Fasten, simple, and specific stability of the avant-garde RP-HPLC method for estimation and validation of nystatin in pharmaceutical formulations

  • Dawood CH. Al-Bahadily Clinical labrortary Science department, pharmacy college, Basrah, Iraq
  • Rasool Chaloob Department of Pharmacology and Toxicology, College of Pharmacy, University of Basrah, Iraq
  • Kulood H. Oudah College of Pharmacy, Al-Ayen University, Thi-Qar, Iraq
  • H. N. K. AL-Salman Pharmaceutical Chemistry Department, College of pharmacy, University of Basrah, Iraq
  • Falah Hassan Shari College of Pharmacy, Al-Ayen University, Thi-Qar, Iraq
  • Hussein H. Hussein Pharmaceutical Chemistry Department, College of pharmacy, University of Basrah, Iraq

Abstract

In this study, a simple and reliable stability-indicating RP-HPLC method was developed and validated for the analysis of Nystatin in the pharmaceuticals. The chromatographic separation was performed in the isocratic mode on an Ion Pac column; Arcus EP‑C18; 5μm, 4.6×250 mm, 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 with UV detection at 305 nm. The flow rate was set at 1.0 mL/min. The HPLC analysis method was validated in terms of linearity, precision, accuracy, specificity, and sensitivity, according to International Conference on Harmonization (ICH) guidelines. The results indicated that the retention time was 8 min, and no interferences were observed from the formulation excipients and stress degradation products.  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 the assay of nystatin. This validated HPLC method could be used for routine analysis, quality control, and the stability of analysis of Nystatin formulations.

Keywords: Nystatin (NYS), pharmaceuticals varied, antifungal medication

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Published
2019-11-30
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How to Cite
Dawood CH. Al-Bahadily, Rasool Chaloob, Kulood H. Oudah, H. N. K. AL-Salman, Falah Hassan Shari, & Hussein H. Hussein. (2019). Fasten, simple, and specific stability of the avant-garde RP-HPLC method for estimation and validation of nystatin in pharmaceutical formulations. International Journal of Research in Pharmaceutical Sciences, 10(4), 3717-3727. https://doi.org/10.26452/ijrps.v10i4.1760
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Original Articles
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