Partial validation of the chromato-mass-spectrometric methodology for the determination of carbon sulfur in infusion medicines

Relevance. Nowadays the standardization and control of medicines to provide the consumer with high-quality pharmaceutical products is an important issue. The use of parenteral medicines is associated with the potential risk of exposure to the patient's body of carbon disulfide, which is contained in rubber plugs and can pose a serious health hazard.

The purpose of this article is to conduct partial validation of the developed methodology for quantification of carbon disulfide impurities in infusion dosage forms by chromato-mass spectrometry.

Material and methods. The model solution was the drug "Reopoliglyukin, solution for infusion" (JSC BIOCHEMIK, Russia). Methyl ethyl sulfide, 99% (NevaReaktiv, Russia) was used as an internal standard. The measurements were carried out on a chromatography-mass spectrometer model GCMS-QP2010 Ultra, manufactured by Shimadzu, Japan.

Results. The process of sample preparation is described, also the acceptance criteria for determining specificity, linearity, accuracy and limit of quantification were set. The chromatograms and results obtained for the model sample "Rheopolyglucin, solution for infusion" are presented, the coincidence of the peak areas in terms of retention times for the model sample and carbon disulfide, as well as the internal standard, allows us to state that the method meets the requirements for the "Specificity" indicator. The necessary calculations were made to confirm that the analytical methodology is linear. The limit of quantitation was found experimentally by means of a series of dilutions. The correctness was confirmed using the method of additions.

Conclusion. The measures taken made it possible to carry out a partial validation of the analytical methodology for determining carbon disulfide impurities in infusion drugs. It has been determined that all the results obtained meet the indicated acceptance criteria within the selected range of characteristics. Also, it was confirmed that in the indicated concentrations, the methodology has no system error.