Analysis of sodium chloride in a multicomponent hemostatic formulation

Introduction. Preclinical trials have shown that the designed hemostatic formulation is an effective remedy for local bleeding in neurosurgical practice. The pharmacological effect of the formulation is due to an antifibrinolytic component (aminocaproic acid and iron salt) that causes coagulation, and an isotonic component (sodium chloride). Objective: to develop and validate a procedure for quantification of the isotonic component (sodium chloride) of a hemostatic agent. The argentometric titration method was chosen for developing the procedure. Material and methods. The composition of the topical hemostatic formulation as a solution (aminocaproic acid, iron (III) chloride hexahydrate, sodium chloride, and purified water) was used as the investigation object. The titrimetric analysis method was applied. The data were processed with statistical data analysis methods in accordance with General Pharmacopoeia Article 1.1.0013.15 «Statistical processing of experimental results» in the 14th edition of the Russian Federation’s State Pharmacopoeia, by using the Microsoft Excel program. Results. The content of sodium chloride was measured in the hemostatic formulation. The suitability of the techniques was assessed applying the validation procedure with the following indicators: linearity, analytical domain, correctness, and reproducibility. The range of the analytical procedure was 0.001 to 0.5 g. The procedure can be reproduced in the laboratory setting with a confidence probability of P=95% and Xmean±ΔX=0.10375±0.00011 g. Conclusion. A procedure has been proposed to measure sodium chloride in the hemostatic formulation composition. Validation characteristics have been determined and their compliance with the necessary acceptance criteria has been experimentally confirmed