Author/Authors :
Shokraneh, Farnaz Department of Pharmaceutics - Pharmaceutical Sciences Branch - Islamic Azad University (IAU), Tehran , Asgharian, Ramin Department of Pharmaceutics - Pharmaceutical Sciences Branch - Islamic Azad University (IAU), Tehran , Abdollahpour, Assem Department of Pharmaceutics - Pharmaceutical Sciences Branch - Islamic Azad University (IAU), Tehran , Ramin, Mehdi Quality Assurance Lab - Jaber Ebne Hayyan Pharmaceutical Company, Tehran , Montaseri, Ali Afa Chemi Pharmaceutical Company, Tehran , Mahboubi, Arash Department of Pharmaceutics - School of Pharmacy - Shahid Beheshti University of Medical Sciences, Tehran
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 (r2 = 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.
