The use of a hypromellose based sorbent for a solid-phase extraction in the quantitative determination of procaine in combination drugs

Aim – to assess the selectivity and metrological characteristics of the spectrophotometric method for procaine determination in combination drugs using a solid-phase extraction sorbent based on hypromellose.

Material and methods. The solid-phase extraction sorbent was obtained with hypromellose and ethyl cyanoacrylate; the procaine hydrochloride and sodium hydroxide formed the active centers. The sorbent was prepared using a standard method. The sorption capacity of the obtained sorbent samples for procaine was 10.2 ± 1.0 µg/g. For the study, we selected the combination drugs containing procaine and its salts, such as "Menovazin", "Sulfocamphocaine", and "Otolorin". The eluate optical density was registered using a SF-56 spectrophotometer (OKB SPECTR LLC) at an analytical wavelength of 292 nm in a cuvette with an optical layer thickness of 1 cm. The reference solution was a 0.1 M hydrochloric acid solution. To calculate the procaine content in the eluates, a calibration graph (dependence of eluate optical density on procaine concentration) was plotted in the concentration range of 1–20 mcg/ml. To evaluate the selectivity (specificity) of sample preparation in chromatographic separation of the combination drugs, the absorption spectra were registered in the wavelength range of 200–400 nm for eluates obtained using purified water and a 0.1 M hydrochloric acid solution. The procaine and benzocaine were identified in the eluate by the presence of absorption maxima at wavelengths of 222 and 286 nm for benzocaine, and 228 and 292 nm for procaine. For statistical processing of the experimental results and determination of metrological characteristics of the analysis method, we followed the GPM.1.1.0013 "Statistical processing of results of physical, physicochemical, and chemical tests".

Results. We have demonstrated the selectivity of the spectrophotometric determination of procaine in certain combination drugs using a solid-phase extraction sorbent based on hypromellose. The selective binding of the analyzed substance with active centers in the sorbent and stepwise elution with purified water and a 0.1 M hydrochloric acid solution during solid-phase extraction eliminated the interfering effect of drug components during the UV-spectrophotometry of procaine. The use of a hypromellose based sorbent improved the metrological characteristics and reduced the systematic error of the quantitative determination method by an average of 14.4%. The proposed methodological approach using a selective sorbent might be recommended as the quality control for combination drugs containing procaine and its salts.