DEVELOPMENT OF A SPECTROPHOTOMETRIC DETERMINATION OF PREDNISOLONE IN DIFFERENT DOSAGE FORMS
Main Article Content
Abstract
A sensitive, accurate, and affordable colorimetric method was developed for assaying prednisolone (PRZ) in various medicinal forms. The procedure involves the oxidation of PRZ by ferric ions, followed by complexation of the resulting ferrous ions with ferricyanide to produce a greenish-blue product. Common complexation conditions were thoroughly investigated. The mole ratio of FeCl₃·6H₂O to K₃Fe(CN)₆ was 8:1. The proposed mechanism of complexation was suggested and considered. Various parameters were optimized, including the reduction of the colorimetric reaction temperature to 50°C and the duration of heating and analysis to 20-30 minutes. The calibration curve was linear over the range of 1-60 µg/mL. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.5 μg/mL and 1 μg/mL, respectively. Spiking actual samples with standard PRZ showed recoveries within the 97.3-100.1% range. The method exhibited high precision, with an RSD% of less than 1.5%. Additionally, the study confirmed that common pharmaceutical excipients did not interfere. Real medicinal samples, including tablets, syrup, eye drops, and creams, were successfully examined for direct analysis of PRZ using the developed methodology, demonstrating its suitability for routine analysis of various PRZ-containing drug formulations.
Downloads
Article Details
Transfer of Copyrights
- In the event of publication of the manuscript entitled [INSERT MANUSCRIPT TITLE AND REF NO.] in the Malaysian Journal of Science, I hereby transfer copyrights of the manuscript title, abstract and contents to the Malaysian Journal of Science and the Faculty of Science, University of Malaya (as the publisher) for the full legal term of copyright and any renewals thereof throughout the world in any format, and any media for communication.
Conditions of Publication
- I hereby state that this manuscript to be published is an original work, unpublished in any form prior and I have obtained the necessary permission for the reproduction (or am the owner) of any images, illustrations, tables, charts, figures, maps, photographs and other visual materials of whom the copyrights is owned by a third party.
- This manuscript contains no statements that are contradictory to the relevant local and international laws or that infringes on the rights of others.
- I agree to indemnify the Malaysian Journal of Science and the Faculty of Science, University of Malaya (as the publisher) in the event of any claims that arise in regards to the above conditions and assume full liability on the published manuscript.
Reviewer’s Responsibilities
- Reviewers must treat the manuscripts received for reviewing process as confidential. It must not be shown or discussed with others without the authorization from the editor of MJS.
- Reviewers assigned must not have conflicts of interest with respect to the original work, the authors of the article or the research funding.
- Reviewers should judge or evaluate the manuscripts objective as possible. The feedback from the reviewers should be express clearly with supporting arguments.
- If the assigned reviewer considers themselves not able to complete the review of the manuscript, they must communicate with the editor, so that the manuscript could be sent to another suitable reviewer.
Copyright: Rights of the Author(s)
- Effective 2007, it will become the policy of the Malaysian Journal of Science (published by the Faculty of Science, University of Malaya) to obtain copyrights of all manuscripts published. This is to facilitate:
(a) Protection against copyright infringement of the manuscript through copyright breaches or piracy.
(b) Timely handling of reproduction requests from authorized third parties that are addressed directly to the Faculty of Science, University of Malaya. - As the author, you may publish the fore-mentioned manuscript, whole or any part thereof, provided acknowledgement regarding copyright notice and reference to first publication in the Malaysian Journal of Science and Faculty of Science, University of Malaya (as the publishers) are given.
You may produce copies of your manuscript, whole or any part thereof, for teaching purposes or to be provided, on individual basis, to fellow researchers. - You may include the fore-mentioned manuscript, whole or any part thereof, electronically on a secure network at your affiliated institution, provided acknowledgement regarding copyright notice and reference to first publication in the Malaysian Journal of Science and Faculty of Science, University of Malaya (as the publishers) are given.
- You may include the fore-mentioned manuscript, whole or any part thereof, on the World Wide Web, provided acknowledgement regarding copyright notice and reference to first publication in the Malaysian Journal of Science and Faculty of Science, University of Malaya (as the publishers) are given.
- In the event that your manuscript, whole or any part thereof, has been requested to be reproduced, for any purpose or in any form approved by the Malaysian Journal of Science and Faculty of Science, University of Malaya (as the publishers), you will be informed. It is requested that any changes to your contact details (especially e-mail addresses) are made known.
Copyright: Role and responsibility of the Author(s)
- In the event of the manuscript to be published in the Malaysian Journal of Science contains materials copyrighted to others prior, it is the responsibility of current author(s) to obtain written permission from the copyright owner or owners.
