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

Authors

  • Arash Mahboubi Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Farnaz Shokraneh Department of Pharmaceutics, Pharmaceutical Sciences Branch, Islamic Azad University (IAU), Tehran, Iran.
  • Mehdi Ramin Quality Assurance Lab, Jaber Ebne Hayyan Pharmaceutical Company, Tehran, Iran
  • Ramin Asgharian Department of Pharmaceutics, Pharmaceutical Sciences Branch, Islamic Azad University (IAU), Tehran, Iran.
Abstract:

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.

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Journal title

volume 14  issue supplement

pages  43- 49

publication date 2015-03-01

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