Simultaneous Determination of Clobetasol Propionate and Calcipotriol in a Novel Fixed Dose Emulgel Formulation by LC-UV


BADILLI F. U., AMASYA G., ÖZKAN S. A., Tarimci N.

CHROMATOGRAPHIA, cilt.76, sa.3-4, ss.133-140, 2013 (SCI-Expanded) identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 76 Sayı: 3-4
  • Basım Tarihi: 2013
  • Doi Numarası: 10.1007/s10337-012-2380-8
  • Dergi Adı: CHROMATOGRAPHIA
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.133-140
  • Anahtar Kelimeler: RP-LC, UV detection, Clobetasol propionate, Calcipotriol, Emulgel, Fixed-dose combination, PERFORMANCE LIQUID-CHROMATOGRAPHY, BETAMETHASONE DIPROPIONATE GEL, NANOSTRUCTURED LIPID CARRIERS, SOLVENT DIFFUSION METHOD, COSMETIC PRODUCTS, TOPICAL DELIVERY, DOUBLE-BLIND, PSORIASIS-VULGARIS, SCALP PSORIASIS, COMBINATION
  • Ankara Üniversitesi Adresli: Evet

Özet

A new, rapid, selective, cheap and simple RP-LC method has been developed and validated for the simultaneous determination of clobetasol propionate and calcipotriol mixtures in bulk drugs (raw materials) and in a novel-fixed dose emulgel formulation. Separation was carried out using a NovaPak C18 column with methanol:water (74:26 v/v) as mobile phase for isocratic elution at a flow rate of 1.0 mL min(-1). The column temperature was set at 25 A degrees C. Calibration curves were established ranging between 0.5 and 20 mu g mL(-1) and 0.5 and 10 mu g mL(-1) for clobetasol propionate and calcipotriol, respectively. Limit of detection and limit of quantification values of the method was found as 0.16 and 0.48 mu g mL(-1) for clobetasol propionate and 0.10 and 0.30 mu g mL(-1) for calcipotriol, respectively. The method was validated in accordance with ICH guidelines and obtained results proved that the proposed method was precise, accurate, selective and sensitive for the simultaneous analysis of clobetasol propionate and calcipotriol. The proposed method can be easily applied for the simultaneous determination of clobetasol propionate and calcipotriol in prepared emulgel formulations. The obtained validation results showed that the RP-LC method is suitable for routine quantification of clobetasol propionate and calcipotriol in emulgel formulations with high precision and accuracy.