Recent Advances in Analytical Method Development and Validation for Simultaneous Estimation of Atorvastatin and Etoricoxib Using UV-Vis Spectrophotometry: A Comprehensive Review
DOI:
https://doi.org/10.52783/jns.v14.3204Keywords:
UV-Vis spectrophotometry, atorvastatin, etoricoxib, simultaneous estimation, pharmaceutical analysis,, multivariate calibrationAbstract
UV-Vis spectrophotometry functions as a popular analytical technique that pharmaceutical analysis adopts intensively for API quantity determination and formulation quality monitoring. This examination explores the application of UV-Vis spectrophotometry to simultaneously determine atorvastatin and etoricoxib which are pharmaceutical agents used in cardiovascular disease and inflammatory disorder treatment. Molecules inside complex mixtures can be measured using the absorption technique because the technique enables absorption of specific light wavelengths. Spectral wavelength overlaps create interference with excipients elements along with introducing matrix interferents thus posing difficulties to simultaneous estimation methods. A combination of derivative spectrophotometry techniques with both multivariate calibration and chemometric methods enhances the accuracy and sensitivity and precision of UV-Vis spectrophotometry measurements. The latest advancements in simultaneous analysis of atorvastatin along with etoricoxib in complicated pharmaceutical materials and biological specimens create precise and controlled determination methods. The advancement of UV-Vis spectrophotometry through research resulted in portable device and microfluidic system creation which enabled extended on-site analysis capabilities together with point-of-care testing potential. The review details the operation of this method throughout pharmaceutical quality controls and stability testing and bioequivalence examinations and bioanalytical work focused toward pharmaceutical product protection. Future developments in UV-Vis spectrophotometry will focus on improving detection sensitivity together with lowering interferences and enhancing mobility as part of green chemical methods and standardized analytical procedures worldwide. The future development agenda aims to strengthen UV-Vis spectrophotometry as an indispensable pharmaceutical analytical instrument.
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Davies JT, Delfino SF, Feinberg CE, Johnson MF, Nappi VL, Olinger JT, et al. Current and Emerging Uses of Statins in Clinical Therapeutics: A Review. Lipid Insights. 2016;9:13-29.
Burnett JR, Wilcox LJ, Telford DE, Kleinstiver SJ, Barrett PHR, Newton RS, et al. Inhibition of HMG-CoA Reductase by Atorvastatin Decreases Both VLDL and LDL Apolipoprotein B Production in Miniature Pigs. Arteriosclerosis, Thrombosis, and Vascular Biology. 1997;17(11):2589-600.
Martina SD, Vesta KS, Ripley TL. Etoricoxib: a highly selective COX-2 inhibitor. Ann Pharmacother. 2005;39(5):854-62.
Abdelwahab NS, El-Zeiny BA, Tohamy SI. Two spectrophotometric methods for simultaneous determination of some antihyperlipidemic drugs. Journal of Pharmaceutical Analysis. 2012;2(4):279-84.
Kang JS, Lee MH. Overview of therapeutic drug monitoring. Korean J Intern Med. 2009;24(1):1-10.
Alffenaar JC, Heysell SK, Mpagama SG. Therapeutic Drug Monitoring: The Need for Practical Guidance. Clin Infect Dis. 2019;68(6):1065-6.
Buschmann H, Handler N, Holzgrabe U. The quality of drugs and drug products – Always guaranteed? Journal of Pharmaceutical and Biomedical Analysis. 2024;239:115880.
Pearson RA, Wicha SG, Okour M. Drug Combination Modeling: Methods and Applications in Drug Development. J Clin Pharmacol. 2023;63(2):151-65.
Sharma S, Sharma MC. Development and validation of new analytical methods for simultaneous estimation of Drotaverine hydrochloride in combination with Omeprazole in a pharmaceutical dosage form. Arabian Journal of Chemistry. 2017;10:S397-S403.
El-Malla S, Kamal A, Hammad S. A review on UV spectrophotometric methods for simultaneous multicomponent analysis. European Journal of Pharmaceutical and Medical Research (EJPMR). 2016;3:348-60.
Chang SM, Matchar DB, Smetana GW, Umscheid CA, Gray R, Torchia M. Methods guide for medical test reviews. Rockville: Agency for Healthcare Research and Quality. 2012.
Payne RA, Avery AJ. Polypharmacy: one of the greatest prescribing challenges in general practice. Br J Gen Pract. 2011;61(583):83-4.
