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Review Articles

A Critical Review of Analytical Methods in Pharmaceutical Matrices for Determination of Corticosteroids

, , & ORCID Icon
Pages 111-124 | Published online: 14 Mar 2019

References

  • Ramamoorthy, S.; Cidlowski, J. A. Corticosteroids: Mechanisms of Action in Health and Disease. Rheum. Dis. Clin. North Am. 2016, 42, 15–31. DOI: 10.1016/j.rdc.2015.08.002.
  • Cruz-Topete, D.; Cidlowski, J. A. One Hormone Two Actions: Anti- and Pro-Inflammatory Effects of Glucocorticoids. Neuroimmunomodulation 2015, 22, 20–32. DOI: 10.1159/000362724.
  • Haneef, J.; Shaharyar, M.; Husain, A.; Rashid, M.; Mishra, R.; Parveen, S.; Ahmed, N.; Pal, M.; Kumar, D. Application of LC-MS/MS for Quantitative Analysis of Glucocorticoids and Stimulants in Biological Fluids . J. Pharm. Anal. 2013, 3, 341–348. DOI: 10.1016/j.jpha.2013.03.005.
  • Marti, C. Adjunctive Corticotherapy for Community Acquired Pneumonia: A Systematic Review and Meta-Analysis. PLoS One 2015, 10, 1–15.
  • Quax, R. A.; Manenschijn, L.; Koper, J. W.; Hazes, J. M.; Lamberts, S. W. J.; van Rossum, E. F. C.; Feelders, R. A. Glucocorticoid Sensitivity in Health and Disease. Nat. Rev. Endocrinol. 2013, 9, 670–686. DOI: 10.1038/nrendo.2013.183.
  • Broersen, L. H. A.; Pereira, A. M.; Jørgensen, J. O. L.; Dekkers, O. M. Adrenal Insufficiency in Corticosteroids Use: Systematic Review and Meta-Analysis. J. Clin. Endocrinol. Metab. 2015, 100, 2171–2180. DOI: 10.1210/jc.2015-1218.
  • Buttgereit, F.; Wehling, M.; Burmester, G. R. A New Hypothesis of Modular Glucocorticoid Actions: Steroid Treatment of Rheumatic Diseases Revisited. Arthritis Rheum. 1998, 41, 761–767. DOI: 10.1002/1529-0131(199805)41:5<761::AID-ART2>3.0.CO;2-M.
  • Miehlke, S. Oral Budesonide in Gastrointestinal and Liver Disease: A Practical Guide for the Clinician. J. Gastroenterol. Hepatol. 2018, 33, 1574–1581.
  • Barnes, P. J. Glucocorticoids. Chem. Immunol. Allergy 2014, 100, 311–316. DOI: 10.1159/000359984.
  • Brasil, M. d S. Agência Nacional de Vigilância Sanitária (ANVISA). 2018. http://portal.anvisa.gov.br/wps/content/Anvisa+Portal/Anvisa/Inicio/medicamentos/Assunto+de+Interesse/Medicamentos+de+referencia (accessed June 09, 2018).
  • Palacius, R.; Sugawara, I. Hydrocortisone Abrogates Proliferation of T Cells in Autologous Mixed Lymphocyte Reaction by Rendering the Interleukin-2 Producer T Cells Unresponsive to Interleukin-1 and Unable to Synthesize the T-Cell Growth Factor. Scand. J. Immunol. 1982, 15, 25–31. DOI: 10.1111/j.1365-3083.1982.tb00618.x.
  • Derendorf, H. Pharmacokinetics and Pharmacodynamics of Inhaled Corticosteroids. J. Allergy Clin. Immunol. 1998, 101, 4.
  • European Comission Public Health. 2011. https://ec.europa.eu/health/home_en. (accessed July 25, 2018).
  • Varoni, E. M.; Molteni, A.; Sardella, A.; Carrassi, A.; Di Candia, D.; Gigli, F.; Lodi, F.; Lodi, G. Pharmacokinetics Study About Topical Clobetasol on Oral Mucosa. J. Oral Pathol. Med. 2012, 41, 255–260. DOI: 10.1111/j.1600-0714.2011.01087.x.
  • Nozaki, O. Steroid Analysis for Medical Diagnosis. J. Chromatogr. A 2001, 935, 267–278.
  • Polito, A.; Hamitouche, N.; Ribot, M.; Polito, A.; Laviolle, B.; Bellissant, E.; Annane, D.; Alvarez, J.-C. Pharmacokinetics of Oral Fludrocortisone in Septic Shock. Br. J. Clin. Pharmacol. 2016, 82, 1509–1516. DOI: 10.1111/bcp.13065.
  • Daley–Yates, P. T. Inhaled Corticosteroids: Potency, Dose Equivalence and Therapeutic Index. Br. J. Clin. Pharmacol. 2015, 80, 372–380.
  • Sastre, J.; Mosges, R. Local and Systemic Safety of Intranasal Corticosteroids. J. Investig. Allergol. Clin. Immunol. 2012, 22, 1–12.
