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

Proceedings of MOL2NET'22, Conference on Molecular, Biomedical & Computational Sciences and Engineering, 8th ed. - MOL2NET: FROM MOLECULES TO NETWORKS Pub Date : 2022-12-25 DOI:10.3390/mol2net-08-13905

Liudmyla Halka, T. Kucher, Liubomyr Kryskiw, Marjan Piponsk, Iryna Furdela, T. Uglyar, O. Poliak, L. Logoyda

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引用次数: 1

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

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溴酚蓝分光光度法测定瑞舒伐他汀片中的含量

本工作的目的是建立一种符合“绿色”化学原则的基于与BPB反应的分光光度法测定片剂中瑞舒伐他汀的方法。材料和方法。分析设备:双光束紫外可见分光光度计岛津型号-UV 1800(日本)，软件UV-Probe 2.62，电子实验室天平RAD WAG AS 200/C。工作中使用的原料药、剂型、试剂和溶剂为:药典标准品(CRS):瑞舒伐他汀钙(Sigma-Aldrich，(≥98%，HPLC))、BCG (Sigma-Aldrich，(≥98%，HPLC))、瑞舒伐他汀片10 mg、15 mg、20 mg、甲醇(霍尼韦尔，(≥99.9%，GC))、乙醇(霍尼韦尔，(≥99.9%，GC))、氯甲烷(霍尼韦尔，(≥99.9%，GC))、乙腈(霍尼韦尔，(≥99.9%，GC))、乙酸乙酯(霍尼韦尔，(≥99.7%，GC))。结果和讨论。建立了在乙腈溶液中与BPB反应测定瑞舒伐他汀的分光光度法，最大吸收波长为595 nm。确定了反应组分的化学计量比为1:1。建立了瑞舒伐他汀的定量测定方法，并按照SPhU的要求进行了验证。该方法在7.99 ~ 23.97 μmol/L浓度范围内线性良好。LOD和LOQ分别为0.77µmol/L和2.36µmol/L。根据AGREE方法分析方法的“绿色度”象形图，得分为0.77，表明所提出的瑞舒伐他汀分光光度法测定方法符合“绿色”化学原则。结论。建立了一种基于与BPB反应的环保分光光度法定量测定瑞舒伐他汀片剂中的含量。选择了适宜的磺胺吡啶染料(BPB)及其浓度(4.00 × 10-4)、适宜的环保溶剂(乙腈)和适宜的波长(595 nm)，并计算了反应的灵敏度。验证了该分析方法的有效性，表明了其在药物分析中的应用可能性

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Proceedings of MOL2NET'22, Conference on Molecular, Biomedical & Computational Sciences and Engineering, 8th ed. - MOL2NET: FROM MOLECULES TO NETWORKS

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