VALIDATION OF THE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF DIACEREIN IN THE "DISSOLUTION" TEST OF SOLID GELATIN CAPSULES

Authors

DOI:

https://doi.org/10.11603/2312-0967.2023.4.14116

Keywords:

diacerein, dissolution test, spectrophotometry, quantitative determination, validation characteristics, diacerein, Dissolution test, spectrophotometry, quantitative determination, validation characteristics, linearity., precision, repeatability, specificity

Abstract

The aim of the work is to investigate the validation characteristics of a spectrophotometric method for the dissolution of diacerein from solid gelatin capsules.

Materials and Methods. For the analysis, the following materials were utilized: diacerein of pharmacopoeial quality produced by Taizhou Highsun Pharmaceutical Co., Ltd., China; «Arthrodarin®» capsules, 50 mg, manufactured by TRB PHAR-MA S.A., Argentina. Dissolution studies were conducted in a 6-station paddle apparatus with the use of a phosphate buffer solution with a pH of 6.8. The amount of released diacerein was analyzed using a UV-VIS Lambda 35 spectrophotometer (Perkin Elmer, USA) in 10 mm cuvettes.

Results and Discussion. Validation characteristics were confirmed, including linearity, accuracy, specificity, and precision. The total predicted uncertainty of the analytical method was 1.96%, which did not exceed the acceptable uncertainty limit of 3%. Linearity was established for the quantitative determination of diacerein content in the range of 50% to 140% of the nominal value. The influence of «placebo» background absorption on optical density measurements was minimal, indicating sufficient specificity of the method. Statistical analysis of experimental data revealed a correlation coefficient (r) for the linear relationship between the introduced and found values for the quantitative content of diacerein, which was >0.990, indicating the correctness of the methodology.

Conclusions. A rapid, accurate, and selective method was developed using the sodium acetate component as a hydrotropic substance to increase the solubility of diacerein in a non-aqueous solvent during the spectrophotometric analysis of the determination of diacerein in the "Dissolution" test. The diacerein spectrum exhibited absorption maxima at 343 nm. Linearity for the proposed method  is confirmed in the concentration range of 50-140% of the nominal value. The precision and repeatability as validations criteria are also fulfilled for the proposed method.

Author Biographies

O. O. Saliy, Kyiv National University of Technologies and Design

PhD (Pharmacy) Associate Professor of the Department of Industrial Pharmacy

V. I. Bessarabov, Kyiv National University of Technologies and Design

Doctor of Technical Sciences, Professor, Professor of the Department of Industrial Pharmacy

O. V. Grechana, Zaporizhzhia State Medical University

PhD (Pharmacy), Associate Professor of the Department of Pharmacognosy, Pharmacology, and Botany

Yu. V. Pervun, Kyiv National University of Technologies and Design

Master's graduate of the Department of Industrial Pharmacy

References

Kaur D, Kaur J, Kamal SS. Diacerein, its beneficial impact on chondrocytes and notable new clinical applications. Brazilian Journal of Pharmaceutical Sciences. 2019;54(4):e17534. https://doi.org/10.1590/s2175-97902018000417534. DOI: https://doi.org/10.1590/s2175-97902018000417534

Cunbin Du, Yang Cong, Zhouyu Jiang, Meng Wang, Mingliang Wang. Dissolution behavior and preferential solvation of diacerein in mixtures of (ethyl acetate/acetonitrile + ethanol) at several temperatures. The Journal of Chemical Thermodynamics. 2021;160:106482. https://doi.org/10.1016/j.jct.2021.106482. DOI: https://doi.org/10.1016/j.jct.2021.106482

Massimo Bambagiotti-Alberti, Gianluca Bartolucci, Bruno Bruni, Silvia A. Coran, Massimo Di Vaira. Physico-chemical and structural characterization of diacerhein. Journal of Pharmaceutical and Biomedical Analysis. 2009;49(4):1065-1069 https://doi.org/10.1016/j.jpba.2009.01.018. DOI: https://doi.org/10.1016/j.jpba.2009.01.018

Saliy OO, Los OV, Baula OP, Turchyna VU. Development of composition and evaluation of equivalence of diacerein hard gelatin capsules. Farmatsevtychnyi Zhurnal. 2021;(6):62-72. https://doi.org/10.32352/0367-3057.6.21.06. DOI: https://doi.org/10.32352/0367-3057.6.21.06