  • Chen, D.; Tao, Y.; Liu, Z.; Zhang, H.; Liu, Z.; Wang, Y.; Huang, L.; Pan, Y.; Peng, D.; Dai, M.; et al. Development of a Liquid Chromatography-Tandem Mass Spectrometry with Pressurized Liquid Extraction for Determination of Glucocorticoid Residues in Edible Tissues. J. Chromatogr. B 2011, 879, 174–180. DOI: 10.1016/j.jchromb.2010.11.039.
  • Dusi, G.; Gasparini, M.; Curatolo, M.; Assini, W.; Bozzoni, E.; Tognoli, N.; Ferretti, E. Development and Validation of a Liquid Chromatography–Tandem Mass Spectrometry Method for the Simultaneous Determination of Nine Corticosteroid Residues in Bovine Liver Samples. Anal. Chim. Acta 2011, 700, 49–57. DOI: 10.1016/j.aca.2011.01.011.
  • Coelho, A. L.; Aucélio, R. Q. Photochemical Induced Fluorescence for the Determination of Prednisolone and Triamcinolone. J. Anal. Lett. 2006, 39, 619–630. DOI: 10.1080/00032710500536095.
  • Romanholi, D. J. P. C.; Salgado, L. R. Síndrome de Cushing Exógena e Retirada Dos Glicocorticoides. Arq. Bras. Endocrinol. Metab. 2007, 51, 1280–1292.
  • Toralles, M. B. P. A Ação Das Isoenzimas 11β − hidroxiesteroide Desidrogenase Tipo 1 e Tipo 2 na Patogênese da Síndrome de Cushing. Rev. Bras. Promoç. Saúde. 2007, 20, 104–110. DOI: 10.5020/18061230.2007.p104.
  • Chemspider. http://www.chemspider.com. (accessed July 25, 2018).
  • Lewis, R. J. Hawley's Condensed Chemical Dictionary, 16th ed.; Wiley: New York, 2016.
  • Cisternino, S.; Schlatter, J.; Saulnier, J. L. Stability of Fludrocortisone Acetate Solutions Prepared from Tablets and Powder. Eur. J. Pharm. Biopharm. 2003, 5, 209–213. DOI: 10.1016/S0939-6411(02)00159-5.
  • Zheng, J.; Patel, D.; Tang, Q.; Markovich, R. J.; Rustum, A. M. Comparison Study of Porous, Fused-Core, and Monolithic Silica-Based C18 HPLC Columns for Celestoderm-V Ointment® Analysis. J. Pharm. Biomed. Anal. 2009, 50, 815–822. DOI: 10.1016/j.jpba.2009.06.042.
  • Adi-Dako, O.; Oppong, B. S.; Ofori-Kwakye, K.; Appiah, E.; Peprah, P. Novel HPLC Analysis of Hydrocortisone in Conventional and Controlled-Release Pharmaceutical Preparations. Int. J. Pharm. 2017, June, 1–8.
  • D'Hondt, M.; Wynendaele, E.; Vandercruyssen, K.; Bauters, T.; Vandenbroucke, J.; Mullens, S.; Vervaet, C.; Remon, J. P.; De Spiegeleer, B. Investigation of Active Pharmaceutical Ingredient Loss in Pharmaceutical Compounding of Capsules. J. Pharm. Biomed. Anal. 2014, 96, 68–76. DOI: 10.1016/j.jpba.2014.03.020.
  • Zivanovic, L.; Zecevic, M.; Markovic, S.; Petrovic, S.; Ivanovic, I. Validation of Liquid Chromatographic Method for Analysis of Lidocaine Hydrochloride, Dexamethasone Acetate, Calcium Dobesilate, Buthylhydroxyanisol and Degradation Product Hydroquinone in Suppositories and Ointment. J. Chromatogr. A 2005, 1088, 182–186. DOI: 10.1016/j.chroma.2005.04.049.
  • Dyderski, S.; Grześkowiak, E.; Szałek, E.; Mrzygłód, A. Pharmaceutical Availability of Clobetasol-17-Propionate from Cream and Ointment. Acta Pol. Pharm. 2001, 58, 435–438.
  • Shou, M.; Galinada, W. A.; Wei, Y.-C.; Tang, Q.; Markovich, R. J.; Rustum, A. M. Development and Validation of a Stability-Indicating HPLC Method for Simultaneous Determination of Salicylic Acid, Betamethasone Dipropionate and Their Related Compounds in Diprosalic Lotion®. J. Pharm. Biomed. Anal. 2009, 50, 356–361. DOI: 10.1016/j.jpba.2009.05.015.
  • Gupta, M.; Bhargava, H. N. Development and Validation of a High-Performance Liquid Chromatographic Method for the Analysis of Budesonide. J. Pharm. Biomed. Anal. 2006, 40, 423–428. DOI: 10.1016/j.jpba.2005.06.038.
  • Hou, S.; Hindle, M.; Byron, P. R. A Stability-Indicating HPLC Assay Method for Budesonide. J. Pharm. Biomed. Anal. 2001, 24, 371–380.
  • Badili, U.; Sen, T.; Tarimci, N. Microparticulate Based Topical Delivery System of Clobetasol Propionate. AAPS Pharm. Sci. Tech. 2011, 12, 949–957.
  • Smits, E. A. W.; Smits, C. J. P.; Vromans, H. The Development of a Method to Quantify Encapsulated and Free Prednisolone Phosphate in Liposomal Formulations. J. Pharm. Biomed. Anal. 2013, 75, 47–54. DOI: 10.1016/j.jpba.2012.11.008.
