Determination of Terbutaline Sulfate in Phospholipid Complex by High Performance Liquid Chromatography

A method for the determination of terbutaline sulfate in phospholipid complex by high performance liquid chromatography (HPLC) was established. Self-made terbutaline sulfate phospholipid complex of 210 mg was dissolved with methanol and made its volume up to 100 mL, and then 1 mL of the above solution was diluted with a mixture of acetonitrile and 6.5 mmol·L^-1 sodium octane sulfonate solution at volume ratio of 35∶65 (pH 3.4). AQUASIL^®-C₁₈ column (250 mm×4.6 mm, 5 μm) was used as the stationary phase, and a mixture of acetonitrile and 6.5 mmol·L^-1 sodium octane sulfonate solution at volume ratio of 35∶65 (pH 3.4) was used as the mobile phase for isocratic elution. Terbutaline sulfate was determined by UV absorption detector at 280 nm, and external standard method was used for quantitative analysis. As shown by the results, linear relationship between mass of terbutaline sulfate and its peak area was kept in the range of 0.104 3-10.429 0 μg, with detection limits (3S/N) of 1.565 9 ng. 104.3 mg·L^-1 terbutaline sulfate reference solution was determined 5 times, and RSD of peak area was 0.18%. Recovery test was made on terbutaline sulfate phospholipid complex by standard addition method, giving results in the range of 98.5%-100%. This method was applied for the determination of 3 terbutaline sulfate phospholipid complex samples, and the recombination rate was calculated in the range of 89.04%-91.82%.