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

The aim of the work was to develop and validate a spectrophotometric method for the determination of rosuvastatin in tablets based on the reaction with BPB.

Material and methods. Analytical equipment: two-beam UV-visible spectrophotometer Shimadzu model -UV 1800 (Japan), software UV-Probe 2.62, laboratory electronic balance RAD WAG AS 200/C. The following APIs, dosage forms, reagents and solvents were used in the work: pharmacopoeial standard sample (CRS) of rosuvastatin calcium (Sigma-Aldrich, (≥ 98%, HPLC)), BPB (Sigma-Aldrich, (≥ 98%, HPLC)), "Rosuvastatin" tablets 10 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 the determination of rosuvastatin by reaction with BPB in a 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 in accordance with the requirements of the SPhU. The analytical method was linear in the concentration range of 7.99-23.97 μmol/L. According to the «greenness» pictogram of the analytical method using the AGREE method, the score was 0.79 and indicates that the proposed spectrophotometric method for the determination of rosuvastatin was developed in compliance with the principles of «green» chemistry.

Conclusions. The proposed spectrophotometric method has a low negative impact on the environment and can be applied for the purposes of routine pharmaceutical analysis.