  • Araújo, J.; Gonzalez-Mira, E.; Egea, M. A.; Garcia, M. L. Souto, E.B. Optimization and Physicochemical Characterization of a Triamcinolone Acetonide-Loaded NLC for Ocular Antiangiogenic Applications. Int. J. Pharm. 2010, 393, 167–175.
  • el-Yazbi, F. A.; Korany, M. A.; Abdel-Razak, O.; Elsayed, M. A. Derivative Spectrophotometric Determination of Some Corticosteroids in Combinations with Other Drugs. J. Assoc. Off. Anal. Chem. 1986, 69, 614–618.
  • Bassuoni, Y. F.; Elzanfaly, E. S.; Essam, H. M.; Zaazaa, H. E.-S. Development and Validation of Stability Indicating TLC Densitometric and Spectrophotometric Methods for Determination of Clobetasol Propionate. Bull. Fac. Sci. Cairo Univ. 2016, 54, 165–174. DOI: 10.1016/j.bfopcu.2016.05.001.
  • Mostafa, A. A.; Bebawy, L. I.; Refaat, H. H. Spectrophotometric Determination of Clobetasol Propionate, Halobetasol Propionate, Quinagolide Hydrochloride, Through Charge Transfer Complexation. J. Pharm. Biomed. Anal. 2002, 27, 889–899.
  • Nagaich, U.; Gulati, N. Nanostructured Lipid Carriers (NLC) Based Controlled Release Topical Gel of Clobetasol Propionate: Design and In Vivo Characterization. Drug Deliv. Transl. Res. 2016, 6, 289–298. DOI: 10.1007/s13346-016-0291-1.
  • Deng, G.; Ashley, A. J.; Brown, W. E.; Eaton, J. W.; Hauck, W. W.; Kikwai, L. C.; Liddell, M. R.; Manning, R. G.; Munoz, J. M.; Nithyanandan, P.; et al. The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance. Pharm. Res. 2008, 25, 100–1109.
  • Giovagnoli, S.; Blasi, P.; Ricci, M.; Schoubben, A.; Perioli, L.; Rossi, C. Physicochemical Characterization and Release Mechanism of a Novel Prednisone Biodegradable Microsphere Formulation. J. Pharm. Sci. 2008, 97, 303–317. DOI: 10.1002/jps.21073.
  • Seeger, N.; Lange, S.; Klein, S. Impact of Vibration and Agitation Speed on Dissolution of USP Prednisone Tablets RS and Various IR Tablet Formulations. AAPS. PharmSciTech 2015, 16, 759–766. DOI: 10.1208/s12249-015-0356-3.
  • Brniak, W.; Maślak, E.; Jachowicz, R. Orodispersible Films and Tablets with Prednisolone Microparticles. Eur. J. Pharm. Sci. 2015, 75, 81–90. DOI: 10.1016/j.ejps.2015.04.006.
  • Sadia, M.; Sośnicka, A.; Arafat, B.; Isreb, A.; Ahmed, W.; Kelarakis, A.; Alhnan, M. A. Adaptation of Pharmaceutical Excipients to FDM 3D Printing for the Fabrication of Patient-Tailored Immediate Release Tablets. Int. J. Pharm. 2016, 513, 659–668. DOI: 10.1016/j.ijpharm.2016.09.050.
  • Saad, A. S. Novel Spectrophotometric Method for Selective Determination of Compounds in Ternary Mixtures (Dual Wavelength in Ratio Spectra). Spectrochim. Acta. A Mol. Biomol. Spectrosc. 2015, 147, 257–261. DOI: 10.1016/j.saa.2015.03.095.
  • Lotfy, H. M.; Tawakkol, S. M.; Fahmy, N. M.; Shehata, M. A. Sucessive Spectrophotometric Resolution as a Novel Technique for the Analysis of Ternary Mixtures of Pharmaceuticals. Spectrochim. Acta A Mol. Biomol. Spectrosc. 2014, 121, 313–323. DOI: 10.1016/j.saa.2013.10.090.
  • Mostafa, N. M.; Elsayed, G. M.; Hassan, N. Y.; El Mously, D. A. Development and Validation of Eco-Friendly Liquid Chromatographic and Spectrophotometric Methods for Simultaneous Determination of Coformulated Drugs: Phenylephrine Hydrochloride and Prednisolone Acetate. J. AOAC Int. 2017, 100, 1761–1770. DOI: 10.5740/jaoacint.17-0001.
  • Cardoso, S. G.; Correa, G. M.; Bellé, L. P. Desenvolvimento e Validação de Método de Dissolução Para Deflazacorte em Comprimidos e Cápsulas Magistrais. Lat. Am. J. Pharm. 2008, 27, 734–739.
  • Hegazy, M. A.; Lotfy, H. M.; Rezk, M. R.; Omran, Y. R. Novel Spectrophotometric Determination of Chloramphenicol and Dexamethasone in the Presence of Non Labeled Interfering Substances Using Univariate Methods and Multivariate Regression Model Updating. Spectrochim. Acta A Mol. Biomol. Spectrosc. 2015, 140, 600–613. DOI: 10.1016/j.saa.2014.12.098.