Hammond JP. Chapter 11 - The Use of Spectrophotometry in the Pharmaceutical Industry. In: Germer TA, Zwinkels JC, Tsai BK, editors. Experimental Methods in the Physical Sciences. 46: Academic Press; 2014. p. 409-56.
Derayea SM, Madian H, Samir E, Badr-eldin KM. Ecofriendly and smart spectrophotometric approaches for synchronized analysis of two antipsychotic drugs, fluoxetine and olanzapine: application to combined tablet dosages with assessment of method greenness. BMC Chemistry. 2025;19(1):38.
Loos G, Van Schepdael A, Cabooter D. Quantitative mass spectrometry methods for pharmaceutical analysis. Philos Trans A Math Phys Eng Sci. 2016;374(2079).
Panuwet P, Hunter RE, Jr., D'Souza PE, Chen X, Radford SA, Cohen JR, et al. Biological Matrix Effects in Quantitative Tandem Mass Spectrometry-Based Analytical Methods: Advancing Biomonitoring. Crit Rev Anal Chem. 2016;46(2):93-105.
Wang L, Yuan L, Pan L, Ji QC. Chapter 24 - Bioanalysis of biological matrix samples using liquid chromatography–tandem mass spectrometry detection. In: Riley CM, Rosanske TW, Reid G, editors. Specification of Drug Substances and Products (Second Edition): Elsevier; 2020. p. 641-59.
De Caro C, Claudia H. UV/Vis Spectrophotometry - Fundamentals and Applications2025.
Mandru A, Mane J, Mandapati R. A Review on UV-visible spectroscopy. Journal of Pharma Insights and Research. 2023;1(2):091-6.
Sudharshan N, Swetha V. UV-VISIBLE SPECTROSCOPY: A COMPREHENSIVE REVIEW ON INSTRUMENTATION. World J Pharm Res. 2023;12(19):1342-63.
Primer A. Fundamentals of UV-visible spectroscopy. Copyright Hewlett-Packard Company, Hewlett-Packard publication. 1996(12-5965).
Sinha S, Jeyaseelan C, Singh G, Munjal T, Paul D. Chapter 8 - Spectroscopy—Principle, types, and applications. In: Bhatt AK, Bhatia RK, Bhalla TC, editors. Basic Biotechniques for Bioprocess and Bioentrepreneurship: Academic Press; 2023. p. 145-64.
Østergaard J. UV/Vis Spectrophotometry and UV Imaging. In: Müllertz A, Perrie Y, Rades T, editors. Analytical Techniques in the Pharmaceutical Sciences. New York, NY: Springer New York; 2016. p. 3-27.
Sánchez Rojas F, Cano Pavón JM. SPECTROPHOTOMETRY | Biochemical Applications. In: Worsfold P, Townshend A, Poole C, editors. Encyclopedia of Analytical Science (Second Edition). Oxford: Elsevier; 2005. p. 366-72.
Burgess C. Chapter 2 - The basis for good spectrophotometric UV–visible measurements. In: Thomas O, Burgess C, editors. UV-Visible Spectrophotometry of Waters and Soils (Third Edition): Elsevier; 2022. p. 25-58.
Brown B, Ward A, Fazili Z, Østergaard J, Asare-Addo K. Application of UV dissolution imaging to pharmaceutical systems. Advanced Drug Delivery Reviews. 2021;177:113949.
L.C. Passos M, M.F.S. Saraiva ML. Detection in UV-visible spectrophotometry: Detectors, detection systems, and detection strategies. Measurement. 2019;135:896-904.
Pandey S, Pandey P, Tiwari G, Tiwari R. Bioanalysis in drug discovery and development. Pharm Methods. 2010;1(1):14-24.
Shinde KP, Rajmane AD. A review UV method development and validation. Asian Journal of Pharmaceutical Analysis. 2023;13(2):122-30.
30Mayuri D, Ravindranath S. Analytical Method Development and Validation: A Review. Journal of Drug Delivery & Therapeutics. 2019;9(3).
Patil M, Patil R, Chalikwar S, Surana S, Firke S. Analytical method development and validation: A review. International Journal of Pharmaceutical and Biological Science Archive. 2019;7(3).
Takemoto JK, Reynolds JK, Remsberg CM, Vega-Villa KR, Davies NM. Clinical pharmacokinetic and pharmacodynamic profile of etoricoxib. Clin Pharmacokinet. 2008;47(11):703-20.
