Development of the spectrophotometric method for the determination of meldonium in capsules by using alizarine

Abstract

The aim of the work was to develop a simple, rapid, economic spectrophotometric method for the determination of meldonium in capsules based on the reaction with alizarin. Materials and methods. Analytical equipment: double-beam UV-visible spectrophotometer Shimadzu UV 1800 (Japan), a pair of 1 cm matched quartz cells, software UV-Probe 2.62, laboratory electronic balance RAD WAG AS 200/C, pH-meter И-160МИ. Pharmacopoeial standard sample (CRS) of meldonium dihydrate (Sigma-Aldrich, (≥ 98 %, HPLC)), alizarin (Synbias), capsules Metamax (Darnytsia) 250 mg, Vasopro (Farmak) 500 mg, Mildronate (Grindex) 500 mg, dimethylformamide (“Honeywell Riedel-de Haen”). Results and discussion. A spectrophotometric method for determining meldonium in capsules by reaction with alizarine has been developed. The absorption maximum of the formed complex in dimethylformamide was at a wavelength of 517 nm. Stoichiometric ratios of reactive components «meldonium- alizarin» were 1:1. Validation of the developed analytical method for the determination of meldonium in medicines was carried out in accordance with the requirements of the SPhU. The optimal conditions for performing the quantitative determination of meldonium have been established: concentration of alizarin solution – 0.8 %, volume 0.8 % alizarin solution – 0.5 ml, heating time – 20 min, temperature – 95+/- 2 °C. Linearity has been in the concentration range of 0.0402- 0.1073 mg/mL, the limit of detection - 2.84 μg/mL, and the limit of quantification – 8.59 μg/mL. The eco-friendliness of the developed analytical method was carried out using the analytical eco-scale, AGREE, and GAPI methods. Conclusions. The developed method can be used as an arbitration method for the routine analysis of meldonium capsules