Validation of the spectrophotometric method of determination of drug substance in medicine “Chloropyraminum, cream”

Abstract

The article is devoted to validation of method of quantitative determination of drug substance – chloropyramine in medicine “Chloropiraminum, cream for external application, 10 mg/g”. The research purpose was to conf irm documentarily that a spectrophotometric method is suitable for quantitative determination of chloropyramine hydrochloride in medicine “Chloropyraminum, cream for external application, 10 mg/g” and allows getting results with the required metrology characteristics. The research objects were the samples of medicine “Chloropyraminum, cream fo r external application, 10 mg/g”. The absorbance measurements were conducted at the spectrophotometer of RV 2201A. It was developed the plan of validation, including the determination of the following validation characteristics: selectivity, trueness, application range, linearity and precision (repeatability and repro-ducibility within the laboratory). For every validation characteristic the criteria of acceptability were calculated. In accordance with the developed plan the experimental researches were carried out and it was found out that validation characteristics were in the accordance with th e criteria of acceptability. As a result of validation which was carried out in accordance with TKP 030-2013 (02040) it was con-firmed that spectrophotometric method for determination of chloropyramine hydrochloride in medicine “Chloropyraminum, cream for external application, 10 mg/g” is available.