HPTLC Analysis and Force Degradation Study of Tapentadol Hydrochloride in Bulk and Its Pharmaceutical Formulation

Abstract

To achieve easy, sensitive reproducible high-performance thin-layer chromatography (HPTLC) densitometric method was developed and validated for the determination of tapentadol HCl and its pharmaceutical formulation. In this method the ethyl acetate: methanol: ammonia (6:4:0.5v/v/v) were used as mobile phase for chromatographic separation of the drug. The method has been performed on precoated silica Tab 60F254 Merck plates and the Rf value was calculated at 0.47 for tapentadol HCL. The calibration curve was plotted in the concentration range of 500-2500ng/ml. The limits of quantitation and limit of detection were found to be 0.07 and 0.23μg/ml respectively. The correlation coefficient (R2) value was obtained at 0.998 for tapentadol HCL. The percent recoveries were obtained between 99.97 to 101.13% for tapentadol HCl. The method has been validated according to ICH guidelines for linearity, precision, accuracy, specificity, and robustness. The degradation behavior was recorded under acidic, basic, neutral, oxidative, photolytic, and thermal stress conditions. The degradation products were well separated from the pure drug under the optimized conditions. As the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating method for tapentadol HCl.