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Shulyak N, Piponski M, Kovalenko S, et al. Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs. J Sep Sci. 2021;44(15):2908-2916doi: 10.1002/jssc.202100168.
Shulyak, N., Piponski, M., Kovalenko, S., Stoimenova, T. B., Drapak, I., Piponska, M., Rezk, M. R., Abbeyquaye, A. D., Oleshchuk, O., & Logoyda, L. (2021). Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs. Journal of separation science, 44(15), 2908-2916. https://doi.org/10.1002/jssc.202100168
Shulyak, Nataliia, et al. "Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs." Journal of separation science vol. 44,15 (2021): 2908-2916. doi: https://doi.org/10.1002/jssc.202100168
Shulyak N, Piponski M, Kovalenko S, Stoimenova TB, Drapak I, Piponska M, Rezk MR, Abbeyquaye AD, Oleshchuk O, Logoyda L. Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs. J Sep Sci. 2021 Aug;44(15):2908-2916. doi: 10.1002/jssc.202100168. Epub 2021 Jun 17. PMID: 34047016.
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J Sep Sci. 2021 Aug;44(15):2908-2916. doi: 10.1002/jssc.202100168. Epub 2021 Jun 17.

Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs.

Journal of separation science

Nataliia Shulyak, Marjan Piponski, Sergiy Kovalenko, Tanja Bakovska Stoimenova, Iryna Drapak, Magdalena Piponska, Mamdouh R Rezk, Annie Donkor Abbeyquaye, Oleksandra Oleshchuk, Liliya Logoyda

Affiliations

  1. Department of Pharmaceutical Chemistry, Ivan Horbachevsky Ternopil National Medical University, Ternopil, Ukraine.
  2. Municipal Institution of Higher Education Volyn Medical Institute of the Volyn Oblast Council, Lutsk, Ukraine.
  3. Replek Farm Limited, Skopje, North Macedonia.
  4. Department of Organic and Bioorganic Chemistry, Zaporizhzhia State Medical University, Zaporizhzhia, Ukraine.
  5. Department of General, Bioinorganic, Physical, and Colloidal Chemistry, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.
  6. Institute for Clinical Biochemistry, University Clinical Center Mother Theresa, Skopje, North Macedonia.
  7. Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
  8. Department of Pharmacology and Clinical Pharmacology, Ivan Horbachevsky Ternopil National Medical University, Ternopil, Ukraine.

PMID: 34047016 DOI: 10.1002/jssc.202100168

Abstract

Simultaneous determination of drugs with different physicochemical properties necessitates thorough research and careful selection of high-performance liquid chromatography conditions. In the present study, various concepts of high-performance liquid chromatography method development for this aim have been discussed. Moreover, the work was motivated by the advantages of utilizing different chaotropic anions as a new promising approach to overcome the limitations of ion-pairing agents commonly used for this purpose. Based on log P values, atorvastatin (log P = 6.36) and lisinopril (log P = -1.22) were chosen as representative examples for lipophilic and hydrophilic drugs, respectively. Several simple, economic, fast, and reliable high-performance liquid chromatography methods were developed for their simultaneous analysis and are presented in a comparative manner, highlighting their advantages and limitations. Peak elution profile showed satisfying retentions and resolution about 3. Photo-diode array calculations were exploited for identifying the molecules by their ultra-violet spectra and peak purity, calculated and presented as rectangular-shaped ratio grams. The linearity check showed excellent results and satisfactory system suitability parameters of both peaks. This confirms the investigation results and conclusions for the influence of the chaotropic salts on N-containing molecules, by increasing their retentivities, and improving peak shapes, even on different quality columns without end-capping and base-deactivating of separation matrixes.

© 2021 Wiley-VCH GmbH.

