International Journal of Research in Pharmacy and Allied Science

ISSN: 2583-6544   |  Issues per year: Monthly  |   Indexed In: Google Scholar, CORE, ScienceOpen, Researchgate

ISSN:2583-6544

Abstract View

Comprehensive review on Alfuzosin quantification: Analytical techniques and the evolution of AQbD in method development

Author(s): Patlolla Pravalika1, Jaggayagari Sarika2, Panuganti Pranavi3, Kondam Rithikesh4, Tadikonda Rama Rao5

Email(s): 1pravalika.jntu@gmail.com

Address:

    Department of Pharmaceutical Analysis, CMR College of Pharmacy, Kandlakoya, Medchal, Hyderabad, Telangana, India.

Published In:   Volume - 4,      Issue - 6,     Year - 2025

DOI: https://doi.org/10.71431/IJRPAS.2025.4602  

 View HTML        View PDF

Please allow Pop-Up for this website to view PDF file.

ABSTRACT:
Alfuzosin is an alpha-adrenergic antagonist that is used in the treatment of benign prostatic hyperplasia. With a focus on spectroscopic and chromatographic techniques, this review critically examines the many analytical procedures developed for alfuzosin evaluation. The ease of use and minimal resource requirements of UV spectroscopic techniques have made them indispensable tools for routine quality control and early evaluations.In parallel, chromatographic methods particularly High-Performance Liquid Chromatography (HPLC) and the recently developed Ultra-Performance Liquid Chromatography (UPLC) systems have become the mainstay for quantifying alfuzosin in complex matrices due to their exceptional resolution, sensitivity, and specificity. Furthermore, the breadth of pharmacokinetic and bioequivalence investigations has expanded thanks to sophisticated hyphenated techniques like LC-MS/MS. Analytical Quality by Design (AQbD) concepts, which emphasize method robustness, lifecycle management, and systematic risk management, have brought about a paradigm change that is further explored in this paper. AQbD makes it easier to create techniques that are both optimal and comply with regulations by integrating tools such as multivariate analysis and Design of Experiments (DoE). This paper provides a thorough viewpoint for future technique development and validation for alfuzosin, highlighting the shift from conventional to contemporary, risk-based analytical strategies.

Keywords:

Cite this article:
Patlolla Pravalika, Jaggayagari Sarika, Panuganti Pranavi, Kondam Rithikesh, Tadikonda Rama Rao. Comprehensive review on Alfuzosin quantification: Analytical techniques and the evolution of AQbD in method development. IJRPAS, June 2025; 4 (6): 6-23.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2025.4602


1.      El-Brashy AM, El-Azazy MS, Salem MY. Direct spectrophotometric determination of alfuzosin in presence of degradation products. SpectrochimActa A MolBiomolSpectrosc.2020; 227:117669.

2.      Soliman SM, Abbas SS, Zaazaa HE, et al. First derivative spectrophotometric method for determination of alfuzosin amidst its degradation products. J Pharm Biomed Anal.2019; 172:119–125.

3.      Mohamed GG, Zayed MA, El-Maghrabey MH. Third derivative spectrophotometric analysis of alfuzosin hydrochloride in pharmaceutical preparations. Talanta.2018; 176:186–192.

4.      Abdelwahab NS, Abdelrahman MM, Tolba MM, et al. Native fluorescence method for the sensitive determination of alfuzosin in plasma using solid-phase extraction. Microchem J.2021; 167:106282.

5.      Darwish IA, Amer SM, Abdine HH, Al-Rayes LI. Selective determination of degradation products of alfuzosin via fluorescamine reaction. Anal Chem Lett. 2017;7(4):513–523.

6.      Fayed AS, Shehata MA, Hassan NY, El-Weshahy SA. Validated HPLC and HPTLC stability-indicating methods for determination of alfuzosin hydrochloride in bulk powder and pharmaceutical formulations. J Sep Sci. 2006; 29(17):2716–2724. doi:10.1002/jssc.200600220.

7.      M. Sindhura, K. Raghavi, R. Prashanthi, Buchi N. Nalluri. Simultaneous Estimation of Finasteride and Tamsulosin Hydrochloride in Combined Dosage Forms by RP-HPLC-PDA Method, J.App.Pharm.Sci. 2(6): 203-209, 2012.

