title: Validated spectrophotometric and spectrofluorimetric methods for determination of chloroaluminum phthalocyanine in nanocarriers.
abstract: UV-VIS-Spectrophotometric and spectrofluorimetric methods have been developed and validated allowing the quantification of chloroaluminum phthalocyanine (CIAIPc) in nanocarriers. In order to validate the methods, the linearity, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy, and selectivity were examined according to USP 30 and ICH guidelines. Linearities range were found between 0.50-3.00 microg x mL(-1) (Y = 0.3829 X [CIAIPc, microg x mL(-1)] + 0.0126; r = 0.9992) for spectrophotometry, and 0.05-1.00 microg x mL(-1) (Y = 2.24 x 10(6) X [CIAIPc, microg x mL(-1)] + 9.74 x 10(4); r = 0.9978) for spectrofluorimetry. In addition, ANOVA and Lack-of-fit tests demonstrated that the regression equations were statistically significant (p<0.05), and the resulting linear model is fully adequate for both analytical methods. The LOD values were 0.09 and 0.01 microg x mL(-1), while the LOQ were 0.27 and 0.04 microg x mL(-1) for spectrophotometric and spectrofluorimetric methods, respectively. Repeatability and intermediate precision for proposed methods showed relative standard deviation (RSD) between 0.58% to 4.80%. The percent recovery ranged from 98.9% to 102.7% for spectrophotometric analyses and from 94.2% to 101.2% for spectrofluorimetry. No interferences from common excipients were detected and both methods were considered specific. Therefore, the methods are accurate, precise, specific, and reproducible and hence can be applied for quantification of CIAIPc in nanoemulsions (NE) and nanocapsules (NC).
authors.affiliation: Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Ciências Farmacêuticas de Ribeirão Preto (FCFRP), Universidade de São Paulo, Ribeirão Preto-SP, Brasil.
authors.forename: M P
authors.initials: MP
authors.lastname: Siqueira-Moura
authors.forename: F L
authors.initials: FL
authors.lastname: Primo
authors.forename: A P F
authors.initials: AP
authors.lastname: Peti
authors.forename: A C
authors.initials: AC
authors.lastname: Tedesco
mesh_terms: D000465:Algorithms; D000704:Analysis of Variance; D002851:Chromatography, High Pressure Liquid; D004337:Drug Carriers / Q000032:analysis*; D007202:Indicators and Reagents; D007211:Indoles / Q000032:analysis*; D053758:Nanoparticles / Q000032:analysis*; D009942:Organometallic Compounds / Q000032:analysis*; D011838:Radiation-Sensitizing Agents / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D012995:Solubility; D013050:Spectrometry, Fluorescence; D013056:Spectrophotometry, Ultraviolet
chemical_list: D004337:Drug Carriers; D007202:Indicators and Reagents; D007211:Indoles; D009942:Organometallic Compounds; D011838:Radiation-Sensitizing Agents; C044797:chloroaluminum phthalocyanine