Quantification of Metoprolol Succinate in balk and tablet formulation by HPLC: Method development and validation

Abstract

The present paper describes a sensitive, precise and accurate HPLC method with UV detection for the quantification of metoprolol succinate in bulk and tablet formulation. Separations were carried out on Inertsil ODS-2 analytical column (150 mm x 4.6 mm, 5 μ particle size). An isocratic elution system was developed using ammonium acetate buffer: acetonitrile: acetic acid [84:15:1 v/v/v]. The pH of the mobile was adjusted to 3.8 with orthophosphoric acid. The elution of the analyte was achieved with a flow rate of 1.0 ml/min. Detection was by UV absorbance at a wavelength of 280 nm. The detector response was linear in the concentration of 10-50 µg/ml (R2 = 0.9997) metoprolol succinate. The limit of detection and limit of quantitation values were found to be 0.0189 μg/ml and 0.0630 μg/ml, respectively. The method was validated following ICH guidelines. All the parameters of validation were found in the acceptance range. The method was successfully applied to the assay of metoprolol succinate in tablets