Development and validation of RPLC method for the simultaneous analysis of ACE inhibitors in tablet formulations

Year 2022, Volume: 4 Issue: 2, 103 - 110, 29.12.2022

Erdem Kuzucanlı , Ebru Çubuk Demiralay , Yaşar Doğan Daldal , Zehra Üstün , İlkay Konçe , Abbase Güleren Alsancak

https://doi.org/10.51435/turkjac.1176649

Cited By: 3

Abstract

Hypertension is a disease that can progress for many years without symptoms or complications. This disease can cause death and permanent damage to vital organs such as the kidney, heart, and brain. However, when hypertension is treated effectively, these risk factors may decrease significantly. Although many antihypertensive drugs are used in the treatment of hypertension, ACE inhibitors are a new class among these drugs, and their separation and quantitative determinations are important for the success of preclinical, biopharmaceutical, and clinical studies. For this reason, in this study, the simultaneous determination of cilazapril, benazepril, and quinapril from ACE inhibitors, the validation of the developed method, and the quantitative determination of commercial drug dosage forms are aimed. To obtain the optimum liquid chromatographic separation condition, a systematic approach based on the relationship between mobile phase pH and retention time was used. The mobile phase organic modified concentration and column temperature parameters, which are known to affect the retention times of the compounds, were kept constant. When deciding on these parameters, few experiments were carried out.

Keywords

Hypertension, ACE inhibitors, RPLC, method optimization, pKa

Supporting Institution

Süleyman Demirel University Scientific Research Projects Coordination

Project Number

4578-YL2-16

Thanks

Many thanks to Suleyman Demirel University for supporting to our study.

