Electrochemical behavior and differential pulse voltammetric determination of budesonide in suspension ampoules

Yıl 2023, Cilt: 53 Sayı: 2, 150 - 158, 30.08.2023

Orkhan Yolchuyev , Zeynep Aydoğmuş

https://doi.org/10.26650/IstanbulJPharm.2023.1093821

Öz

Background and Aims: Budesonide (BUD) is a broad-spectrum anti-inflammatory and anti-allergic glucocorticosteroid agent. It is used in the treatment of chronic obstructive pulmonary disease (COPD), Crohn's disease, and ulcerative colitis. The aim of the study was to investigate the electrochemical properties of BUD for the first time and to develop a sensitive, easy, and selective new differential pulse voltammetry (DPV) method for its determination in drug formulation.
Methods: The electrochemical behavior of BUD was investigated using cyclic voltammetry (CV) and differential pulse voltammetry (DPV) with a carbon paste electrode (CPE) in various electrolyte and buffer solutions with pH ranging from 2 to 9. An irreversible, well-defined reduction current peak of about -859 mV was obtained. A DPV method was developed and validated for the determination of BUD in suspension ampoules using a CPE electrode in a 0.1 M HCl electrolyte solution containing 13% KCl and 8% methanol.
Results: The cathodic peak was found to be adsorption-controlled. The calibration curve was linear between 1.65- 35.35 µg/ml. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 0.52 µg/mL and 1.57 µg/mL, respectively. The developed method offered an effective capability for the determination of BUD in suspension ampoules, with a recovery rate of 98.47%.
Conclusion: The DPV method developed in this study could be used for routine quantitative analysis of BUD in pharmaceutical preparations due to its fast, accurate, inexpensive, and environmentally friendly nature.

Anahtar Kelimeler

Budesonide, determination, pharmaceutical preparation, validation, voltammetry

Proje Numarası

TYL-2020-35210.

