Development of stability indicating HPLC method for the separation and validation of enantiomers of miconazole


Bounoua N., Sekkoum K., GÜMÜŞTAŞ M., Belboukhari N., ÖZKAN S. A.

CHIRALITY, cilt.30, sa.6, ss.807-815, 2018 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 30 Sayı: 6
  • Basım Tarihi: 2018
  • Doi Numarası: 10.1002/chir.22858
  • Dergi Adı: CHIRALITY
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.807-815
  • Anahtar Kelimeler: chiral separation, enantiomer, HPLC, miconazole, polysaccharide-based chiral column, validation
  • Ankara Üniversitesi Adresli: Evet

Özet

A selective and sensitive stability indicting HPLC method was developed for the analysis of enantiomers of miconazole. For this purpose, six different polysaccharide-based chiral columns were evaluated. Optimization was performed using several polar organic and alcohol-hydrocarbon mobile phases. As a result of optimization studies, the analysis was carried out using Lux Cellulose-3, methanol as a mobile phase at a flow rate of 1mLmin(-1), and the detection wavelength was arranged to 230nm. Developed method has been fully validated according to International Council on Harmonization guidelines. Method was found linear in the concentration range of 1 to 200gmL(-1). Coefficient of determination (R-2) was calculated as 0.9996, intraday precision of the method was found with the RSD% of 0.56, and the recovery of the method was calculated close to 100%. Furthermore, some other validation parameters like specificity, selectivity, LOD, and LOQ were also investigated. Stability indicating capability of this method was shown by forced degradation studies, and the run time for each analysis was less than 6minutes. As a result, simple, fast, reliable HPLC method was developed for the separation and determination of the enantiomers of miconazole. Applicability of the developed method was shown with the application of marketed pharmaceutical preparations.