  • Abdel-Aleem, E. A.; Hegazy, M. A.; Sayed, N. W.; Abdelkawy, M.; Abdelfatah, R. M. Novel Spectrophotometric Determination of Flumethasone Pivalate and Clioquinol in Their Binary Mixture and Pharmaceutical Formulation. Spectrochim. Acta A Mol. Biomol. Spectrosc. 2015, 136, 707–713. DOI: 10.1016/j.saa.2014.09.085.
  • Lam, P.-L.; Lee, K. K.-H.; Wong, R. S.-M.; Cheng, G. Y. M.; Cheng, S. Y.; Yuen, M. C.-W.; Lam, K.-H.; Gambari, R.; Kok, S. H.-L.; Chui, C.-H.; et al. Development of Hydrocortisone Succinic Acid/and 5-Fluorouracil/Chitosan Microcapsules for Oral and Topical Drug Deliveries. Bioorg. Med. Chem. Lett. 2012, 22, 3213–3218.
  • Singh, D. K.; Verma, R. Comparison of Second Derivative-Spectrophotometric and Reversed-Phase HPLC Methods for the Determination of Prednisolone in Pharmaceutical Formulations. Anal. Sci. 2007, 23, 1241–1243. DOI: 10.2116/analsci.23.1241.
  • Sversut, R. A.; Alcântara, I. C.; Rosa, A. M.; Baroni, A. C. M.; Rodrigues, P. O.; Singh, A. K.; Amaral, M. S.; Kassab, N. M. Simultaneous Determination of Gatifloxacin and Prednisolone Acetate in Ophthalmic Formulation Using First-Order UV Derivative Spectroscopy. Arabian J. Chem. 2017, 10, 604–610. DOI: 10.1016/j.arabjc.2014.11.026.
  • Hájková, R.; Solich, P.; Dvořák, J.; Šı́cha, J. Simultaneous Determination of Methylparaben, Propylparaben, Hydrocortisone Acetate and Its Degradation Products in a Topical Cream by RP-HPLC. J. Pharm. Biomed. Anal. 2003, 32, 921–927. DOI: 10.1016/S0731-7085(03)00193-6.
  • Pendella, M. Simultaneous Determination of Lidocaine Hydrochloride, Hydrocortisone and Nystatin in a Pharmaceutical Preparation by RP-LC. J. Pharm. Biomed. Anal. 2011, 56, 641–644.
  • Gibaud, S.; Jabir Al Awwadi, N.; Ducki, C.; Astier, A. Poly (ε-Caprolactone) and Eudragit® Microparticles Containing Fludrocortisone Acetate. Int. J. Pharm. 2004, 269, 491–508. DOI: 10.1016/j.ijpharm.2003.09.040.
  • Ceschell, G. C.; Maffei, P.; Lombardi Borgia, S.; Ronchi, C. Design and Evaluation of Buccal Adhesive Hydrocortisone Acetate (HCA) Tablets. Drug Deliv. 2008, 8, 161–171.
  • Lu, J.; Wei, Y.; Rustum, A. M. A Stability-Indicating Reversed-Phase High Performance Liquid Chromatography Method for Simultaneous Assay of Two Corticosteroids and Estimation of Their Related Compounds in a Pharmaceutical Injectable Formulation. J. Chromatogr. A 2010, 1217, 6932–6941. DOI: 10.1016/j.chroma.2010.08.074.
  • Johnston, S. E.; Gill, N. L.; Wei, Y.-C.; Markovich, R.; Rustum, A. M. Development and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Assay of Betamethasone Dipropionate, Chlorocresol, and for the Estimation of Betamethasone Dipropionate Related Compounds in a Pharmaceutical Cream and Ointment. J. Chromatogr. Sci. 2010, 48, 733–741. DOI: 10.1093/chromsci/48.9.733.
  • Byrne, J.; Velasco-Torrijos, T.; Reinhard, R. Development and Validation of a Novel Stability-Indicating HPLC Method for the Simultaneous Assay of Betamethasone-17-Valerate, Fusidic Acid, Potassium Sorbate, Methylparaben and Propylparaben in a Topical Cream Preparation. J. Pharm. Biomed. Anal. 2014, 96, 111–117. DOI: 10.1016/j.jpba.2014.03.005.
  • El-Gendy, N.; Gorman, E. M.; Munson, E. J.; Berkland, C. Budesonide Nanoparticle Agglomerates as Dry Powder Aerosols with Rapid Dissolution. J. Pharm. Sci. 2009, 98, 2731–2746. DOI: 10.1002/jps.21630.
  • Liu, Y.; Zhou, H. Budesonide-Loaded Guar Gum Microspheres for Colon Delivery: preparation, Characterization and In Vitro/In Vivo Evaluation. Int. J. Mol. Sci. 2015, 16, 2693–2704.
  • Mezzena, M.; Scalia, S.; Young, P. M.; Traini, D. Solid Lipid Budesonide Microparticles for Controlled Release Inhalation Therapy. AAPS J. 2009, 11, 771–778. DOI: 10.1208/s12248-009-9148-6.
