Development and Validation of a Stability-Indicating Reversed-Phase Liquid Chromatographic Method for the Simultaneous Determination of Methylprednisolone Aceponate and Benzyl Alcohol in Cream Formulation


CÜCÜ A., Yılmaz D. Ç., Tecimen F. G., KUL A.

Biomedical Chromatography, cilt.40, sa.5, 2026 (SCI-Expanded, Scopus) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 40 Sayı: 5
  • Basım Tarihi: 2026
  • Doi Numarası: 10.1002/bmc.70429
  • Dergi Adı: Biomedical Chromatography
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, Chemical Abstracts Core, Chimica, Compendex, EMBASE, MEDLINE
  • Anahtar Kelimeler: benzyl alcohol, core-shell column, high-performance liquid chromatography, methylprednisolone aceponate, stability-indicating methods
  • İstanbul Üniversitesi Adresli: Evet

Özet

Methylprednisolone aceponate (MPA) is a nonhalogenated, diester corticosteroid, specifically designed to treat eczema. The amount of benzyl alcohol (BA), an excipient, is quite high in the cream formulation of MPA; therefore, the simultaneous determination of MPA, active ingredient, and BA is important. Chromatographic analysis was performed on an Agilent Poroshell 120 EC-C18 (100 × 2.1 mm 2.7 μm) column using acetonitrile–water (40:60, v/v) mixture as mobile phase with isocratic elution. The diode array detector (DAD) was set at 245 and 258 nm. The column was thermostated at 40°C ± 1°C. A flow rate of 0.5 mL/min was used to elute the analyte from the column. The calibration curve was linear in the concentration range 0.17–4.20 μg/mL for MPA and 1.50–35.0 μg/mL for BA. The R2 values for MPA and BA were found to be 0.9989 and 0.9999, respectively. The limit of detection was found to be 0.048 μg/mL for MPA, 0.46 μg/mL for BA, and the limit of quantification was found to be 0.17 μg/mL for MPA and 1.50 μg/mL for BA. MPA was exposed to stress conditions, and the stressed samples were analyzed using the proposed method, which can effectively separate MPA from its degradation products.