We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Development and validation of analytical method by HPLC-DAD for determination of vasodilator active in pharmaceutical ophthalmic forms.
- Authors
Alves Cesar, Aina Liz; Caldeira Navarro, Larissa; de Matos Silva, Alaíde; Oliveira Castilho, Rachel; Castro Goulart, Gisele Assis; Foureaux Heida, Giselle; José Ferreira, Anderson; Cronemberger, Sebastião; Gomes Faraco, André Augusto
- Abstract
The substance 4-Aminobenzamidine dihydrochloride (4-AD) is one of the degradation products of diminazene aceturate and has demonstrated antiglaucomatous potential. Glaucoma is the second leading cause of blindness worldwide; thus, new therapeutic alternatives must be studied, for example, the molecule 4-AD vehiculated into polymeric inserts for prolonged release. The present work aims to develop and validate an analytical method to quantify 4-AD in pharmaceutical ophthalmic forms. A HPLC was used with UV-Vis detector, at 290 m and ACE® C18 column (125 × 4.6 mm, 5 µm), in which the mobile phase consists of phosphate buffer (pH 7.4) and triethylamine (30 mmol/L), under an isocratic flow of 1.0 mL/min. The retention time of 3.2 minutes was observed. The method was developed and validated in accordance with ANVISA recommendations and ICH guides. The linearity range was established between the concentrations 5 and 25 µg/mL (correlation coefficient r = 0.993). The accuracy, repeatability, and intermediate precision tests obtained a relative standard deviation less than or equal to 5%. In addition, the method was considered selective, exact. and robust, with pH being its critical factor. Therefore, the HPLC analysis method is robust and can be used to quantify 4-AD in pharmaceutical forms for ocular application.
- Subjects
HIGH performance liquid chromatography; RF values (Chromatography); STANDARD deviations; STATISTICAL correlation; TRIETHYLAMINE
- Publication
Revista de Ciências Farmacêuticas Básica e Aplicada, 2020, Vol 41, p1
- ISSN
1808-4532
- Publication type
Article
- DOI
10.4322/2179-443X.0636