  • Yamamoto, Y.; Fukami, T.; Koide, T.; Onuki, Y.; Suzuki, T.; Metori, K.; Katori, N.; Hiyama, Y.; Tomono, K. Comparative Pharmaceutical Evaluation of Brand and Generic Clobetasone Butyrate Ointments. Int. J. Pharm. 2014, 463, 62–67. DOI: 10.1016/j.ijpharm.2013.12.054.
  • Senyigit, T.; Sonvico, F.; Barbieri, S.; Ozer, O.; Santi, P.; Colombo, P. Lecithin/Chitosan Nanoparticles of Clobetasol-17-Propionate Capable of Accumulation in Pig Skin. J. Control. Release 2010, 142, 368–373.
  • Fauzee, A. F.; Walker, R. B. Forced Degradation Studies of Clobetasol 17-Propionate in Methanol, Propylene Glycol, as Bulk Drug and Cream Formulations by RP-HPLC. J. Sep. Sci. 2013, 36, 849–856. DOI: 10.1002/jssc.201200969.
  • Patel, H. K.; Barot, B. S.; Parejiya, P. B.; Shelat, P. K.; Shukla, A. Topical Delivery of Clobetasol Propionate Loaded Microemulsion Based Gel for Effective Treatment of Vitiligo: Ex Vivo Permeation and Skin Irritation Studies. Colloids Surf. B Biointerfaces 2013, 1, 86–94. DOI: 10.1016/j.colsurfb.2012.08.011.
  • Senyigit, T.; Padula, C.; Ozer, O.; Santi, P. Different Approaches for Improving Skin Accumulation of Topical Corticosteroids. Int. J. Pharm. 2009, 380, 155–160.
  • Höller, S.; Valenta, C. Effect of Selected Fluorinated Drugs in a ‘‘Ringing’’ Gel on Rheological Behaviour and Skin Permeation. Eur. J. Pharm. Biopharm. 2007, 66, 120–126. DOI: 10.1016/j.ejpb.2006.08.019.
  • Nagelreiter, C.; Raffeiner, S.; Geyerhofer, C.; Klang, V.; Valenta, C. Influence of Drug Content, Type of Semi-Solid Vehicle and Rheological Properties on the Skin Penetration of the Model Drug Fludrocortisone Acetate. Int. J. Pharm. 2013, 448, 305–312. DOI: 10.1016/j.ijpharm.2013.03.042.
  • RazzaqS, N. Stability Indicating HPLC Method for the Simultaneous Determination of Moxifloxacin and Prednisolone in Pharmaceutical Formulations. Chem. Cent. J. 2012, 6, 1–10.
  • Skowyra, J.; Pietrzak, K.; Alhnan, M. A. Fabrication of Extended-Release Patient-Tailored Prednisolone Tablets Via Fused Deposition Modelling (FDM) 3D Printing. Eur. J. Pharm. Sci. 2015, 68, 11–17. DOI: 10.1016/j.ejps.2014.11.009.
  • Satínký, D.; Chocholous, P.; Salabová, M.; Solich, P. Simple Determination of Betamethasone and Chloramphenicol in a Pharmaceutical Preparation Using a Short Monolithic Column Coupled to a Sequential Injection System. J. Sep. Sci. 2006, 29, 2494–2499.
  • Fini, A.; Bergamante, V.; Ceschel, G. C.; Ronchi, C.; De Moraes, C. A. F. Control of Transdermal Permeation of Hydrocortisone Acetate from Hydrophilic and Lipophilic Formulations. AAPS Pharm. Sci. Tech. 2008, 9, 762–768. DOI: 10.1208/s12249-008-9107-z.
  • Giaccone, V.; Polizzotto, G.; Macaluso, A.; Cammilleri, G.; Ferrantelli, V. Determination of Ten Corticosteroids in Illegal Cosmetic Products by a Simple, Rapid, and High-Performance LC-MS/MS Method. Int. J. Anal. Chem. 2017, 2017, 1. DOI: 10.1155/2017/3531649.
  • Gallego, J. M. L.; Arroyo, J. P. Determination of Prednisolone Acetate, sulfacetamide and Phenylefrine in Local Pharmaceutical Preparations by Micellar Electrokinetic Chromatography. J. Pharm. Biomed. Anal. 2003, 31, 873–884.
  • Gallego, J. M. L.; J. P. Micellar Electrokinetic, A. Capillary Chromatography as an Alternative Method for Determination of Hydrocortisone and Its Most Important Associated Compounds in Local Pharmaceutical Preparation. Chromatographia 2002, 56, 455–462.
  • Desmedt, B.; Van Hoeck, E.; Rogiers, V.; Courselle, P.; De Beer, J. O.; De Paepe, K.; Deconinck, E. Characterization of Suspected Illegal Skin Whitening Cosmetics. J. Pharm. Biomed. Anal. 2014, 90, 85–91. DOI: 10.1016/j.jpba.2013.11.024.
  • Taylor, R. L.; Grebe, S. K.; Singh, R. J. Quantitative, highly Sensitive Liquid Chromatography–Tandem Mass Spectrometry Method for Detection of Synthetic Corticosteroids. Clin. Chem. 2004, 50, 2345–2352. DOI: 10.1373/clinchem.2004.033605.
