Development of the spectrophotometric method for the determination of rosuvastatin in tablets by using bromophenol blue

Authors

DOI:

https://doi.org/10.15587/2519-4852.2023.277461

Keywords:

bromophenol blue, rosuvastatin, spectrophotometry, validation, quantitative determination, tablets

Abstract

The aim of the work was to develop a spectrophotometric method for the determination of rosuvastatin in tablets based on the reaction with BPB in compliance with the principles of «green» chemistry.

Material and methods. Analytical equipment: two-beam UV-visible spectrophotometer Shimadzu model -UV 1800 (Japan), software UV-Probe 2.62, electronic laboratory balance RAD WAG AS 200/C. The following APIs, dosage forms, reagents and solvents were used in work: pharmacopoeial standard sample (CRS) of rosuvastatin calcium (Sigma-Aldrich, (≥ 98 %, HPLC)), BCG (Sigma-Aldrich, (≥ 98 %, HPLC)), "Rosuvastatin" tablets 10 mg, 15 mg, 20 mg, methanol (Honeywell, (≥ 99.9 %, GC)), ethanol (Honeywell, (≥ 99.9 %, GC)), chloroform (Honeywell, (≥ 99.9 %, GC)), acetonitrile (Honeywell, (≥ 99.9 %, GC)), and ethyl acetate (Honeywell, (≥ 99.7 %, GC)).

Results and discussion. A spectrophotometric method for determining rosuvastatin by reaction with BPB in an acetonitrile solution using the absorption maximum at a wavelength of 595 nm has been developed. Stoichiometric ratios of reactive components were established, which were 1:1. The developed method for the quantitative determination of rosuvastatin was validated following the requirements of the SPhU. The analytical method was linear in the 7.99-23.97 μmol/L concentration range. The LOD and LOQ values were calculated to be 0.77 µmol/L and 2.36 µmol/L. According to the «greenness» pictogram of the analytical method using the AGREE method, the score was 0.77, indicating that the proposed spectrophotometric method for determining rosuvastatin was developed in compliance with the principles of «green» chemistry.

Conclusions. An eco-friendly spectrophotometric method has been developed to quantitatively determine rosuvastatin in tablets based on the reaction with BPB. The appropriate sulfophthalein dye (BPB) and its concentration (4.00 x 10-4), the optimal eco-friendly solvent (acetonitrile), and the appropriate wavelength (595 nm) were chosen, and the sensitivity of the reaction was calculated. The analytical method was validated, and its possibility for use in the pharmaceutical analysis was shown

Author Biographies

Liudmyla Halka, I. Horbachevsky Ternopil National Medical University

Postgraduate Student

Department of Pharmaceutical Chemistry

Tetyana Kucher, I. Horbachevsky Ternopil National Medical University

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Liubomyr Kryskiw, I. Horbachevsky Ternopil National Medical University

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Marjan Piponsk, Replek Farm Ltd. Company for pharmaceutical-chemical products

PhD, Head of Department

Instrumental analysis, Quality Control Department

Iryna Furdela, I. Horbachevsky Ternopil National Medical University

Department of Pharmaceutical Chemistry

Tetyana Uglyar, I. Horbachevsky Ternopil National Medical University

PhD, Associate Professor

Department of Oncology, Radiodiagnosis, Radiotherapy and Radiation Medicin

Olha Poliak, I. Horbachevsky Ternopil National Medical University

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Liliya Logoyda, I. Horbachevsky Ternopil National Medical University

Doctor of Pharmaceutical Sciences, Professor, Head of Department

Department of Pharmaceutical Chemistry

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Development of the spectrophotometric method for the determination of rosuvastatin in tablets by using bromophenol blue

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Published

2023-04-30

How to Cite

Halka, L., Kucher, T., Kryskiw, L., Piponsk, M., Furdela, I., Uglyar, T., Poliak, O., & Logoyda, L. (2023). Development of the spectrophotometric method for the determination of rosuvastatin in tablets by using bromophenol blue. ScienceRise: Pharmaceutical Science, (2(42), 11–19. https://doi.org/10.15587/2519-4852.2023.277461

Issue

No. 2(42) (2023)

Section

Pharmaceutical Science

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Copyright (c) 2023 Liudmyla Halka, Tetyana Kucher, Liubomyr Kryskiw, Marjan Piponsk, Iryna Furdela, Tetyana Uglyar, Olha Poliak, Liliya Logoyda

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