Development and validation of analytical method by HPLC-DAD for determination of vasodilator active in pharmaceutical ophthalmic forms
Rev. ciênc. farm. básica apl
;
41: [9], 01/01/2020. tab, ilus
Article
in English
| LILACS
| ID: biblio-1128568
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 Æm 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.(AU)
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Ophthalmic Solutions
/
Vasodilator Agents
/
Benzamidines
/
Diminazene
Type of study:
Practice guideline
Language:
English
Journal:
Rev. ciênc. farm. básica apl
Journal subject:
Pharmacology
Year:
2020
Type:
Article
Affiliation country:
Brazil
Institution/Affiliation country:
Universidade Federal de Minas Gerais (UFMG)/BR
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