Full green assay of rosuvastatin utilizing sulphophtalein dyes: application to tablet analysis

Authors

DOI:

https://doi.org/10.15587/2519-4852.2024.310564

Keywords:

Rosuvastatin, Spectrophotometry, Sulphophtalein dyes, Bromocresol green, Bromocresol purple, Bromothymol blue, Tablet, Validation

Abstract

The aim of the work was to develop a «green» and extraction-free spectrophotometric procedure for the assay of rosuvastatin in tablets. The present work describes three new spectrophotometric procedures (A, B and C) that can be utilized for routine quality control of rosuvastatin in laboratories.

Materials and methods. Analytical instrumentation: Shimadzu UV-1800 double beam UV-vis spectrophotometer (Japan) with attached UV-Probe ver. 2.62 software, RAD WAG AS 200/C precise analytical balance (Poland). Rosuvastatin calcium (purity ≥98 % (HPLC)) was bought from Sigma-Aldrich Chemicals Co. (St. Louis, MO, USA). Rosuvastatin 10 mg tablets were acquired from a nearby drugstore. All solvents used in this study, including methanol, ethanol, chloroform, acetonitrile and ethyl acetate, were produced by Honeywell and had a purity of 99.9 %. BCG, BCP and BTB were acquired from Sigma-Aldrich Chemicals Co. (USA, St. Louis). All chemicals utilized in the experiment were of analytical purity.

Results and discussion. New simple «green» and extraction-free spectrophotometric procedures for assay of rosuvastatin in tablets involve the formation of ion-pair complexes with sulphophtalein dyes (BCG (Method A), BCP (Method B), BTB (Method C)) have been developed. The absorbances of the coloured reaction products were registered at 405 nm (Method A) and 400 nm (Methods B, C). The concentration was linearly proportional to absorbance values in the range of 2.51-20.08 μg/mL (method A), 2.50-24.90 μg/mL (method B) and 2.51-12.56 μg/mL (method C). Estimation of LOD and LOQ parameters were obtained as 0.67 μg/mL and 2.23 μg/mL (Method A), 0.39 μg/mL and 1.32 μg/mL (Method B), 0.30 μg/mL and 1.01 μg/mL (Method C). The stoichiometric ratio of the reactive components of rosuvastatin - BCG, BCP, and BTB corresponded 1: 1. The %RSD values of intra-day and inter-day were obtained less than < 1.5 %, which showed excellent repeatability and RE % data was ≤ 3 %. The effect on the environment of the proposed spectrophotometric procedures and their compliance with the GAC principles were endorsed by the output of AGREE, GAPI, and AES metrics tools. The values of these three «green» metrics show that the proposed spectrophotometric procedures had a low environmental impact compared with the reported ones.

Conclusions. The developed fast, simple and cost-effective methods A, B, and C can be used for routine analysis of rosuvastatin in tablets

Author Biographies

Liudmyla Halka, I. Horbachevsky Ternopil National Medical University

PhD 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 Piponski, Replek Farm Ltd. Company for Pharmaceutical-Chemical Products

PhD, Head of Department

Instrumental Analysis, Quality Control Department

Mariana Horyn, I. Horbachevsky Ternopil National Medical University

PhD, Assistant

Department of Pharmaceutical Chemistry

Olha Poliak, I. Horbachevsky Ternopil National Medical University

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Nadiya Zarivna, 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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Full green assay of rosuvastatin utilizing sulphophtalein dyes: application to tablet analysis

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Published

2024-08-30

How to Cite

Halka, L., Kucher, T., Kryskiw, L., Piponski, M., Horyn, M., Poliak, O., Zarivna, N., & Logoyda, L. (2024). Full green assay of rosuvastatin utilizing sulphophtalein dyes: application to tablet analysis. ScienceRise: Pharmaceutical Science, (4 (50), 4–13. https://doi.org/10.15587/2519-4852.2024.310564

Issue

No. 4 (50) (2024)

Section

Pharmaceutical Science

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Copyright (c) 2024 Liudmyla Halka, Tetyana Kucher, Liubomyr Kryskiw, Marjan Piponski, Mariana Horyn, Olha Poliak, Nadiya Zarivna, Liliya Logoyda

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