Determination of the validation characteristics of Raman spectra and of the integrated intensity of UV spectra of paracetamol containing model mixtures

UV spectroscopy is used in pharmaceutical analysis to determine the quality of pharmaceutical substances and preparations as a versatile and sensitive method that allows to analyze small quantities of drugs, including in a single dose, as well as perform the analysis automatically and in a short time. Raman spectroscopy which is not inferior in its capabilities to UV spectroscopy is characterized as an express and non-destructive method. Purpose of the study. To assess the possibility of using total spectra for the development of an express and economical method for the determination of the quality of industrial drugs of complex composition using Raman spectra and integral intensity. Material and methods. The objects of research were the substances of paracetamol Hebei Jiheng batch № 1606107, Daru Phash batch № 309547, Anqiu Luan batch № 1730144, Zhejiang Kanglite batch № 7602925; Solpadein fast soluble tablets, Solpadein fast film-coated tablets, Migrenol, Migrenium; model mixtures that reproduce the composition of the tablets under study and contain 80120% of active substances from the nominal amount. Certified and calibrated equipment was used, the validation assessment was carried out in accordance with the recommendations of Russian Pharmacopoeia (14 edition). Results. By the example of paracetamol substances from different manufacturers, the stability and reproducibility of the Raman spectra was shown, the absence of the influence of the analysis duration on the position of the characteristic signals of the Raman spectrum was established. On the model two-component mixtures and some commercially available tablets containing paracetamol the possibility of assessing the quality by means of the integral intensity of the total UV absorption spectrum was studied. Conclusions. The validation assessment showed that the Raman spectra and the integrated intensity of the total UV spectra are stable and reproducible indicators that can be used as an additional characteristic for an alternative rapid assessment of the quality of pharmaceutical substances and two-component preparations. They may be recommended as methods for the implementation of stepwise control of pharmaceutical production.

Raman spectroscopy, ultraviolet spectroscopy, integrated intensity value, total UV-spectrum, paracetamol, validation characteristics