Kaynakça

• Ahmed, S., & Atia, N. N. (2019). Controlled microwave derivatiza-tion reaction for reproducible trace analysis of budesonide in hu-man plasma. Analytica Chimica Acta, 1048, 132-142. https://doi. org/10.1016/j.aca.2018.09.059 google scholar
• Alimohammadi, S., Kiani, M. A., Imani, M., Rafii-Tabar, H., & Sasan-pour, P. (2019). Electrochemical determination of dexamethasone by graphene modified electrode: experimental and theoretical in- vestigations. Scientific Reports, 9(1), 1-10. https://doi.org/10.1038/ s41598-019-47420-0 google scholar
• Aydoğmuş, Z., Aslan, S. S., Yildiz, G., & Senocak, A. (2020). Dif-ferential Pulse Voltammetric Determination of Anticancer Drug Regorafenib at a Carbon Paste Electrode: Electrochemical Study and Density Functional Theory Computations. Journal of Analytical Chemistry, 75(5), 691-700. https://doi.org/10.1134/ S1061934820050032 google scholar
• Bharti, P., Sachan, N., Chandra, P., & Shantakumar, S. M. (2011). De-velopment and validation of selective UV spectrophotometric analytical method for budesonide pure sample. Journal of Ap-plied Pharmaceutical Science, (01 (07)), 158-161. https://japson-line.com/admin/php/uploads/195_pdf.pdf google scholar
• Bond, A.M. (1980). Modern polarographic methods in analytical chemistry (c. 4) (pp 185-252): CRC Press. NewYork, USA. https:// doi.org/10.1201/9781003065036 google scholar
• Gazzotti, T., Barbarossa, A., Zironi, E., Roncada, P., Pietra, M., & Pa-gliuca, G. (2016). An LC-MS/MS method for the determination of budesonide and 16a-hydroxyprednisolone in dog plasma. Meth-odsX, 3, 139-143. https://doi.org/10.1016/j.mex.2016.02.004 google scholar
• Ghoneim, E. M., El-Attar, M. A., & Ghoneim, M. M. (2009). Adsorptive cathodic stripping voltammetric determination of dexamethasone in formulations and biological fluids. Journal of AOAC Internation-al, 92(2), 597-603. https://doi.org/10.1093/jaoac/92.2.597 google scholar
• Goyal, R. N., Chatterjee, S., & Rana, A. R. S. (2010). Effect of cetyltri-methyl ammonium bromide on electrochemical determination of dexamethasone. Electroanalysis, 22(20), 2330-2338. https://doi. org/10.1002/elan.201000227 google scholar
• Goyal, R. N., Gupta, V. K., & Chatterjee, S. (2009). A sensitive voltam-metric sensor for determination of synthetic corticosteroid triam-cinolone, abused for doping. Biosensors and Bioelectronics, 24(12), 3562-3568. https://doi.org/10.1016/j.bios.2009.05.016 google scholar
• ICH Harmonised Tripartite Guideline, (2005). Validation of analyti-cal procedures: text and methodology. Q2 (R1), 1(20), 05, Somatek Inc.: San Diego CA, USA. google scholar
• Guidelli, R., Compton, R. G., Feliu, J. M., Gileadi, E., Lipkowski, J., Schmickler, W., & Trasatti, S. (2014). Defining the transfer coef-ficient in electrochemistry: An assessment (IUPAC Technical Report). Pure and Applied Chemistry, 86(2), 245-258. https://doi. org/10.1515/pac-2014-5026 google scholar
• Gupta, M., & Bhargava, H. N. (2006). Development and valida-tion of a high-performance liquid chromatographic method for the analysis of budesonide. Journal of Pharmaceutical and Biomedical Analysis, 40(2), 423-428. https://doi.org/10.1016/j. jpba.2005.06.038 google scholar
• Hammam, E. (2007). Determination of triamcinolone acetonide in pharmaceutical formulation and human serum by adsorp-tive cathodic stripping voltammetry. Chemia Analityczna, 52(1), 43-53. http://beta.chem.uw.edu.pl/chemanal/PDFs/2007/CHAN-2007V52P00043.pdf google scholar
• Hofer, K. N. (2003). Oral budesonide in the management of Crohn’s disease. Annals of Pharmacotherapy, 37(10), 1457-1464. https://doi.org/10.1345/aph.1d059. google scholar
• Hou, S., Hindle, M., & Byron, P. R. (2001). A stability-indicating HPLC assay method for budesonide. Journal of Pharmaceutical and Bio-medical Analysis, 24(3) 371-380. https://doi.org/10.1016/s0731-7085(00)00424-6 google scholar
• Hryniewicka, M., Starczewska, B., Gotşbiewska, A. (2019). Determi-nation of budesonide and sulfasalazine in water and wastewater samples using DLLME-SFO-HPLC-UV method. Water, 11(8), 1581. https://doi.org/10.3390/w11081581 google scholar
• Kolsure, A., Daniel, K., & Bhat, M. (2021). Analytical methods for estimation of Budesonide in bulk and in pharmaceutical dos-age forms: A Review. Research Journal of Pharmacy and Tech-nology, 14(5), 2873-2877. http://dx.doi.org/10.52711/0974-360X.2021.00505 google scholar
• Krzek, J., Czekaj, J. S., Rzeszutko, W., & Jonczyk, A. (2004). Direct separation, identification and quantification of epimers 22R and 22S of budesonide by capillary gas chromatography on a short analytical column with Rtx®-5 stationary phase. Journal of Chromatography B, 803(2), 191-200. https://doi.org/10.1016/j. jchromb.2003.12.038 google scholar