- This written permission should be submitted with the proof-copy of the manuscript to be published in the Malaysian Journal of Science
References
Abdul Kareem, R. Q., & Al-Janabi, K. W. S. (2018). Determination of the Degree of Consumption (DoC) of Lube Engine Oils Using Fluorescence Spectroscopy. Ibn AL- Haitham Journal For Pure and Applied Science, 31(1), 124. https://doi.org/10.30526/31.1.1860.
Albayati, T. M., & Jassam, A. A. A. (2019). Synthesis and characterization of mesoporous materials as a carrier and release of prednisolone in drug delivery system. Journal of Drug Delivery Science and Technology, 53, 101176. https://doi.org/10.1016/j.jddst.2019.101176.
Ali, A. S., & Rasheed, A. S. (2020). Application of hydrophilic interaction chromatography methods for prednisolone acetate determination in their pure and tablet, syrup dosage forms. Plant Archives, 20(1), 2807–2812. http://plantarchives.org/20-1/2807-2812%20(6042).pdf.
Al-Janabi, K. W. S. (2013). Quantification of Acrylamide content in Potato Chips and Iraqi “Harissa.” Ibn Al-Haitham Journal for Pure and Applied Sciences, 26(3), 236–244.
Al-Janabi, K. W. S., Mahmood, A. K., & Luaibi, H. M. (2020a). Determination of the Dissociation Constants of Metformin from a Second Derivative UV Spectrum. International Journal of Research in Pharmaceutical Sciences, 11(1), 790–796. https://pharmascope.org/index.php/ijrps/article/view/1896.
Al-Janabi, K. W. S., Mahmood, A. K., & Luaibi, H. M. (2020b). Development of a simple colorimetric determination of dexamethasone. International Journal of Drug Delivery Technology, 10(2), 255–258. https://doi.org/10.25258/ijddt.10.2.12.
Al-Janabi, K. W. S., Mahmood, A. K., & Luaibi, H. M. (2020c). Quantitative Analysis of Some Aromatic Amino Acids By Spectrophotometric Mathematical Derivatization. Biochemical and Cellular Archives, 20(2), 6435–6439.
Balaji, K., Reddy, G. V. R., Reddy, T. M., & Reddy, S. J. (2008). Determination of prednisolone, dexamethasone and hydrocortisone in pharmaceutical formulations and biological fluid samples by voltammetric techniques using b-cyclodextrin modified carbon paste electrode. African Journal of Pharmacy and Pharmacology, 2(8), 157–166. https://doi.org/https://doi.org/10.5897/AJPP.9000096.
Bhusnure, O. G., Manoj, B., Todkar, V., & Giram, P. S. (2015). Analytical Method Development and Validation of Prednisolone Sodium Phosphate by QbD Approach. IOSR Journal of Pharmacy and Biological Sciences Ver. III, 10(6), 2319–7676. https://doi.org/10.9790/3008-10636475.
Dikran, S. B., Mohammed, A. K., & Mahmood, A. K. (2017). Uni and Multivariate Optimization for the Spectrophotometric Determination of Cimetidine Drug via Charge-Transfer Complex Formation. Ibn AL-Haitham Journal For Pure and Applied Science, 28(3), 113–128.
El Gammal, R. N., Hammouda, M. E. A., El-Wasseef, D. R., & El-Ashry, S. M. (2018). Simultaneous determination of gatifloxacin and prednisolone in their bulk powder, synthetic mixture and their combined ophthalmic preparation using micellar liquid chromatography. Journal of Chromatographic Science, 56(4), 367–374. https://doi.org/10.1093/chromsci/bmy011.
Evtifeeva, O. A., Proskurina, K. I., Ganeva, E. V., & Zhukova, T. V. (2016). Evaluation of Metrological Characteristics for Quantitative Spectrophotometric Determination of Prednisolone by an Optical Absorbance Method. Pharmaceutical Chemistry Journal, 49(12), 847–853. https://doi.org/10.1007/s11094-016-1385-2.
Hammod, N. M., Al-Janabi, K. W. S., & Hasan, S. A. (2020). Determination of some volatile organic compounds in the water produced at al-ahdab oilfield in the governorate of Wasit, Iraq using headspace SPE-GC-FID. Indian Journal of Forensic Medicine and Toxicology, 14(1), 994–999. https://doi.org/10.37506/v14/i1/2020/ijfmt/193034.