De Oliveira PG, Termini L, Durigon EL. et al. Diacerein: A potential multi-target therapeutic drug for COVID-19. Medical hypotheses. 2020;144:109920. https://doi.org/10.1016/j.mehy. 2020.109920. DOI: https://doi.org/10.1016/j.mehy.2020.109920

Borgmann S, Parcianello L, Arend M, Bajerski L, Cardoso S. Development and Validation of a Dissolution Method with Spectrophotometric Analysis for Diacerhein Capsules. Scientia Pharmaceutica. 2008; 76(3):541-554. https://doi.org/10.3797/scipharm.0804-17. DOI: https://doi.org/10.3797/scipharm.0804-17

Diacerein (2409). European Pharmacopoeia. 9th Edition. – European Directorate for the Quality of Medicines (EDQM). – Council of Europe, 67075 Strasbourg Cedex, France 2016;4016.

Azza Hasan, Abd El hakim Ramadan, Mahmoud Abd Elghany, Shereen Sabry. Journal of Applied Pharmaceutical Science. 2020;10(06):044-053 https://doi.org/10.7324/JAPS.2020.10607. DOI: https://doi.org/10.7324/JAPS.2020.10607

Jain S., Nagori B.P., Yadav S.K. Improvement of the Dissolution Behavior of the Poorly Water Soluble Drug Diacerein by Solid Dispersion Technology and its Formulation into Tablet Dosage Form. Madridge Journal of Novel Drug Research. 2018;2(1):79-89. https://doi: 10.18689/mjndr-1000112. DOI: https://doi.org/10.18689/mjndr-1000112

Mukhopadhyay S, Roy T, Chatterjee TK. Formulation Development and Evaluation of Diacerein Loaded Microsphere by Spray Coating (Wurster Method), Journal of Drug Delivery and Therapeutics. 2019;9(4):454-60 http://dx.doi.org/10.22270/jddt.v9i4.3082.

Pandey R, Patil PO, Patil MU, Deshmukh PK, Bari SB. Quantitative estimation of diacerein in bulk and in capsule formulation using hydrotropic solubilizing agents by UV-spectrophotometry and the first order derivative using the area under curve method. Pharmaceutical methods. 2012; 3(1):4–8. https://doi.org/10.4103/2229-4708.97703. DOI: https://doi.org/10.4103/2229-4708.97703

Sandeepa Bhoir, Shashikant Dhole, Nilesh Kulkarni, Prajakta Sangole, Sonal Thorat, Dhanashree Bhoite. Novel and validated spectrophotometric estimation of diacerein in bulk and capsule formulation using mixed hydrotropic solubilisation approach. International Journal of Pharmacy and Pharmaceutical Sciences. 2012;4(l.4):501-4. https://innovareacademics.in/journal/ijpps/ Vol4Suppl4/4574.pdf.

Bhoir S, Dhole S, Kulkarni N, Sangole P. Novel and validated spectrophotometric estimation of diacerein in bulk and capsule formulation using mixed hydrotropic solubilization approach. International Journal of Pharmacy and Pharmaceutical Sciences. 2012;4(5):501-504.

Validation of Analytical Methods and Tests. State Pharmacopoeia of Ukraine: 1 Vol. Kharkiv: Ukrainian Scientific Pharmacopoeia Center of Quality of Medicinal Products. Ed.2. Vol.1. [Державна Фармакопея України: в 3 т./ Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2-е вид., Т.1]: Kharkiv: Ukrainian Scientific Pharmacopoeia Center of Quality of Medicinal Products; 2015;910-29. Ukrainian.

Analytical Procedures and Methods Validation for Drugs and Biologics: Guidance for Industry / FDA CDER, etc. U.S. Department of Health and Human Services, 2015;18. [Online resource] Available at: https://www.fda.gov/media/87801/download.

Statistical Analysis of Chemical Experiment Results. State Pharmacopoeia of Ukraine. Vol. 1 / State Enterprise "Scientific-Expert Pharmacopoeial Center" – 2nd edition. – Kharkiv: State Enterprise "Scientific-Expert Pharmacopoeial Center", 2015:881–909. Ukrainian

Published

2023-11-30

How to Cite

Saliy, O. O., Bessarabov, V. I., Grechana, O. V., & Pervun, Y. V. (2023). VALIDATION OF THE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF DIACEREIN IN THE "DISSOLUTION" TEST OF SOLID GELATIN CAPSULES. Pharmaceutical Review Farmacevtičnij časopis, (4), 30–39. https://doi.org/10.11603/2312-0967.2023.4.14116

Issue

Section

Analysis of drugs