References

• I. Maraj, J. N. Makaryus, A.Ashkar, S.I. McFarlane, A.N. Makaryus, Hypertension management in the high cardiovascular risk population, International Journal of Hypertension, 2013, 2013, 1-7.
• N.J. Brown, D.E. Vaughan, Angiotensin-converting enzyme inhibitors, Circulation, 97, 1998, 1411-1420.
• L. Brunton, B. Chabner, B. Knollman, Goodman and Gilman’s The Pharmacological Basis of Therapeutics (9. edition), 1996, New York, McGraw-Hill.
• R. Kumar, R. Sharma, K. Bairwa, R. Kumar Roy, A. Kumar, A. Baruwa, Modern development in ACE inhibitors, Der Pharmacia Lettre, 2(3), 2010, 388-419.
• B.G. Katzung, Basic & Clinical Pharmacology (12. edition), 2011, San Francisco, The McGraw-Hill Companies.
• S.D. Firke, K.R. Bhoi, K.R. Patil, S.D. Jayswal, A.R. Tekade, S.S. Chalikwar, A State-Of-The-Art Review on Applications of Different Analytical Techniques for Some ACE Inhibitors, Analytical Chemistry Letters, 10(1), 2020, 60-79.
• Y. Kazakevich, Y. Lobrutto, HPLC for Pharmaceutical Scientists (1. edition), 2007, Canada, Wiley-Interscience.
• V.R. Meyer, Practical High-Performance Liquid Chromatography (16. edition), 2010, United Kingdom, John Wiley and Sons, Ltd.
• Y.D. Daldal, E.Ç. Demiralay, S.A. Ozkan, Effect of organic solvent composition on dissociation constants of some reversible acetylcholinesterase inhibitors, Journal of the Brazilian Chemical Society, 27(3), 2016, 493-499.
• Y.D. Daldal, E.Ç. Demiralay, Chromatographic and UV–visible spectrophotometric pKa determination of some purine antimetabolites, Journal of Molecular Liquids, 317, 2020, 1-8.
• ICH, Validation of Analytical Procedures: Text and Methodology Q2 (R1) Harmonized Tripartite Guideline 2005.
• E.C. Demiralay, D. Koc, Y.D. Daldal, C. Cakır, Determination of Chromatographic and Spectrophotometric Dissociation Constants of Some Beta Lactam Antibiotics, Journal of Pharmaceutical and Biomedical Analysis, 71, 2012, 139– 143.
• E.Ç. Demiralay, Z. Üstün, Y.D. Daldal, Estimation of Thermodynamic Acidity Constants of Some Penicillinase-Resistant Penicillins, Journal of Pharmaceutical and Biomedical Analysis, 91, 2014, 7– 11.
• E.Ç. Demiralay, An Experimental Design Approach to Optimization of the Liquid Chromatographic Separation Conditions for the Determination of Metformin and Glibenclamide in Pharmaceutical Formulation, Acta Chimica Slovenica, 59(2), 2012, 307-314.
• T. Lundsted, E. Seifert, L. Abramo, B. Thelin, A. Nyström, J. Pettersen, R. Bergamn, Experimental Design and Optimization, Chemometrics and Intelligent Laboratory Systems, 42, 1998, 3-40.
• S. Bolton, C. Bon, Pharmaceutical Statistics Practical and Clinical Application (4. edition), 2004, Boca Raton, CRC Press.
• D. Bonazzi, R. Gotti, V. Andrisano, V. Cavrini, Analysis of ACE Inhibitors in Pharmaceutical Dosage Forms by Derivative UV Spectroscopy and Liquid Chromatography (HPLC), Journal of Pharmaceutical and Biomedical Analysis, 16(3), 1997, 431-438.
• A. Gumieniczek, H. Hopkala, High-performance Liquid Chromatographic Assay of Quinapril in Tablets, Pharmaceutica Acta Helvetiae, 73(4), 1998, 183-185.
• J.A. Prieto, R.M. Jiménez, R.M. Alonso, Quantitative Determination Of The Angiotensin-Converting Enzyme Inhibitor Cilazapril And Its Active Metabolite Cilazaprilat In Pharmaceuticals And Urine By High-Performance Liquid Chromatography With Amperometric Detection, Journal of Chromatography B: Biomedical Sciences and Applications, 714(2), 1998, 285-292.
• L. Manna, L. Valvo, S. Alimonti, A Liquid Chromatographic Lon-Pairing Method For Simultaneous Determination Of Benazepril Hydrochloride, Fosinopril Sodium, Ramipril And Hydrochlorothiazide In Pharmaceutical Formulations. Chromatographia, 53(1), 2001, 271-275.
• F. Elsebaei, Y. Zhu, Fast Gradient High Performance Liquid Chromatography Method With Uv Detection For Simultaneous Determination Of Seven Angiotensin Converting Enzyme Inhibitors Together With Hydrochlorothiazide In Pharmaceutical Dosage Forms And Spiked Human Plasma And Urine. Talanta, 85(1), 2011, 123-129.
• S. Kiran, T.Y. Pasha, M. Asif, M. Kamal, T. Jawaid, M.A Alossaimi, B. Ramesh, M. Majumder, Development And Validation Of A Reverse Phase-High Performance Liquid Chromatography Method For The Assay Of Benazepril Hydrochloride Using A Quality-By-Design Approach, Latin American Journal of Pharmacy, 41(5), 2022, 931-943.
• B. Otašević, J. Šljivić, A. Protić, N. Maljurić, A. Malenović, M. Zečević, Comparison of AQbD and Grid Point Search Methodology In The Development Of Micellar HPLC Method For The Analysis Of Cilazapril And Hydrochlorothiazide Dosage Form Stability, Microchemical Journal, 145, 2019, 655-663.
• S.M. Auwal, M. Zarei, C.P. Tan, M. Basri, N. Saari, Enhanced Physicochemical Stability And Efficacy Of Angiotensin I-Converting Enzyme (ACE) - Inhibitory Biopeptides By Chitosan Nanoparticles Optimized Using Box- Behnken Design, Scientific Reports, 8, 2018, 1-11.
• D.T. Manallack. The pKa Distribution of Drugs: Application to Drug, Perspect Medicin Chem., 1, 2007, 25–38.
• M. Remko, Acidity, Lipophilicity, Solubility, Absorption, and Polar Surface Area of Some ACE Inhibitors. Chem. Zvesti CHEM PAP, 61(2), 2007, 133-141.
• Y.D. Daldal, E.Ç. Demiralay, Development of Liquid Chromatographic And UV-Visible Spectrophotometric Methods For Determination Of pKa Values Of Folic Acid Antimetabolites, Journal of Pharmaceutical and Biomedical Analysis, 212, 2022,1-8.
• A. Vonaparti, M. Kazanis, I. Panderi, Development and Validation of a Liquid Chromatographic/Electrospray Ionization Mass Spectrometric Method For The Determination Of Benazepril, Benazeprilat And Hydrochlorothiazide In Human Plasma, Journal of Mass Spectrometry, 41, 2006, 593–605.
• S.K. Paszun, B, Stanisz, W. Pawlowski, Rapid And Simple Stability Indicating HPLC Method For The Determination Of Cilazapril In Pure Substance And Pharmaceutical Formulation In Comparison With Classic And Derivative Spectrophotometric Methods, Acta Poloniae Pharmaceutica, 69(2), 2012, 193-201.
• M.E. Swartz, I.S. Krull, Handbook of Analytical Validation (1. edition), 2012, Boca Raton, CRC Press.