatographic Science. 2014; 52(8): 818-825.
11. Satheeshkumar N, Naveenkumar G. A stability-indicating reversed-phase high-performance liquid chromatography method for ambrisentan: an endothelin receptor antagonist. Journal of Chromatographic Science. 2014; 52(8):894-898.
12. Karthikeyan R, Koushik OS, Babu PS. Simple validated RP-HPLC method for estimation of ambrisentan in pharmaceutical dosage forms. International Bulletin of Drug Research. 2015; 5(9): 1-18.
13. Nazeerunnisa M, Garikapati L, Bethanabhatla SS. Development and validation of a stability-indicating RP-HPLC method for determination of ambrisentan in bulk drugs. Malaysian Journal of Analytical Sciences. 2015; 19(3):595-602.
14. Sai SM, Yasawini P, Nazma SK, Sai SM, Lakshmi SG, Vijaya LM, Nalluri BN. Development and validation of RP-HPLC-PDA method for the estimation of ambrisentan in bulk and tablet dosage forms. Indian Drugs. 2016; 53(5): 43/47.
15. Kondila SK, Sujana K, Prameela RA. Development and validation of a stability-indicating RP-HPLC method for estimation of ambrisentan and its process-related impurities in bulk and pharmaceutical dosage forms. Indian Drugs. 2015. 52 (12) 34-41.
16. Singla RK, Chandu BR. Design of experiment assisted UV-visible spectrophotometric and RP-HPLC method development for ambrisentan estimation in bulk and formulations. World Journal of Analytical Chemisry. 2014. 2(2): 23-30.
17. Patel JK, Patel NK. Stability-indicating RP-HPLC method for the determination of ambrisentan and tadalafil in pharmaceutical dosage form. Scientia pharmaceutica. 2014; 82(4):749-764.
18. Kofman J, Zhao Y, Maloney T, Baumgartner T, Bujalski R. Ultra-high performance liquid chromatography: hope or hype? American Pharmaceutical Review. 2006; 9(3): 90-93.
19. Jerkovich AD, Mellors JS, Jorgenson JW. The use of micrometer-sized particles in ultrahigh pressure liquid chromatography. LC GC North America. 2003; 21 (7): 600-611.
20. Wu N, Lippert JA, Lee ML. Practical aspects of ultrahigh pressure capillary liquid chromatography. Journal of Chromatography A. 2001; 911 (1): 1-12.
21. Unger KK, Kumar D, Grun M, Buchel G, Ludtke S, Adam T, Schumacher K, Renker S. Practical aspects of fast reversed-phase high-performance liquid chromatography using 3 μm particle packed columns and monolithic columns in pharmaceutical development and production working under current good manufacturing practice. Journal of Chromatography A. 2004; 1036 (2): 127-133.
22. Swartz ME, Murphy BJ. Ultra performance liquid chromatography: Tomorrow’s HPLC technology today. Lab Plus International. 2004; 18(3): 6-9.
23. Kumar A, Saini G, Nair A, Sharma R. UPLC: A preeminent technique in pharmaceutical analysis. Acta Poloniae Pharmaceutica- Drug Research. 2012; 69(3): 371-380.
24. Zhang Y, Wu DR, Wang-Iverson DB, Tymiak AA. Enantioselective chromatography in drug discovery. Drug Discovery Today. 2005; 10 (8): 571-577.
25. Workman P. How much gets there and what does it do?: The need for better pharmacokinetic and pharmacodynamic endpoints in contemporary drug discovery and development. Current Pharmaceutical Design. 2003; 9(11): 891-902.
26. Swartz ME. UPLC™: an introduction and review. Journal of Liquid Chromatography & Related Technologies. 2005; 28(7-8): 1253-1263.
27. Ortigara R, Steppe M, Garcia CV. Stability-indicating UPLC-PDA method for ambrisentan tablets and identification of a main degradation product by UPLC-MS/MS. Current Pharmaceutical Analysis. 2020; 16(1): 55-63.
28. Garcia-Martínez S, Rico E, Casal E, Grisaleña A, Alcaraz E, King N, Leal N, Navarro I, Campanero MÁ. Bionalytical validation study for the determination of unbound ambrisentan in human plasma using rapid equilibrium dialysis followed by ultra-performance liquid chromatography coupled to mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis. 2018; 150: 427-435.
29. Van de Velde D, Bahmany S, Hitzerd E, van Domburg B, Versmissen J, Danser AJ, And Koch BC. Simultaneous quantification of ambrisentan, macitentan and sitaxentan in human plasma using UPLC–MS/MS. Biomedical Chromatography. 2020; 34(3): e4787.
30. Edmonds CG, McCloskey JA, Edmonds VA. A bibliography of combined liquid chromatography mass spectrometry. Biomedical Mass Spectrometry. 1983; 10 (4): 237-252.
31. Games DE. High-performance liquid chromatography/mass spectrometry (HPLC/MS). Advances in Chromatography (New York, NY). 1983; 21: 1-39.
32. Arpino PJ. Ten years of liquid chromatography-mass spectrometry. Journal of Chromatography A. 1985; 323 (1): 3-11.
33. Talroze VL, Skurat VE, Karpov GV. Application of a mass spectrometer with a capillary inlet system as a detector in a liquid chromatography. Russian Journal of Physical Chemistry, USSR. 1969; 43 (2): 241.
34. Nirogi R, Kandikere V, Komarneni P, Aleti R. Padala N, Kalaikadhiban I. LC-ESI-MS/MS method for quantification of ambrisentan in plasma and application to rat pharmacokinetic study. Biomedical Chromatography. 2012; 26(10): 1150-1156.
35. Ramisetti NR, Kuntamukkala R. LC-MS/MS characterization of forced degradation products of ambrisentan: development and validation of a stability-indicating RP-HPLC method. New Journal of Chemistry. 2014; 38(7): 3050-3061.