摘要

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 degrees 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 mu g/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 mu g/mL respectively. The results indicate that this validated method can be used as an alternative method for assay of nystatin.

  • 出版日期2015