RP-HPLC-PDA Method for the Analysis of Terbutaline sulphate in Bulk, Dosage forms and in Dissolution samples

The aim of the present work was to develop and validate a simple, efficient, economical and LC-MS compatible method for the analysis of Terbutaline sulphate in bulk, dosage forms and in dissolution samples of Terbutaline sulphate tablets by reverse phase high pressure liquid chromatography. A C18 reverse phase column (Phenomenex) of 250 x 4.6mm dimensions and 5µm particle size with mobile phase containing 15mM ammonium acetate: methanol (70:30% v/v) was used at isocratic mode binary pump and eluents were monitored at 220nm. The retention time of Terbutaline sulphate was 4.1min and showed a good linearity in the concentration range of 2-10µg/mL with a correlation coefficient >0.999. The validation characteristics included specificity, linearity, and limit of detection, limit of quantification, precision, robustness and stability. Validation acceptance criteria were met in all cases. The percent recoveries ranged between 98-102%, RSD