Cerdà V, Phansi P, Ferreira S. From mono- to multicomponent methods in UV-VIS spectrophotometric and fluorimetric quantitative analysis – A review. TrAC Trends in Analytical Chemistry. 2022;157:116772.
Wang T, Zheng Y, Xu L, Yun Y-H. Comprehensive comparison on different wavelength selection methods using several near-infrared spectral datasets with different dimensionalities. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2025;331:125767.
Alruwaili NK. Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method. Int J Anal Chem. 2021;2021:8833900.
Kolář P, Shen J-W, Tsuboi A, Ishikawa T. Solvent selection for pharmaceuticals. Fluid Phase Equilibria. 2002;194-197:771-82.
Salehi N, Kuminek G, Al-Gousous J, Sperry DC, Greenwood DE, Waltz NM, et al. Improving Dissolution Behavior and Oral Absorption of Drugs with pH-Dependent Solubility Using pH Modifiers: A Physiologically Realistic Mass Transport Analysis. Mol Pharm. 2021;18(9):3326-41.
Stielow M, Witczyńska A, Kubryń N, Fijałkowski Ł, Nowaczyk J, Nowaczyk A. The Bioavailability of Drugs-The Current State of Knowledge. Molecules. 2023;28(24).
Kanu AB. Recent developments in sample preparation techniques combined with high-performance liquid chromatography: A critical review. Journal of Chromatography A. 2021;1654:462444.
Yarborough V, Haskin J, Lambdin W. Temperature dependence of absorbance in ultraviolet spectra of organic molecules. Analytical Chemistry. 1954;26(10):1576-8.
Lotfy HM, El-Hanboushy S, Fayez YM, Abdelkawy M. Spectral analysis of overlapped absorption bands of binary mixtures—an application on combination of pseudoephedrine sulphate and loratadine mixture. Future Journal of Pharmaceutical Sciences. 2019;5:1-14.
Lotfy HM, Saleh SS, Hassan NY, Salem H. Novel two wavelength spectrophotometric methods for simultaneous determination of binary mixtures with severely overlapping spectra. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2015;136:1786-96.
Chen HY, Chen C. Evaluation of Calibration Equations by Using Regression Analysis: An Example of Chemical Analysis. Sensors (Basel). 2022;22(2).
Bhavyasri K, Surekha T, Rambabu D. Bioanalytical Method Development and Validation of Atorvastatin in Human Plasma by Using UV-Visibile Spectrophotometry. Journal of Pharmaceutical Sciences and Research. 2019;11(6):2243-6.
Tan A, Awaiye K, Jose B, Joshi P, Trabelsi F. Comparison of different linear calibration approaches for LC–MS bioanalysis. Journal of Chromatography B. 2012;911:192-202.
Stalikas C, Sakkas V. From a glimpse into the key aspects of calibration and correlation to their practical considerations in chemical analysis. Mikrochim Acta. 2024;191(2):81.
Araujo P. Key aspects of analytical method validation and linearity evaluation. Journal of Chromatography B. 2009;877(23):2224-34.
Chavan S, Desai D. Analytical method validation: A brief review. World Journal of Advanced Research and Reviews. 2022;16:389-402.
Chesher D. Evaluating assay precision. Clin Biochem Rev. 2008;29 Suppl 1(Suppl 1):S23-6.
Soori H. Precision, Validity, and Repeatability of Measurements and Diagnostic Tests. In: Soori H, editor. Errors in Medical Science Investigations. Singapore: Springer Nature Singapore; 2024. p. 73-96.
Pum J. Chapter Six - A practical guide to validation and verification of analytical methods in the clinical laboratory. In: Makowski GS, editor. Advances in Clinical Chemistry. 90: Elsevier; 2019. p. 215-81.
Zhou W, Li Z, Bai L, Fu X, Qu B, Miao M. Basics of Measurement and Test Precision and the Effect of Measurement Methods on Measurement Precision. In: Zhou W, Li Z, Bai L, Fu X, Qu B, Miao M, editors. The Border Effect in High-Precision Measurement. Singapore: Springer Nature Singapore; 2023. p. 19-89.
Alhazmi HA, Alnami AM, Arishi MAA, Alameer RK, Al Bratty M, Rehman ZU, et al. A Fast and Validated Reversed-Phase HPLC Method for Simultaneous Determination of Simvastatin, Atorvastatin, Telmisartan and Irbesartan in Bulk Drugs and Tablet Formulations. Sci Pharm. 2017;86(1).
