RP-HPLC Stability-Indicating Assay Method for Talinolol and Characterization of its Degradation Products

Abstract

A reversed-phase high-performance liquid chromatographic method is developed and validated for the quantitative determination of talinolol and to characterize its degradation products. A very good resolution between peaks is achieved using a C18 column at 40°C. The mobile phase comprises of a mixture of acetonitrile and potassium dihydrogen orthophosphate buffer (pH 4.4) in the ratio of 27:73 (v/v). The method is validated with respect to linearity, accuracy, precision, robustness, and forced degradation studies, which further proved the stability indicating power. During the forced degradation studies, talinolol is observed to be labile to hydrolytic stress and thermal stress (in the solution form). However, it is stable to the oxidative, photolytic, and thermal stress (in the solid form). The degraded products formed are investigated by electrospray ionization (ESI), time-of-flight mass spectrometry, nuclear magnetic resonance, and infrared spectroscopy. A possible degradation pathway is outlined based on the results. The method is found to be sensitive with a detection limit of 0.125 μg/mL and a quantitation limit of 0.378 μg/mL. The method is also demonstrated to be robust, as it is resistant to small variations of chromatographic variables such as pH, mobile phase composition, flow rate, and column temperature.