  • Ferraboschi, P.; Bertacche, V.; Maccone, I.; Pini, E.; Ragonesi, L.; Venturini, A.; Stradi, R. Estimation and Characterisation of Budesonide Tablets impurities. J. Pharm. Biomed. Anal. 2008, 47, 636–640. DOI: 10.1016/j.jpba.2008.01.050.
  • Wang, B.; Ni, X.; Yu, M.; Cao, Y. Polymeric Micelle as the Pseudostationary Phase in Electrokinetic Chromatography. J. Chromatogr. A 2012, 1245, 190–198. DOI: 10.1016/j.chroma.2012.05.030.
  • Brombacher, S.; Owen, S. J.; Volmer, D. A. Automated Coupling of Capillary-HPLC to Matrix-Assisted Laser Desorption/Ionization Mass Spectrometry for the Analysis of Small Molecules Utilizing a Reactive Matrix. Anal. Bioanal. Chem. 2003, 376, 773–779. DOI: 10.1007/s00216-003-2024-9.
  • Patel, A. G.; Patel, R. B.; Patel, M. R. Liquid Chromatographic Determination of Clobetasone-17-Butyrate in Ointments. J. Assoc. Off. Anal. Chem. 1990, 73, 893–895.
  • Görög, S. Analysis of Steroids VIII: determination of Conjugated Ketosteroidsin Pharmaceutical Preparations Using the Sodium Brohydride Method. J. Pharm. Sci. 1968, 57, 1737–1741. DOI: 10.1002/jps.2600571023.
  • Graham, R. E.; Williams, P. A.; Kenner, C. T. Detection of Decompositionand Analytical Interferences in Pharmaceutical Preparations Containing Corticosteroids. J. Pharm. Sci. 1970, 59, 1152–1156. DOI: 10.1002/jps.2600590820.
  • Golubovic, J. B. Liquid Chromatography/Tandem Mass Spectrometry for Simultaneous Determination of Undeclared Corticosteroids in Cosmetic Creams. Rapid Commun. Mass Spectrom. 2015, 29, 2319–2327.
  • Dolowy, M.; Kulpinska-Kulcia, K.; Pyka, A. Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation. Sci. World J. 2014, Jan, 1–10.
  • Gallego, J. M. L.; Arroyo, J. P. Comparison of HPLC and Multivariate Regression Methods for Hydrocortisone and Lidocaine Analysis of Pharmaceutical Preparations. Anal. Bioanal. Chem. 2002, 374, 282–288.
  • Rego, A.; Nelson, B. Simultaneous Determination of Hydrocortisone and Benzyl Alcohol in Pharmaceutical Formulations by Reversed-Phase High-Pressure Liquid Chromatography. J. Pharm. Sci. 1982, 71, 1219–1223. DOI: 10.1002/jps.2600711109.
  • Gallego, J. M. L.; Arroyo, J. P. Determination of Prednisolone and the Most Important Associated Compounds in Ocular and Cutaneous Pharmaceutical Preparations by Micellar Electrokinetic Capillary Chromatography. J. Chromatogr. B 2003, 784, 39–47.
  • Blanco, M.; Coello, J.; Iturriaga, H.; Maspoch, S.; Villegas, N. Kinetic Spectrophotometric Determination of Hydrocortisone Acetate in a Pharmaceutical Preparation by Use of Partial Least-Squares Regression. Analyst 1999, 124, 911–915. DOI: 10.1039/a900856j.
  • Korany, M. A.; Maher, H. M.; Galal, S. M.; Ragab, M. A. Development and Optimization of a Capillary Zone Electrophoresis Technique for Simultaneous Determination of Miconazole Nitrate and Hydrocortisone Acetate in a Cream Pharmaceutical Formulation. J. AOAC Int. 2013, 96, 1295–1301. DOI: 10.5740/jaoacint.11-343.
  • Nikolic, K.; Medenica, M.; Bogavac, M.; Arsenijević, L. Chlorocoulometric Determination of Hydrocortisone and Hydrocortisone Acetate. Farmaco 1991, 46, 623–626.
  • Abdou, H. M.; Ast, T. M.; Cioffi, F. J. Semiautomated System for High-Pressure Liquid Chromatographic Determination of Dissolution Rate of Fludrocortisone Acetate Tablets. J. Pharm. Sci. 1978, 67, 1397–1399. DOI: 10.1002/jps.2600671017.
  • Zhang, F.; Zhou, J.; Shi, Y.; Tavlarakis, P.; Karaisz, K. Mechanism Driven Structural Elucidation of Forced Degradation Products from Hydrocortisone in Solution. J. Pharm. Biomed. Anal. 2016, 128, 333–341. DOI: 10.1016/j.jpba.2016.06.004.
  • Walters, M. J. Liquid Chromatographic Determination of Hydrocortisone in Bulk Drug Substance and Tablets: Collaborative Study. J. Assoc. Off. Anal. Chem. 1984, 67, 218–221.
  • Fawcett, J. P.; Boulton, D. W.; Jiang, R.; Woods, D. J. Stability of Hydrocortisone Oral Suspensions Prepared from Tablets and Powder. Ann. Pharmacother. 1995, 29, 987–990. DOI: 10.1177/106002809502901005.