8.      M.K. Thimmaraju, V. Rao, S. Gurrala, G. J. Reddy. UV spectrophotometric method for determination of finasteride in bulk and pharmaceutical dosage form, Int. J. Pharm. Biol. Sci. 1:39-43(2011).

9.      Basavaiah K, Somashekar.B.C. Determination of finasteride in Tablets by High Performance Liquid Chromatography, E-Journal of Chemistry. 4: 109 116(2007).

10.  I.B. Mohammed, P.K. Vanitha, H.C. Kumar, U.G. Rani, P. Ramakrishna. Colorimetric Determination of Alfuzosin HCl in Pharmaceutical Formulations, journal of pharmacy research, 4:226(2011).

11.  B.S.K. Kumar, A.V. Ranjani, D. Sathyavathi. New RP-HPLC method development and validation for assay of alfuzosin hydrochloride in tablet dosage form. Int J Pharm PharmSci, 2: 90-92(2010).

12.  D.B. Patel, N.J. Patel. Development and validation of reverse phase high performance liquid chromatography and high performance thin layer chromatography methods for estimation of alfuzosin hydrochloride in bulk and in pharmaceutical formulations, Int J Chem Tech Res,1(4) :985 990,2009.

13.    Bebawy LI, Abbas SS, Fattah LA, Refaat HH. Spectrophotometric methods for the determination of Alfuzosin hydrochloride in pure and dosage forms. J AOAC Int. 2005;88(5):1380–6.

14.  Sharma MC, Sharma S, Kohli DV. UV Spectrophotometric method for estimation of Alfuzosin hydrochloride in bulk and tablets. Int J ChemTech Res. 2010; 2(1):292–5.

15.   El-Bagary RI, Elkady EF, Ayoub BM. Liquid chromatographic determination of Alfuzosin hydrochloride in pharmaceutical preparations. Talanta. 2009; 79(4):1043–7.

16.  Darwish IA, Alzoman NZ, Al-Tamimi SA, Abdel-Rahman HM. Development and validation of spectrofluorimetric method for determination of Alfuzosin hydrochloride in pharmaceutical preparations and human plasma. Luminescence. 2013;28(5):670–6.

17.    Patel PB, Patel MR, Patel KR, Patel NM. Development and validation of derivative spectrophotometric method for determination of Alfuzosin hydrochloride in bulk and tablet dosage form. J Pharm SciBiosci Res. 2011;1(2):81–5.

18.  Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol. 2009;27(1):26–34.

19.   Swartz ME. Analytical quality by design (AQbD) in pharmaceutical development. Am Pharm Rev. 2010;13(3):56–63.

20.  Kumar S, Bhardwaj SK. A review: HPLC method development and validation. Int J Pharm Sci Res. 2015;6(9):4103–12.

21.  Gandhi SV, Habde AB. Development and validation of chemometric-assisted UV-Vis spectrophotometric methods for simultaneous estimation of drugs in pharmaceutical dosage forms. Int J Pharm Sci Res. 2017;8(5):2050–7.

22.  Patil P, Patil V, Patil S. Analytical QbD: Development of a native gel electrophoresis method for measurement of monoclonal antibody aggregates. Electrophoresis. 2014;35(7):1002–9.

23.   Sharma MC, Sharma S, Kohli DV. UV spectrophotometric method for estimation of Alfuzosin hydrochloride in bulk and tablets. Int J ChemTech Res. 2010;2(1):292–5.

24.   International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Harmonised Guideline: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development. 2022.

25.  Tom J. UV-Vis Spectroscopy: Principle, Strengths and Limitations and Applications. Technology Networks. Published October 5, 2021. Accessed May 3, 2025. Available from.

26.   El-Gindy A, Abdel-Salam RA, Hadad GM. Development and validation of stability-indicating spectrophotometric methods for determination of alfuzosin hydrochloride. J Pharm Biomed Anal. 2018; 150:345–352.

27.   Kumar V, Singh R. Native fluorescence spectroscopy for selective estimation of alfuzosin in plasma. Anal Chim Acta. 2020; 1105:72–78.

28.  Sharma R, Patel B. A validated third-derivative spectrophotometric method for alfuzosin estimation. Indian J Pharm Sci. 2019; 81(2):305–310.

