Rapid and sensitive bioanalytical stability-indicating method for quantification of talinolol, a selective β1...

The current study evaluates the ultra high performance liquid chromatography (UHPLC) method for the quantification of talinolol in lipid-based formulations. A simple, rapid, reliable and precise reversed phase UHPLC method has been developed and validated according to the regulatory guidelines, which was composed of isocratic mobile phase; acetonitrile and phosphate buffer saline (pH 4.5) with a flow rate of 0.4 mL/min, and column HSS C18 (2.1 x 50 mm, 1.8 μm). The detection was carried out at 245 nm. The developed UHPLC method was found to be rapid (1.8 min run time), selective with high resolution of talinolol peak (0.88 min) from different lipid matrices and highly sensitive (limit of detection and lower limit of quantification were 0.14 ppm and 0.5 ppm, respectively). The linearity, accuracy and precision were determined as acceptable over the concentration range of 0.5-100 ppm for talinolol. The results showed that the proposed UHPLC method can be used for the estimation of talinolol in lipid-based formulation by indicating its purity and stability with no interference of excipients or related substances of active pharmaceutical ingredient.