title: UV Spectrophotometric Determination and Validation of Hydroquinone in Liposome.
abstract: The method has been developed and validated for the determination of hydroquinone in liposomal formulation. The samples were dissolved in methanol and evaluated in 293 nm. The validation parameters such as linearity, accuracy, precision, specificity, limit of detection (LOD) and limit of quantitation (LOQ) were determined. The calibration curve was linear in 1-50 µg/mL range of hydroquinone analyte with a regression coefficient of 0.9998. This study showed that the liposomal hydroquinone composed of phospholipid (7.8 %), cholesterol (1.5 %), alpha ketopherol (0.17 %) and hydroquinone (0.5 %) did not absorb wavelength of 293 nm if it diluted 500 times by methanol. The concentration of hydroquinone reached 10 µg/mL after 500 times of dilution. Furthermore, various validation parameters as per ICH Q2B guideline were tested and found accordingly. The recovery percentages of liposomal hydroquinone were found 102 ± 0.8, 99 ± 0.2 and 98 ± 0.4 for 80%, 100% and 120% respectively. The relative standard deviation values of inter and intra-day precisions were <%2. LOD and LOQ were 0.24 and 0.72 µg/mL respectively.
authors.affiliation: Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.
authors.forename: Rabea
authors.initials: R
authors.lastname: Khoshneviszadeh
authors.affiliation: Biotechnology Research Center, Drug and Food Control Department, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Bibi Sedigheh
authors.initials: BS
authors.lastname: Fazly Bazzaz
authors.affiliation: Chemistry Department, Faculty of Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.
authors.forename: Mohammad Reza
authors.initials: MR
authors.lastname: Housaindokht
authors.affiliation: Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran. ; Biosensor Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Azadeh
authors.initials: A
authors.lastname: Ebrahim-Habibi
authors.affiliation: Drug and Food Control Department, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Omid
authors.initials: O
authors.lastname: Rajabi
keywords: Hydroquinone; Liposome; UV spectroscopy; Validation