29.  Kamila MM, Mondal N, Ghosh LK, Gupta BK. Spectrophotometric determination of alfuzosin HCl in pharmaceutical formulations with some chromogenic reagents. Int J Pharm Sci. 2007; 69(1):145-148.

30.  Rahman N, Azmi SNH. Kinetic spectrophotometric method for the determination of alfuzosin in pharmaceutical formulations. Anal Sci. 2005;21(12):1493-1498. doi:10.2116/analsci.21.1493doi:10.2116/analsci.21.1493

31.  Prabhakar G, Giridhar R. Simple and sensitive UV spectrophotometric method for alfuzosin hydrochloride in bulk and pharmaceutical dosage forms. Indian J Pharm Sci. 2002;64(5):489-491.

32.  El-Wasseef DR, El-Sherbiny DT, Eid M, Belal F. Spectrophotometric determination of alfuzosin HCl through diazotization and coupling reactions. J Pharm Biomed Anal. 2008;48(3):1011-1016. doi: 10.1016/j.jpba.2008.07.021

33.  Patel DB, Patel NJ, Prajapati AM. First derivative spectrophotometric method for the simultaneous estimation of alfuzosin and finasteride in pharmaceutical dosage form. Int J Pharm Res. 2010;2(3):45-50.

34.  Basavaiah K, Anil Kumar UR. Spectrophotometric determination of alfuzosin in pharmaceutical formulations using chromogenic reagents. Indian J Chem Technol. 2007;14(6):611-616.

35.  Rajendra prasad N, Basavaiah K. Sensitive spectrophotometric determination of alfuzosin hydrochloride in pharmaceuticals through diazotization. J Anal Chem. 2010;65(8):849-855. doi:10.1134/S106193481008013Xdoi:10.1134/S106193481008013X

36.  Lotfy HM, Saleh SS, El-Bayoumi AA. Green spectrophotometric methods for the determination of alfuzosin and solifenacin in binary mixture. J AOAC Int. 2019;102(4):1234-1242. doi:10.5740/jaoacint.18-0392doi:10.5740/jaoacint.18-0392

37.  Attia KAM, El-Abasawi NM, El-Olemy A, Serag A. Different spectrophotometric methods for simultaneous determination of tadalafil and alfuzosin in pharmaceutical dosage form. Spectrochim Acta A Mol Biomol Spectrosc. 2016; 152:149-155. doi: 10.1016/j.saa.2015.07.067

38.  Skoog DA, West DM, Holler FJ, Crouch SR. Fundamentals of Analytical Chemistry. 9th ed. Belmont, CA: Cengage Learning; 2013.

39.  Skoog DA, Holler FJ, Nieman TA. Principles of Instrumental Analysis. 6th ed. Belmont, CA: Thomson Brooks/Cole; 2006.

40.  Chatwal GR, Anand SK. Instrumental Methods of Chemical Analysis. Mumbai: Himalaya Publishing House; Latest ed.

41.  Braithwaite A, Smith JF. Chromatographic Methods. 5th ed. London: Springer; 1995.

42.  Gupta MN, Menghani E. Introduction to Kinetics and Mechanism of Chemical Reactions. Hyderabad: Universities Press; 2009.

43.  International Conference on Harmonisation (ICH). ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology. 2005

Related Images:



Recent Images



Neurological Complications among Pregnant and Post Partum Mothers in a Private Hospital, Yogyakarta, Indonesia
Review on Regulatory Affairs in Pharmaceutical Industry
Cucumber and Mint Soap: Preparation and Evaluation
Topical Delivery in Cosmetics: Enhancing Penetration and Bioavailability
Formulation and Evaluation of Polyherbal Soap
Gelatin: A Widely Used Pharmaceutical Excipient
Therapeutic insights into Saroglitazar: a dual PPAR- α/γ agonist targeting diabetic dyslipidaemia and NAFLD
A Comprehensive Review on Dyslipidemia and Obesity: Pathophysiology, Clinical Implications and Management Approaches
Antidiabetic Herbs and Polyherbal Antidiabetic Formulations –An Overview
Review on Clinical Research and Clinical Trials

Tags


Quick Links


Latest Issues

Popular Articles