Keywords: atorvastatin; chaotropic anions; dosage form; liquid chromatography; lisinopril

References

  1. Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischemic heart disease, and stroke: Systematic review and meta-analysis. Br Med J. 2003;326:1423. - PubMed
  2. Tamargo J, Caballero R, Gomez R, Nunez L, Vaquero M, Delpon E. Lipid-lowering therapy with statins, a new approach to antiarrhythmic therapy. Pharmacol Ther. 2007;114:107-26. - PubMed
  3. Zhang L, Zhang S, Jiang H, Sun A, Zou Y, Ge J. Effects of statin treatment on cardiac function in patients with chronic heart failure: a meta-analysis of randomized controlled trials. Clin Cardiol. 2011;34:117-23. - PubMed
  4. Athyros VG, Mikhailidis DP, Papageorgiou AA, Bouloukos VI, Pehlivanidis AN, Symeonidis AN, Elisaf M. Effect of statins and ACE inhibitors alone and in combination on clinical outcome in patients with coronary heart disease. J Hum Hypertens. 2004;18:781-8. - PubMed
  5. Chaudhari GB, Patel MN, Shah BP. Stability indicating RP-HPLC method for simultaneous determination of atorvastatin and amlodipine from their combination drug products. Chem Pharm Bull. 2007;55:241-6. - PubMed
  6. Hafez HM, Elshanawany AA, Abdelaziz LM, Mohram MS. Development of a stability-indicating HPLC method for simultaneous determination of amlodipine besylate and atorvastatin calcium in tablets. Austin J Anal Pharm Chem. 2014;1:1-11. - PubMed
  7. Shah AD, Bhatt KK, Mehta SR, Shankar BM, Baldania LS. RP-HPLC method for the determination of atorvastatin calcium and nicotinic acid in combined tablet dosage form. Indian J Pharm Sci. 2007;69:700-3. - PubMed
  8. Patole MS, Potale VL, Khodke SA, Damle CM. A validated HPLC method for analysis of atorvastatin calcium, ramipril and aspirin as the bulk drug and in combined capsule dosage form. Int J Pharm Sci Rev. 2010;4:40-5. - PubMed
  9. Londhe VS, Deshmukh SR, Mulgund VS, Jain SK. Development and validation of a reversed-phase HPLC method for simultaneous determination of aspirin, atorvastatin calcium and clopidogrel bisulphate in capsules. Indian J Pharm Sci. 2011;73:23-9. - PubMed
  10. Kumar PSN, Gowda BDG, Deepu VC, Mantelingu K, Rangappa KS. Simultaneous estimation of statins like pravastatin, atorvastatin and simvastatin in bulk and in pharmaceutical dosage by means of high-performance liquid chromatography. J Chem Pharm Res. 2013;5:359-64. - PubMed
  11. Sathiyasundar R, Valliappan K. An improved RP-HPLC method for the simultaneous estimation of aspirin, atorvastatin and clopidogrel in pharmaceutical formulation using experimental design methodology. Int J Pharm Pharm. 2014;6:279-83. - PubMed
  12. Lakshmi RV, Sreedevi B. Simultaneous estimation of atorvastatin and olmesartan in bulk and pharmaceutical formulations by RP-HPLC method. Int J Innov Techn Res. 2014;2:1559-63. - PubMed
  13. Gurram CS. RP-HPLC method development and validation for the simultaneous estimation of atorvastatin, fenofibrate and ezetimibe in a pharmaceutical dosage form. Biochem Anal Biochem. 2015;4:1-4. - PubMed
  14. Ertürk S, Aktas SE, Ersoy L, Ficiciȯǧlu S. An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets. J Pharm Biomed Anal. 2003;33:1017-23. - PubMed
  15. Stanisz B, Kania L. Validation of HPLC method for determination of atorvastatin in tablets and for monitoring stability in solid phase. Acta Pol Pharm. 2006;63:471-6. - PubMed
  16. Zaheer Z, Farooqui M, Mangle AA, Nikalje GPO. Stability-indicating high performance liquid chromatographic determination of atorvastatin calcium in pharmaceutical dosage form. Afr J Pharm Pharmacol. 2008;2:204-10. - PubMed
  17. Petkovska R, Cornett C, Dimitrovska A. Development and validation of rapid resolution RP-HPLC method for simultaneous determination of atorvastatin and related compounds by use of chemometrics. Anal Lett. 2008;41:992-1009. - PubMed
  18. Kumar KK, Rao KC, Lakshmi VM, Mukkanti K. A validated stability indicating RP-HPLC method for atorvastatin calcium. Am J Anal Chem. 2012;3:392-9. - PubMed
