Разработка и регистрация лекарственных средств (Jan 2019)
DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC TECHNIQUES OF DETERMINATION OF AMINOCAPROIC ACID IN A MULTI-COMPONENT HEMOSTATIC AGENT
Abstract
The article describes a method for quantitative determination of aminocaproic acid in a multi-component hemostatic medical agent having the local effect. The analysis uses the method of direct spectrophotometry with the wavelength of 568 nm. Based on the results of the study, the main validation characteristics of the method meet the eligibility criteria according to the general pharmaceutical article «Validation of analytical methods» from the XIII edition of the State Pharmacopoeia. The analytical area of the procedure was 0.04-0.06 g/ml. The technique can be reproduced in laboratories with the confidence level P=95%, the correctness of the measurement was 1.36%.