VALIDATION OF THE METHOD OF QUANTITATIVE DETERMINATION OF ALKILDIMETHYLBENZYLAMMONIUM CHLORIDE BY THE METHOD OF DIRECT ABSORPTION SPECTROPHOTOMETRY IN THE DISINFECTANT "VIROSAN F"
DOI:
https://doi.org/10.11603/2312-0967.2021.1.11982Keywords:
alkylbenzyldimethylammonium chloride, active pharmaceutical ingredient, quaternary ammonium compounds, disinfectants, spectrophotometry, validationAbstract
The aim of the work. Development and validation of a method for quantitative determination of alkylbenzyldimethylammonium chloride with satisfactory metrological characteristics in the combined disinfectant "Virosan F" by direct UV-spectrophotometry.
Materials and Methods. Disinfectant "Virosan F (LLC "BioTestLaboratory", Kyiv, Ukraine), which contains alkylbenzyldimethylammonium chloride (50 mg · mL– 1), glutaraldehyde and formaldehyde as active substances, as well as excipients was syntanol and purified water. In the work was used a secondary pharmacopoeial standard sample of alkylbenzyldimethylammonium chloride and excipients of pharmacopoeial purity (Sigma-Aldrich). Spectrophotometric measurements were performed on a scanning spectrophotometer Cary 50 Scan WinUV-Visible Spectrophotometer (Varian), in quartz cells with 10 mm path length.
Results and Discussion. The method of direct spectrophotometric determination of alkylbenzyldimethylammonium chloride in combination with two aldehydes (glutaral dialdehyde and formaldehyde) in aqueous solutions of one of the fairly common disinfectants "Virosan F" was developed and validated. The calculated values of the total predicted uncertainty do not exceed the maximum allowable systematic error of the results of the analysis of disinfectant "Virosan F". The placebo solution spectrum completely lacks all the light absorption maxima characteristic of alkylbenzyldimethylammonium chloride. The ratio of the absorption of the placebo solution to the absorption of the compensation solution is insignificant compared to the maximum allowable systematic error of the analysis results. The dependence of the change in the values of the absorption of the model and test solutions of the disinfectant "Virosan F" on the storage time is insignificant compared to the maximum allowable systematic error of the analysis results. The determined parameters of linearity of the linear dependence of the analytical signal on the concentration of alkylbenzyldimethylammonium chloride in the model diluted solutions of disinfectant "Virosan F" meet the criteria of linearity, precision and accuracy. The value of Δintra, calculated when checking the intra-laboratory precision does not exceed the maximum allowable uncertainty of the analysis results. Compliance of all validation indicators with pharmacopoeial criteria is a reason to claim that the developed method is suitable for determining the content of alkylbenzyldimethylammonium chloride in the studied disinfectant.
Conclusions. A new analytical method for the quantitative determination of alkylbenzyldimethylammonium chloride in a combined disinfectant by direct absorption spectrophotometry in the ultraviolet region was proposed. The results of validation studies using acceptability criteria for tolerances of content deviation from the nominal value of B = ± 10%, confirm the specificity, robustness, linearity, correctness, precision and intra-laboratory precision of the proposed method in the range of its application.
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