Hammod, N. M., Al-janabi, K. W. S., & Hasan, S. A. (2020). TRACKING OF THE EXISTENCE OF POLYCYCLIC AROMATIC HYDROCARBONS ( PAH ) IN WATER RESOURCES AROUND AND AWAY FROM AL-AHDAB OIL FIELD IN WASIT GOVERNORATE OF IRAQ. Plant Archives, 20(2), 5047–5052.
Hannoun, W. A., & Al-Janabi, K. W. S. (2020). Spectrophotometric determination of isopropamide iodide based on ion-pair complex formation with thymol blue. Indian Journal of Forensic Medicine and Toxicology, 14(2), 1043–1049. http://medicopublication.com/index.php/ijfmt/article/view/3045.
Iannella, L., Botrè, F., Colamonici, C., Curcio, D., & de la Torre, X. (2019). Development and validation of a method to confirm the exogenous origin of prednisone and prednisolone by GC-C-IRMS. Drug Testing and Analysis, 11(11–12), 1615–1628. https://doi.org/10.1002/dta.2715.
Kashyap, R., Subrahmanyam, E. V. S., & Sharbaraya, A. R. (2012). Development evelopment and validation of UV spectroscopy method for the estimation of prednisolone in bulk and dosage form. Journal of Chemical and Pharmaceutical Research, 4(2), 1090–1096. https://www.jocpr.com/articles/development-and-validation-of-uv-spectroscopy-method-for-the-estimation-of-prednisolone-in-bulk-and-dosage-form.pdf
Lemus Gallego, J. M., & Pérez Arroyo, J. (2003). Simultaneous Determination of Hydrocortisone and Zn-Bacitracin by Spectrophotometric Derivative and Multivariate Methods. Microchimica Acta, 141(3–4), 133–141. https://doi.org/10.1007/s00604-002-0940-6
Mahmood, A. K. (2017). Development Of Two Different Spectrophotometric Methods For The Determination Of Atropine Drug In Pure Form And Pharmaceutical Preparations. Ibn AL-Haitham Journal For Pure and Applied Science, 25(3), 226–241.
Mortimer, R. J. (2017). Spectroelectrochemistry, Applications. In Encyclopedia of Spectroscopy and Spectrometry (pp. 160–171). Elsevier. https://doi.org/10.1016/B978-0-12-803224-4.00288-0
Primpray, V., Chailapakul, O., Tokeshi, M., Rojanarata, T., & Laiwattanapaisal, W. (2019). A paper-based analytical device coupled with electrochemical detection for the determination of dexamethasone and prednisolone in adulterated traditional medicines. Analytica Chimica Acta, 1078, 16–23. https://doi.org/10.1016/j.aca.2019.05.072.
Radhi, N. A. A., & Al-Janabi, K. W. S. (2020). Spectrophotometric determination of Di phenyl hydramine HCl in pure and pharmaceutical formulations using Thymol blue. Annals of Tropical Medicine and Public Health.
Raut, G. S., Shirkhedkar, A. A., Ugale, V. G., & Surana, S. J. (2014). Simultaneous determination of Prednisolone acetate and Moxifloxacin hydrochloride in bulk and in eye drop using RP-HPTLC. Journal of Liquid Chromatography and Related Technologies, 37(4), 528–537. https://doi.org/10.1080/10826076.2012.749495.
Razzaq, S. N., Ashfaq, M., Khan, I. U., Mariam, I., Razzaq, S. S., & Azeem, W. (2017). Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method. Arabian Journal of Chemistry, 10(3), 321–328. https://doi.org/10.1016/j.arabjc.2014.11.016.
Schuster, D., Laggner, C., & Langer, T. (2005). Why drugs fail-a study on side effects in new chemical entities. Current Pharmaceutical Design, 11(27), 3545–3559.
Singh, D. K., & Verma, R. (2008). Spectrophotometric Determination of Corticosteroids and Its Application in Pharmaceutical Formulation. Iranian Journal of Pharmacology & Therapeutics, 7(1), 61–65. http://ijpt.iums.ac.ir/article-1-155-en.html.
Skoog, D. A., Holler, F. J., & Crouch, S. R. (2017). Principles of Instrumental Analysis. Cengage Learning. https://books.google.iq/books?id=D13EDQAAQBAJ.
Smajdor, J., Piech, R., & Paczosa-bator, B. (2016). A Novel Method of High Sensitive Determination of Prednisolone on Renewable Mercury Film Silver Based Electrode. 394–400. https://doi.org/10.1002/elan.201500262.
Xu, J., Winkler, J., & Derendorf, H. (2007). A pharmacokinetic/pharmacodynamic approach to predict total prednisolone concentrations in human plasma. Journal of Pharmacokinetics and Pharmacodynamics, 34(3), 355–372. https://doi.org/10.1007/s10928-007-9050-8.