SPECTROPHOTOMETRIC DETERMINATION OF METFORMIN HYDROCHLORIDE IN TABLETS BY REACTION WITH BROMCRESOL GREEN
DOI:
https://doi.org/10.11603/2312-0967.2023.2.14046Keywords:
metformin hydrochloride, spectrophotometry, sulfophthalein dyes, validation., quantitative determination, State Pharmacopoeia of UkraineAbstract
The aim of the work. Development and validation of a spectrophotometric method for the quantitative determination of metformin hydrochloride in tablets by reaction with sulfophthalein dyes
Materials and methods. The following were used for the analysis:
- metformin hydrochloride substance of pharmacopoeial purity.
- tablets – "Metformin Astrapharm" 500 mg, "Metformin Teva" 1000 mg, "Metformin Sandoz" 850 mg, "Metformin Glucophage" 500 mg.
- reagents - sulfophthalein dyes: bromocresol green (Synex Pharma, China), bromocresol purple (Shostkin Chemical Reagent Plant, Ukraine), bromothymol blue (Synex Pharma, China), thymol blue (Shostkin Chemical Reagent Plant, Ukraine). All reagents of analytical grade.
- solvent – acetone of analytical grade and purified water.
- analytical equipment – spectrophotometer "Specord-200" (Analytic Jena AG, Germany), electronic laboratory scales RADWAG XA 210. 4Y, measuring laboratory vessels of class A.
Results and Discussion. A new, simple spectrophotometric method was developed for the quantitative determination of metformin hydrochloride in tablets by reaction with bromocresol green (BCG) in 1 % water-acetone medium. The maximum absorption is at 408 nm. Compliance with the basic law of light absorption is within concentrations of 0.5–1.2 mg/100 ml. The detection limit value is 0,433∙10-6 g/ml, which indicates a high sensitivity of the reaction. In accordance with the requirements of the State Pharmacopoeia of Ukraine (SPU), some validation characteristics were determined for the developed methodology, namely, linearity, accuracy, correctness and robustness. The "greenness" of the method was also checked using the AGREE tool (Analytical GREEnness) and an analytical eco-scale.
Conclusions. As a result of the study, a spectrophotometric method for the quantitative determination of metformin hydrochloride was developed and validated. This technique is simple, accessible and meets the requirements of SPU, so it can be recommended for use in laboratories for quality control of medicines.
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