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THE APPLICATION OF GAS CHROMATOGRAPHY FOR DETERMINATION OF RESIDUAL SOLVENTS IN MELATONIN

Melatonin is a hormone secreted by the pineal gland and has many various effects on the body, hence it is used as an active component in various pharmaceutical products. Even though many exogenous sources of melatonin can be found, the concentration of melatonin in them is usually low, so synthetic melatonin is used in the preparation of before mentioned pharmaceutical products. One of major problems with synthetized compounds are residual solvents, which may be dangerous to health. Therefore, the main goal of this work was to develop and validate a HSS-GC-FID method for determination of residual solvents (methanol, 2- propanol, tert-butyl methyl ether and ethyl acetate) in synthetized melatonin. Key validation parameters were selectivity, linearity, range, precision, accuracy, stability, and limits of detection and quantification. Method has been validated in accordance with ICH guidelines1, 2 and quantification and detection limit for all studied solvents was determined. Results of validation experiments confirmed this method as highly selective, linear in working range, accurate and precise. Standard and sample solutions were stable for two days at room temperature and in the fridge. Since all conditions for validation were met, it can be concluded that the developed HSS- GC-FID method for the determination of residual organic solvents in melatonin raw material is suitable for its intended purpose.

melatonin ; residual solvents ; GC

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