title: A Novel High Performance Liquid Chromatographic Method for Determination of Nystatin in Pharmaceutical Formulations by Box-Behnken Statistical Experiment Design.
abstract: In this study a novel High Performance Liquid Chromatography for the assay of nystatin in oral and vaginal tablets were optimized and validated using Box-Behnken experimental design. The method was performed in the isocratic mode on a RP-18 column (30 °C) using a mobile phase consisting of ammonium acetate 0.05 M buffer/ Methanol mixture (30:70) and a flow-rate of 1.0 mL/min. The specificity, linearity, precision, accuracy, LOD and LOQ of the method were validated. The method was linear over the range of 5-500 µg/mL with an acceptable correlation coefficient (r(2) = 0.9996). The method's limit of detection (LOD) and quantification (LOQ) were 0.01 and 0.025 µg/mL respectively. The results indicate that this validated method can be used as an alternative method for assay of nystatin.
authors.affiliation: Department of Pharmaceutics, Pharmaceutical Sciences Branch, Islamic Azad University (IAU), Tehran, Ira n .
authors.forename: Farnaz
authors.initials: F
authors.lastname: Shokraneh
authors.affiliation: Department of Pharmaceutics, Pharmaceutical Sciences Branch, Islamic Azad University (IAU), Tehran, Ira n .
authors.forename: Ramin
authors.initials: R
authors.lastname: Asgharian
authors.affiliation: Department of Pharmaceutics, Pharmaceutical Sciences Branch, Islamic Azad University (IAU), Tehran, Ira n . ; Quality Assurance Lab, Jaber Ebne Hayyan Pharmaceutical Company, Tehran, Iran.
authors.forename: Assem
authors.initials: A
authors.lastname: Abdollahpour
authors.affiliation: Quality Assurance Lab, Jaber Ebne Hayyan Pharmaceutical Company, Tehran, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Ramin
authors.affiliation: Afa Chemi Pharmaceutical Company, Tehran, Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Montaseri
authors.affiliation: Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Ira n .
authors.forename: Arash
authors.initials: A
authors.lastname: Mahboubi
keywords: Box–Behnken experimental design; High performance liquid chromatography; Nystatin