  • Mohamed, F. A. A.; Roberts, M.; Seton, L.; Ford, J. L.; Levina, M.; Rajabi-Siahboomi, A. R. The Influence of HPMC Concentration on Release of Theophylline or Hydrocortisone from Extended Release Mini-Tablets. Drug Dev. Ind. Pharm. 2013, 39, 1167–1174. DOI: 10.3109/03639045.2012.681053.
  • Mohamed, F. A. A.; Roberts, M.; Seton, L.; Ford, J. L.; Levina, M.; Rajabi-Siahboomi, A. R. The Effect of HPMC Particle Size on the Drug Release Rate and the Percolation Threshold in Extended-Release Mini-Tablets. Drug Dev. Ind. Pharm. 2015, 41, 70–78. DOI: 10.3109/03639045.2013.845843.
  • Patel, R. B.; Rogge, M. C.; Selen, A.; Goehl, T. J.; Shah, V. P.; Prasad, V. K.; Welling, P. G. Bioavailability of Hydrocortisone from Commercial 20-Mg Tablets. J. Pharm. Sci. 1984, 73, 964–966.
  • Spireas, S.; Sadu, S.; Grover, R. In Vitro Release Evaluation of Hydrocortisone Liquisolid Tablets. J. Pharm. Sci. 1998, 87, 867–872. DOI: 10.1021/js970346g.
  • Fu, Q.; Shou, M.; Chien, D.; Markovich, R.; Rustum, A. M. Development and Validation of a Stability-Indicating RP-HPLC Method for Assay of Betamethasone and Estimation of Its Related Compounds. J. Pharm. Biomed. Anal. 2010, 51, 617–625. DOI: 10.1016/j.jpba.2009.09.034.
  • Xiong, Y.; Xiao, K. P.; Rustum, A. M. Development and Validation of a Stability-Indicating RP-HPLC Method to Separate Low Levels of Dexamethasone and Other Related Compounds from Betamethasone. J. Pharm. Biomed. Anal. 2009, 49, 646–654. DOI: 10.1016/j.jpba.2008.12.023.
  • Arthur, K. E.; Wolff, J. C.; CarrieR, D. J. Analysis of Betamethasone, dexamethasone and Related Compounds by Liquid Chromatography/electrospray Mass Spectrometry. Rapid Commun. Mass Spectrom. 2004, 18, 678–684. DOI: 10.1002/rcm.1386.
  • Jin, P.; Liang, X.; Wu, X.; He, X.; Kuang, Y.; Hu, X. Screening and Quantification of 18 Glucocorticoid Adulterants from Herbal Pharmaceuticals and Health Foods by HPLC and Confirmed by LC-Q-TOF-MS/MS. J. Food Addit. Contam. A Chem. Anal.Control Expo. Risk Assess. 2018, 35, 10–19. DOI: 10.1080/19440049.2017.1400184.
  • Roth, G.; Wikby, A.; Nilsson, L.; Thalén, A. High-Performance Liquid Chromatographic Determination of Epimers, Impurities, and Content of the Glucocorticoid Budesonide and Preparation of Primary Standard. J. Pharm. Sci. 1980, 69, 766–770. DOI: 10.1002/jps.2600690705.
  • Varshosaz, J.; Emami, J.; Tavakoli, N.; Minaiyan, M.; Rahmani, N.; Dorkoosh, F. Development and Evaluation of a Novel Pellet-Based Tablet System for Potential Colon Delivery of Budesonide. J. Drug. Deliv. 2012, 2012, 1. DOI: 10.1155/2012/905191.
  • Varshosaz, J. Development and Validation of a Rapid HPLC Method for Simultaneous Analysis of Budesonide and Its Novel Synthesized Hemiesters in Colon Specific Formulations. Res. Pharm. Sci. 2011, 6, 107–116.
  • Burges, C. Rapid Reversed-Phase High-Performance Liquid Chromatographic Analysis of Steroid Products. J. Chromatogr. 1978, 149, 233–240.
  • Dewani, A. P.; Bakal, R. L.; Kokate, P. G.; Chandewar, A. V.; Patra, S. Development of a Single Ion Pair HPLC Method for Analysis of Terbinafine, Ofloxacin, Ornidazole, Clobetasol, and Two Preservatives in a Cream Formulation: Application to In Vitro Drug Release in Topical Simulated Media-Phosphate Buffer Through Rat Skin. J. AOAC Int. 2015, 98, 913–920. DOI: 10.5740/jaoacint.14-189.
  • Fontana, M. C.; Bastos, M. O.; Beck, R. C. Development and Validation of a Fast RP-HPLC Method for the Determination of Clobetasol Propionate in Topical Nanocapsule Suspensions. J. Chromatogr. Sci. 2010, 48, 637–640. DOI: 10.1093/chromsci/48.8.637.
  • Antignac, J.-P.; Le Bizec, B.; Monteau, F.; Poulain, F.; André, F. Collision-Induced Dissociation of Corticosteroids in Electrospray Tandem Mass Spectrometry and Development of a Screening Method by High Performance Liquid Chromatography/tandem Mass Spectrometry. Rapid Commun. Mass Spectrom. 2000, 14, 33–39. DOI: 10.1002/(SICI)1097-0231(20000115)14:1<33::AID-RCM829>3.3.CO;2-I.