  19. Vakkum P, Babu MJ, Muralikrishna R. Stress degradation behavior of atorvastatin calcium and development of a suitable stability-indicating LC method for the determination of atorvastatin, its related impurities and its degradation products. Sci Pharm. 2013;81:93-114. - PubMed
  20. Piponski M, Bakovska Stoimenova T, Piponska M, Trendovska Serafimovska G. Concepts in development of fast, simple, stability indicating HPLC method for analysis of atorvastatin related compounds in tablets. J Anal Pharm Res. 2018;7:450-7. - PubMed
  21. Chauhan V, Prajapati ST, Patel CN. A validated RP-HPLC method for simultaneous estimation of amlodipine and lisinopril in pharmaceutical dosage form. Int J Pharm Sci Res. 2011;2:1712-5. - PubMed
  22. Naveed S, Sultana N, Arayne MS. Simultaneous determination of lisinopril and H2 antagonists in API, formulations and human serum by using two different HPLC systems. Med Chem Res. 2012;21:4037-42. - PubMed
  23. Arayne MS, Sultana N, Zuberi MH, Siddiqui FA, Haroon U. Simultaneous determination of metformin, captopril, lisinopril, and enalapril by RP-HPLC: Its applications in dosage formulations and in human serum. Med Chem Res. 2013;22:5717-22. - PubMed
  24. Andreas T, Bairachtari K, Georgarakis M. Development of a liquid chromatography-mass spectrometry method for monitoring the angiotensin converting enzyme inhibitor lisinopril in serum. J Chromatogr B. 2003;783:425-32. - PubMed
  25. Sun C, Zhu P, Hu N, Wang D, Pan Y. Differentiation of lisinopril and its RSS diastereomer by liquid chromatography combined with collision-induced dissociation mass spectrometry. J Mass Spectrom. 2010;45:89-96. - PubMed
  26. Sultana N, Arayne MS, Siddiqui R, Naveed S. RP-HPLC method for the simultaneous determination of lisinopril and NSAIDs in API, pharmaceutical formulations and human serum. Am J Analyt Chem. 2012;3:147-52. - PubMed
  27. Sultana N, Arayne MS, Naveed S. Validated method for the simultaneous determination of lisinopril, pravastatin, atorvastatin and rosuvastatin in API, formulations and human serum by RP-HPLC. Chin J Chem. 2011;29:1216-20. - PubMed
  28. Alzoman NZ, Alshehri MM, Sultan MA, Maher HM, Olah IV, Darwish IA. Micellar electrokinetic capillary chromatographic determination of a polypill combination containing, lisinopril, hydrochlorothiazide, aspirin, and atorvastatin. Anal Methods. 2013;5, 1238-44. - PubMed
  29. Moffat AC, Osselton MD, Widdop B, Watts J. Clarke's analysis of drugs and poisons. 4th ed. London: Pharmaceutical Press; 2011. - PubMed
  30. Kazakevic Y, Lobruto R. HPLC for practicing scientist. Hoboken, NJ: John Wiley & Sons; 2007. - PubMed
  31. Piponski M, Peleshok K, Logoyda L, Kravchuk L, Piatnochka V, Zakharchuk U. Efficient validated HPLC/UV method for determination of valsartan and atenolol in dosage form and in vitro dissolution studies. Biointerface Res Appl Chem. 2020;10:6669-75. - PubMed
  32. Peleshok K, Piponski M, Kovalenko S, Ahmed H, Abdel-Megied A, Ezike OF, Logoyda L. New liquid chromatography assays for simultaneous quantification of antihypertensives atenolol and valsartan in their dosage forms. J Sep Sci. 2020;44:565-75. - PubMed
  33. Piponski M, Stoimenova BT, Serafimovska TG, Stefova M. Development and validation of fast, simple, cost-effective and robust RP-HPLC method for simultaneous determination of lisinopril and amlodipine in tablets. Anal Chem Lett. 2019;9:385-402. - PubMed
  34. Kazakevich YV, LoBrutto R, Vivilecchia R. Reversed-phase high-performance liquid chromatography behavior of chaotropic counteranions. J Chromatogr A. 2005;1064:9-18. - PubMed
  35. Flieger J. The effect of chaotropic mobile phase additives on the separation of selected alkaloids in reversed-phase high-performance liquid chromatography. J Chromatogr A. 2006;1113:37-44. - PubMed
  36. International conference on harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use. Validation of analytical procedures: Text and methodology Q2(R1). Geneva, Switzerland; 2005. - PubMed

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