Stability Indicating HPTLC Determination of Triamcinalone Acetonide in Bulk Drug and Sterile Injectable Suspension

Abstract

A sensitive, accurate, precise and stability indicating high-performance thin layer chromatographic method was developed and validated for analysis of triamcinalone acetonide (TRIA) in bulk drug and sterile injectable suspension. The method employed HPTLC aluminum precoated plates with silica gel 60F-254 as the stationary phase. The solvent system consisted of Toluene: ethyl acetate: ammonia solution (33:67:0.1 %v/v). This system was found to give compact bands for TRIA (R f value 0.38 ± 0.02). TRIA was subjected to acid, alkali and neutral hydrolysis, oxidation, sun light and dry heat treatment. The degraded products were well separated from the pure drug with notably different R f values. CAMAG semi-automatic HPTLC used for the analysis. Densitometric analysis of TRIA was carried out in the absorbance mode at 240 nm. The linear regression data for the calibration plots showed good linear relationship with correlation coefficient 0.9996 ±/ 0.001 in the concentration range of 100.0-2000.0 ng spot -1 . The values of slope and intercept were 9.7841 and -86.13 respectively. The method was validated for precision, accuracy, robustness, and recovery. The limits of detection and quantitation were 33.0 and 100.0 ng spot -1 respectively. As the method could effectively separate the drug from its degradation products, it can be employed as a routine stability indicating assay method. Key words: Triamcinalone Acetonide (TRIA), HPTLC, Stability indicating assay method, Degradation, ICH, Validation.