Development of the spectrophotometric method for the determination of metoprolol tartrate in tablets by using bromocresol green

Q3 Pharmacology, Toxicology and Pharmaceutics

ScienceRise: Pharmaceutical Science Pub Date : 2022-10-31 DOI:10.15587/2519-4852.2022.266068

M. Horyn, T. Kucher, Liubomyr Kryskiw, O. Poliak, N. Zarivna, K. Peleshok, L. Logoyda

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引用次数: 3

Abstract

The aim of the work was to develop and validate a spectrophotometric method for determining metoprolol tartrate in tablets based on the reaction with bromocresol green (BCG). 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, pH-meter И-160МИ. The following APIs, dosage forms, reagents and solvents were used in the work: pharmacopoeial standard sample (CRS) of metoprolol tartrate (Sigma-Aldrich, (≥ 98 %, HPLC)), BCG (Sigma-Aldrich, (≥ 98 %, HPLC)), "Metoprolol" tablets 50 mg (Kyivmedpreparat, series 0035415), "Metoprolol" 100 mg (Farmak, series 30421), 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 was developed for determining metoprolol tartrate by reaction with BCG in a methanol solution using the absorption maximum at a wavelength of 624 nm. Stoichiometric ratios of reactive components were established, which were 1:1. The developed method for the quantitative determination of metoprolol tartrate was validated following the requirements of the SPhU. The analytical method was linear in the concentration range of 5.47-38.30 μg/mL. The limit of detection and quantification were 0.41 μg/mL and 1.24 μg/mL, respectively. According to the «greenness» pictogram of the analytical method using the AGREE method, the score was 0.79, which indicates that the proposed spectrophotometric method for the determination of metoprolol was developed in compliance with the principles of «green» chemistry.Conclusions. A spectrophotometric method for determining metoprolol tartrate in tablets based on the reaction with BCG in compliance with the principles of «green» chemistry has been developed and validated. Furthermore, the developed method for the quantitative determination of metoprolol tartrate was validated following the requirements of the SPhU. In summary, the developed method has a low negative impact on the environment and can be applied for routine pharmaceutical analysis

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溴甲酚绿分光光度法测定酒石酸美托洛尔片剂的含量

建立了一种基于溴甲酚绿(BCG)反应测定酒石酸美托洛尔片剂中酒石酸美托洛尔含量的分光光度法。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，实验室电子天平RAD WAG AS 200/C, ph计И-160МИ。本研究使用的原料药、剂型、试剂和溶剂如下:药典标准品(CRS)为酒石酸美托洛尔(Sigma-Aldrich，(≥98%，HPLC))、BCG (Sigma-Aldrich，(≥98%，HPLC))、“美托洛尔”片剂50 mg (Kyivmedpreparat，系列0035415)、“美托洛尔”100 mg (Farmak，系列30421)、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。建立了在甲醇溶液中与卡介苗反应测定酒石酸美托洛尔的分光光度法，其最大吸收波长为624 nm。确定了反应组分的化学计量比为1:1。建立了酒石酸美托洛尔的定量测定方法，并按照SPhU的要求进行了验证。该方法在5.47 ~ 38.30 μg/mL浓度范围内线性良好。检测限为0.41 μg/mL，定量限为1.24 μg/mL。根据采用AGREE方法的分析方法的“绿色度”象形图，得分为0.79，表明所建立的分光光度法测定美托洛尔的方法符合“绿色”化学的原则。建立了一种基于卡介苗反应的分光光度法测定片剂中酒石酸美托洛尔的方法，该方法符合“绿色”化学原理。建立了酒石酸美托洛尔的定量测定方法，并按照SPhU的要求进行了验证。综上所述，该方法对环境的负面影响小，可用于常规药物分析

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