• Laviron, E. (1979). The general expression of the linear potential sweep voltammogram in the case of diffusionless electrochemi-cal systems. Journal of Electroanalytical Chemistry and Interfacial Electrochemistry, 101(1), 19-28. https://doi.org/10.1016/S0022-0728(79)80075-3 google scholar
• Matabosch, X., Pozo, O. J., Perez-Mana, C., Farre, M., Marcos, J., Segura, J., & Ventura, R. (2012). Identification of budesonide me-tabolites in human urine after oral administration. Analytical and Bioanalytical Chemistry, 404(2), 325-340. https://doi.org/10.1007/ s00216-012-6037-0 google scholar
• Peng, M., Song, D., Ling, X., Jiang, W., Zhang, Y., Yang, Y., Le, J. (2022). Using thermal forced degradation approach for impurity profiling of budesonide solution-formulated metered dose inha-lation with implementation of LC-QTOFMS and HPLC-UV. Journal of Pharmaceutical and Biomedical Analysis, 208, 114445. https:// doi.org/10.1016/j.jpba.2021.114445 google scholar
• Prasad, A. V. S. S. (2006). Simultaneous spectrophotometric deter-mination of formoterol fumarate and budesonide in their com-bined dosage form. Indian Journal of Chemical Technology 13, 8183. http://nopr.niscpr.res.in/handle/123456789/7001 google scholar
• Rezaei, B., & Mirahmadi-Zare, S. Z. (2011). Nanoscale Manipula-tion of prednisolone as electroactive configuration using mo-lecularly imprinted-multiwalled carbon nanotube paste elec-trode. Electroanalysis, 23(11), 2724-2734. https://doi.org/10.1002/ elan.201100261 google scholar
• Rower, J. E., Anderson, D. J., Sherwin, C. M., Reilly, C. A., Ballard, P. L., McEvoy, C. T., & Wilkins, D. G. (2019). Development and valida-tion of an assay for quantifying budesonide in dried blood spots collected from extremely low gestational age neonates. Journal of Pharmaceutical and Biomedical Analysis, 167, 7-14. https://doi. org/10.1016/j.jpba.2019.01.048 google scholar
• Salem, Y. A., Shaldam, M. A., El-Sherbiny, D. T., El-Wasseef, D. R., & El-Ashry, S. M. (2017). Simultaneous determination of formoterol fumarate and budesonide epimers in metered dose inhaler us-ing ion-pair chromatography. Journal of Chromatographic Sci-ence, 55(10), 1013-1020. https://doi.org/10.1093/chromsci/ bmx067 google scholar
• Sanap, D. D., Sisodia, A. M., Patil, S. H., & Janjale, M. V. (2011). Novel and validated spectrophotometric determination of budesonide from bulk and tablets using mixed hydrotropic solubilization technique. International Journal of Pharmaceutical Sciences and Research, 2(9), 2419-2423. google scholar
• Sartori, E. R., Clausen, D. N., Pires, I. M. R., & Salamanca-Neto, C. A. R. (2017). Sensitive square-wave voltammetric determination of tadalafil (Cialis®) in pharmaceutical samples using a cath-odically pretreated boron-doped diamond electrode. Diamond and Related Materials, 77, 153-158. https://doi.org/10.1016/j.dia-mond.2017.07.001 google scholar
• Scott, K., & Yu, E. H. (Eds.). (2015). Microbial electrochemical and fuel cells: fundamentals and applications. 1st edition. Woodhead Pub-lishing, Cambridge, UK. google scholar
• Speranza, G. (2019). The role of functionalization in the appli-cations of carbon materials: an overview. Journal of Carbon Re-search, 5(4), 84. https://doi.org/10.3390/c5040084 google scholar
• Szefler, S. J. (2001). A review of budesonide inhalation suspen-sion in the treatment of pediatric asthma. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 21(2), 195-206. https://doi.org/10.1592/phco.21.2.195.34115 google scholar
• Szeitz, A., Manji, J., Riggs, K. W., Thamboo, A., & Javer, A. R. (2014). Validated assay for the simultaneous determination of cortisol and budesonide in human plasma using ultra high-performance liquid chromatography-tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis, 90, 198-206. https://doi. org/10.1016/j.jpba.2013.12.006 google scholar
• Varshosaz, J., Emami, J., Tavakoli, N., Minaiyan, M., Rahmani, N., Ahmadi, F., & Dorkoosh, F. (2011). Development and validation of a rapid HPLC method for simultaneous analysis of budesonide and its novel synthesized hemiesters in colon specific formula-tions. Research in Pharmaceutical Sciences, 6(2), 107-116. https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC3249773/pdf/JRPS-6-107.pdf google scholar
• Vedhi, C., Eswar, R., Prabu, H. G., & Manisankar, P. (2008). Deter-mination of triamcinolone acetonide steroid on glassy carbon electrode by stripping voltammetric methods. International Jour-nal of Electrochemical Science, 3, 509-518. https://doi.org/10.1016/ S1452-3981(23)15469-1 google scholar