VALIDATION OF THE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF DIACEREIN IN THE "DISSOLUTION" TEST OF SOLID GELATIN CAPSULES
DOI:
https://doi.org/10.11603/2312-0967.2023.4.14116Keywords:
diacerein, dissolution test, spectrophotometry, quantitative determination, validation characteristics, diacerein, Dissolution test, spectrophotometry, quantitative determination, validation characteristics, linearity., precision, repeatability, specificityAbstract
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.
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