Momenbeitollahi N, Cloet T, Li H. Pushing the detection limits: strategies towards highly sensitive optical-based protein detection. Anal Bioanal Chem. 2021;413(24):5995-6011.
Epshtein N. VALIDATION OF ANALYTICAL PROCEDURES: GRAPHIC AND CALCULATED CRITERIA FOR ASSESSMENT OF METHODS LINEARITY IN PRACTICE. 2019;8:122-30.
Gustavo González A, Ángeles Herrador M. A practical guide to analytical method validation, including measurement uncertainty and accuracy profiles. TrAC Trends in Analytical Chemistry. 2007;26(3):227-38.
Abdel GMT, El-Masry MI. Verification of quantitative analytical methods in medical laboratories. J Med Biochem. 2021;40(3):225-36.
Vander Heyden Y, Nijhuis A, Smeyers-Verbeke J, Vandeginste BGM, Massart DL. Guidance for robustness/ruggedness tests in method validation. Journal of Pharmaceutical and Biomedical Analysis. 2001;24(5):723-53.
Bhavna, Ojha A, Bhargava S. Chapter 3 - International Council for Harmonisation (ICH) guidelines. In: Ali J, Baboota S, editors. Regulatory Affairs in the Pharmaceutical Industry: Academic Press; 2022. p. 47-74.
Kadian N, Raju KSR, Rashid M, Malik MY, Taneja I, Wahajuddin M. Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry. Journal of Pharmaceutical and Biomedical Analysis. 2016;126:83-97.
Bode G. Regulatory Guidance: ICH, EMA, FDA. In: Hock FJ, Gralinski MR, editors. Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Cham: Springer International Publishing; 2019. p. 1-54.
Crevar-Sakač M, Vujić Z, Brborić J, Kuntić V, Uskoković-Marković S. An improved HPLC method with the aid of a chemometric protocol: simultaneous determination of atorvastatin and its metabolites in plasma. Molecules. 2013;18(3):2469-82.
Abhinandana P. A review of various analytical methods on Atrovastatin. 2013.
Badyal P, Sharma C, Kaur N, Shankar R, Pandey A, Rawal R. Analytical Techniques in Simultaneous Estimation: An Overview. Austin Journal of Analytical and Pharmaceutical Chemistry. 2015;2:1037.
Jia J, Zhu F, Ma X, Cao ZW, Li YX, Chen YZ. Mechanisms of drug combinations: interaction and network perspectives. Nature Reviews Drug Discovery. 2009;8(2):111-28.
Parmar A, Sharma S. Derivative UV-vis absorption spectra as an invigorated spectrophotometric method for spectral resolution and quantitative analysis: Theoretical aspects and analytical applications: A review. TrAC Trends in Analytical Chemistry. 2016;77:44-53.
Bosch Ojeda C, Sanchez Rojas F. Recent applications in derivative ultraviolet/visible absorption spectrophotometry: 2009–2011: A review. Microchemical Journal. 2013;106:1-16.
Ortiz Ortega E, Hosseinian H, Rosales López MJ, Rodríguez Vera A, Hosseini S. Characterization Techniques for Chemical and Structural Analyses. In: Ortiz Ortega E, Hosseinian H, Aguilar Meza IB, Rosales López MJ, Rodríguez Vera A, Hosseini S, editors. Material Characterization Techniques and Applications. Singapore: Springer Singapore; 2022. p. 93-152.
Persson B-A, Vessman J. The use of selectivity in analytical chemistry – some considerations. TrAC Trends in Analytical Chemistry. 2001;20(10):526-32.
Saiyed N, Nathani C, Patel S, Saduwala Z, Ugle V, Shah C, et al. SOLUBILITY ENHANCEMENT OF ATORVASTATIN BY DIFFERENT SOLUBILITY ENHANCEMENT TECHNIQUES -A COMPARISION STUDY. 2023;14:39-54.
Shamsuddin, Fazil M, Ansari SH, Ali J. Atorvastatin solid dispersion for bioavailability enhancement. J Adv Pharm Technol Res. 2016;7(1):22-6.
Shaker MA, Elbadawy HM, Shaker MA. Improved solubility, dissolution, and oral bioavailability for atorvastatin-Pluronic® solid dispersions. Int J Pharm. 2020;574:118891.
Rudrapal M, Kothawade AP, Ezzat SM, Egbuna C. Chapter 1 - Bioanalysis: methods, techniques, and applications. In: Egbuna C, Patrick-Iwuanyanwu KC, Shah MA, Ifemeje JC, Rasul A, editors. Analytical Techniques in Biosciences: Academic Press; 2022. p. 1-24.
