Validation of a UV-spectrophotometric analytical method for determination of LPSF/AC04 from inclusion complex and liposomes

Autor: Rafaela Siqueira Ferraz, Elisângela Afonso Moura Mendonça, Jéssica Priscila Avelino Silva, Isabella Macário Ferro Cavalcanti, Mariane Cajubá Britto Lira-Nogueira, Suely Lins Galdino, Ivan Rocha Pitta, Maria do Carmo Alves Lima, Nereide Stela Santos-Magalhães
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Zdroj: Brazilian Journal of Pharmaceutical Sciences, Vol 51, Iss 1, Pp 183-191 (2015)
Druh dokumentu: article
ISSN: 2175-9790
1984-8250
DOI: 10.1590/S1984-82502015000100018
Popis: The aim of this study was to develop and validate a UV spectrophotometric method for determination of LPSF/AC04 from inclusion complex and encapsulated into liposomes. The validation parameters were determined according to the International Conference on Harmonisation (ICH) and National Health Surveillance Agency (ANVISA) guidelines. LPSF/AC04 was determined at 250 nm in methanol by a UV spectrophotometric method, exhibiting linearity in the range from 0.3 to 2 µg.mL−1 (Absorbance=0.18068 x [LPSF/AC04 µg.mL-1] + 0.00348), (r2=0.9995). The limits of detection and quantification were 0.047µg.mL−1 and 0.143µg.mL−1, respectively. The method was accurate, precise, reproducible and robust since all the samples analyzed had coefficient of variation of less than 5% and no statistically significant difference between theoretical and practical concentrations was detected. Thus, a rapid, simple, low cost and sensitive spectrophotometric method was developed and validated for determining the content of inclusion complex and liposomes containing LPSF/AC04.
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