Stabilityindicating High Performance Thin Layer Chromatography /densitometry estimation of Formoterol fumarate dihydrate in bulk and capsules

Abstract

Novel, simple, rapid and reliable High-Performance Thin-Layer Chromatographic (HPTLC) methods were developed and validated for the analysis of Formoterol Fumarate Dihydrate (FFD) in bulk and in in-house tablet formulation. HPTLC quantitation of FFD was done at UV detection of 281 nm and analysis was performed on (10 cm 10 cm) aluminium sheets precoated with silica gel 60-F ₂₅₄ (E. Merck) as stationary phase and ethyl acetate: methanol: triethylamine (3.2:1.5:0.3 v/v ) as mobile phase. Quantitation by HPTLC method was performed over the concentration range of 400 - 900 ng/band. The HPTLC method resulted into compact and well resolved band for FFD at retention factor ( R_f ) of 0.51 0.3. Linear regression analysis data for calibration of HPTLC method represented good linear relationship with regression coefficient; r ² = 0.999. The developed methods were validated for precision, robustness, ruggedness, accuracy, sensitivity as per guidelines laid by International Conference on Harmonisation (ICH). FFD was subjected to acid and alkali hydrolysis, oxidation, neutral, photo and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation, and thermal conditions. This indicates that the drug is susceptible to acid, base, oxidation and thermal conditions. The degraded product was well resolved from the pure drug with significantly different R _f value. Statistical analysis proved that the developed methods were precise, robust, sensitive and accurate and can be used effectively for the analysis of FFD in bulk and pharmaceutical formulations.