Badawy MEI, El-Nouby MAM, Kimani PK, Lim LW, Rabea EI. A review of the modern principles and applications of solid-phase extraction techniques in chromatographic analysis. Anal Sci. 2022;38(12):1457-87.
Hewavitharana AK, Abu Kassim NS, Shaw PN. Standard addition with internal standardisation as an alternative to using stable isotope labelled internal standards to correct for matrix effects-Comparison and validation using liquid chromatography-tandem mass spectrometric assay of vitamin D. J Chromatogr A. 2018;1553:101-7.
Cheng WL, Markus C, Lim CY, Tan RZ, Sethi SK, Loh TP. Calibration Practices in Clinical Mass Spectrometry: Review and Recommendations. Ann Lab Med. 2023;43(1):5-18.
Ríos-Reina R, Azcarate SM. How Chemometrics Revives the UV-Vis Spectroscopy Applications as an Analytical Sensor for Spectralprint (Nontargeted) Analysis. Chemosensors. 2023;11(1):8.
Antony A, Mitra J. Refractive index-assisted UV/Vis spectrophotometry to overcome spectral interference by impurities. Analytica Chimica Acta. 2021;1149:238186.
Redasani V, Patel P, Marathe D, Chaudhari S, Shirkhedkar A, Surana S. A review on derivative uv-spectrophotometry analysis of drugs in pharmaceutical formulations and biological samples review. Journal of the Chilean Chemical Society. 2018;63:4126-34.
Sowjanya G, S G, Almas S. DERIVATIVE UV SPECTROSCOPIC APPROACHES IN MULTICOMPONENT ANALYSIS–A REVIEW. International Journal of Pharmacy and Pharmaceutical Sciences. 2018:1-11.
Tarapoulouzi M, Mironescu M, Drouza C, Mironescu ID, Agriopoulou S. Insight into the Recent Application of Chemometrics in Quality Analysis and Characterization of Bee Honey during Processing and Storage. Foods. 2023;12(3):473.
Mukherjee P, Chakraborty D, Chakraborty P, Shrestha B, Bhuyan N. DIFFERENT ULTRAVIOLET SPECTROSCOPIC METHODS: A RETROSPECTIVE STUDY ON ITS APPLICATION FROM THE VIEWPOINT OF ANALYTICAL CHEMISTRY. Asian Journal of Pharmaceutical and Clinical Research. 2021:1-11.
Gupta RS, Tiwari A, Patel SK, Karthikeyan C, Gupta DK, Soni P, et al. Development and validation of a UV spectrophotometric method for simultaneous estimation of teneligliptin hydrobromide hydrate and pioglitazone hydrochloride in pharmaceutical dosage form. Future Journal of Pharmaceutical Sciences. 2024;10(1):172.
Vyas AJ, Desai DU, Patel A, Patel A, Shah S, Sheth D. A Brief Review on Dual Wavelength Spectrophotometry: The Simultaneous Estimation Method and its Application. Asian Journal of Pharmaceutical Analysis. 2024;14(3):166-74.
Nurani L, Ariani C, Irnawati I, Putri A, Windarsih A, Guntarti A, et al. Chemometrics-Assisted UV-Vis Spectrophotometry for Quality Control of Pharmaceuticals: A Review. Indonesian Journal of Chemistry. 2023;23:542.
Bajaj S, Singla D, Sakhuja N. Stability Testing of Pharmaceutical Products. Journal of Applied Pharmaceutical Science. 2012;2:129-38.
Tembhare E, Gupta K, Umekar M. An Approach to Drug Stability Studies and Shelf-life Determination. Archives of Current Research International. 2019:1-20.
Singh S, Mishra A, Verma A, Ghosh AK, Mishra AK. A simple Ultraviolet spectrophotometric method for the determination of etoricoxib in dosage formulations. J Adv Pharm Technol Res. 2012;3(4):237-40.
Manideep G, Shane J, Pai K, Krishna M. Development and Validation of A UV Spectroscopic Method to Estimate Etoricoxib in Bulk and Tablet Formulation. Research Journal of Pharmacy and Technology. 2018;11:758.
Kondawar M, D B, Maniyar M, hirve r. Spectrophotometric method for Simultaneous estimation of Atorvastatin Calcium & Fenofibrate in tablet Dosage Form. International Journal of Drug Development & Research. 2013;5:1-5.
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