Stability Indicating High Performance Thin Layer Chromatographic Method for the Determination of Tramadol Hydrochloride in Pharmaceutical Formulation

Abstract

The proposed stability indicating method for the determination of tramadol hydrochloride by high-performance thin-layer chromatography in the pharmaceutical formulations was found to be specific, precise, and validated. The stationary phase employed was a precoated silica gel 60 F₂₅₄ aluminum TLC plate. Several mobile phase combinations of varying polarity of solvent were tried for the method development, as well as for the resolution of degradation products from the parent densitogram of drug. Finally, the mobile phase containing a mixture of ethyl acetate:methanol:ammonia (9:0.8:0.5 v/v/v) was found to be satisfactory for the resolution of degradation products from the parent drug. Densitometric analysis of tramadol hydrochloride was carried out in the reflectance–absorbance mode at 271 nm. The R_f value of the drug was obtained at 0.64 ± 0.02 with sharp symmetrical peak. The degraded products formed under acidic, oxidative, and an alkali conditions were strongly retained. Linear relationships between concentration of analyte and corresponding peak area were observed over the range of 1000–6000 ng at the selected wavelength with an R² value of 0.999 ± 0.0007. The validation for specificity, precision, robustness, and recovery of the method was also performed. The present method effectively separated the tramadol hydrochloride from its degradation products.

Keywords:

• degradation products
• HPTLC
• stability indicating method
• stress degradation
• tramadol hydrochloride
• TLC