Stability-indicating assay method for desonide in bulk and pharmaceutical formulation by HPTLC

Abstract

HPTLC method was developed for estimating the content of desonide in bulk and pharmaceutical formulation. Desonide is a topically applied low potency anti-inflammatory corticosteroid. In the proposed method pre-coated HPTLC aluminum plates with silica gel 60 F254 and ethyl acetate: n-hexane: glacial acetic acid in the proportion of 7:3:0.1, v/v/v is used as stationary and mobile phase, respectively. The method was found to give compact and symmetrical band for desonide at retention factor (Rf) 0.48 ± 0.02. Densitometric scanning was performed at 253 nm in the concentration range of 200–1200 ng/band (r2 = 0.9980). Validation of developed method is carried as per ICH Q2 (R1) guidelines. Desonide was subjected for stability study at acid, alkali, oxidation and photo-degradation condition. The degradation products were well resolved from the desonide with significantly different Rf value. Statistical analysis proven that the proposed method is repeatable, selective and accurate for estimating the content of desonide. The results of present study clearly shown that the proposed HPTLC method can be applied for estimating the content of desonide in bulk drug and pharmaceutical formulation.

Keywords

• Desonide
• HPTLC
• Stability-indicating assay method