  • Dettlaff, K. M. B.; Bafeltowska, J. The Effect of Fluorine Substituent on Radiochemical Stability of Some Steroid and Azole Derivatives. Ann. Acad. Med. Stetin. 2004, 50, 77–82.
  • Özkan, Y.; Savaşer, A.; Taş, Ç.; Uslu, B.; Özkan, S. A. Drug Dissolution Studies and Determination of Deflazacort in Pharmaceutical Formulations and Human Serum Samples by RP‐HPLC. J. Liq. Chromatogr. Relat. Technol. 2003, 26, 2141–2156. DOI: 10.1081/JLC-120022399.
  • Deshmukh, R.; Sharma, L.; Tekade, M.; Kesharwani, P.; Trivedi, P.; Tekade, R. K. Force Degradation Behavior of Glucocorticoid Deflazacort by UPLC: Isolation, Identification and Characterization of Degradant by FTIR, NMR and Mass Analysis. J. Biomed. Res. 2016, 30, 149–161.
  • Kassuha, D. E.; Aiassa, V.; Bruno, F. P.; Cuadra, G.; Sperandeo, N. R. Preparation and Characterization of Polymorphs of the Glucocorticoid Deflazacort. Pharm. Dev. Technol. 2015, 20, 401–409. DOI: 10.3109/10837450.2013.871033.
  • Paulino, A. S.; Rauber, G.; Campos, C. E. M.; Maurício, M. H. P.; de Avillez, R. R.; Capobianco, G.; Cardoso, S. G.; Cuffini, S. L. Dissolution Enhancement of Deflazacort Using Hollow Crystals Prepared by Antisolvent Crystallization Process. Eur. J. Pharm. Sci. 2013, 49, 294–301. DOI: 10.1016/j.ejps.2013.03.014.
  • Paulino, A. S.; Rauber, G.; Deobald, A. M.; Paulino, N.; Sawaya, A. C. H. F.; Eberlin, M. N.; Cardoso, S. G. Isolation and Characterization of a Degradation Product of Deflazacort. Pharmazie 2012, 67, 495–499.
  • Sperandeo, N. R.; Kassuha, D. E. Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets. Sci. Pharm. 2009, 77, 679–693. DOI: 10.3797/scipharm.0904-05.
  • Cox, D. C.; Furman, W. B. Systematic Error Associated with Apparatus 2 of the USP Dissolution Test V: Interaction of Two Tableted Prednisone Formulations with Glass and Plastic Vessels. J. Pharm. Sci. 1984, 73, 1125–1127. DOI: 10.1002/jps.2600730825.
  • Gupta, V. D. High-Pressure Liquid Chromatographic Evaluation of Aqueous Vehicles for Preparation of Prednisolone and Prednisone Liquid Dosage Forms. J. Pharm. Sci. 1979, 68, 908–910. DOI: 10.1002/jps.2600680734.
  • Leonardi, D.; Salomon, C. J. Influence of Water Uptake, gel Network, and Disintegration Time on Prednisone Release from Encapsulated Solid Dispersions. Pharm. Dev. Technol. 2010, 15, 184–191.
  • Junior, A. A. S. Thermal Behavior and Stability of Biodegradable Spray-Dried Microparticles Containing Triamcinolone. Int. J. Pharm. 2009, 368, 45–55.
  • Korodi, T.; Lachmann, B.; Kopelent-Frank, H. Evaluation of Different Preparation Methods for a Preservative Free Triamcinolone Acetonide Preparation for Intravitreal Administration: A Validated Stability Indicating HPLC-Method. Pharmazie 2010, 65, 860–866.
  • Saadat, E.; Shakor, N.; Gholami, M.; Dorkoosh, F. A. Hyaluronic Acid Based Micelle for Articular Delivery of Triamcinolone, Preparation, In Vitro and In Vivo Evaluation. Int. J. Pharm. 2015, 489, 218–225. DOI: 10.1016/j.ijpharm.2015.05.001.
  • Sheshala, R.; Hong, G. C.; Yee, W. P.; Meka, V. S.; Thakur, R. R. S. In Situ Forming Phase-Inversion Implants for Sustained Ocular Delivery of Triamcinolone Acetonide. Drug Del. Transl. Res. 2018, Feb. 1–9.
  • Ast, T. M.; Abdou, H. M. Analysis of Fludrocortisone Acetate and Its Solid Dosage Forms by High-Performance Liquid Chromatography. J. Pharm. Sci. 1979, 68, 421–423. DOI: 10.1002/jps.2600680407.
  • Johannson, G. Improving Glucocorticoid Replacement Therapy Using a Novel Modified-Release Hydrocortisone Tablet: A Pharmacokinetic Study. Eur. J. Endocrinol. 2009, 161, 119–130.
  • Amer, M. M.; Hassan, S. M.; Aboulkheir, A.; Mostafa, A. A. Application of Orthogonal Functions to the Determination of Prednisolone and Hydrocortisone in Some Pharmaceutical Preparations. Pharmazie 1978, 33, 344–346.
  • Friciu, M.; Plourde, K.; Leclair, G.; Danopoulos, P.; Savji, T. Stability of Prednisone in Oral Mix Suspending Vehicle. Int. J. Pharm. Compd. 2015, 19, 337–339.

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