A Novel High Performance Liquid Chromatographic Method for Determination of Nystatin in Pharmaceutical Formulations by Box- Behnken Statistical Experiment Design

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 0.05 M ammonium acetate buffer/ Methanol mixture (30:70) and a flow-rate of 1.0 ml/min. The method was validated by specificity, linearity, precision, accuracy, LOD and LOQ. The method was linear over the range of 5–500 µg/ml with a good correlation coefficient (r2 = 0.9996). The limit of detection (LOD) and quantification (LOQ) were 0.01 and 0.025 µg/ml respectively. The obtained results clearly indicate that the proposed validated method can be used as an alternative method for assay of nystatin.