ABSTRACT
OBJECTIVE: To establish a qualitative and quantitative HPLC method for the determination of impurity Iin tebutaline sulfate. METHODS: The Kromasil C18 column(4.6 mm×150 mm,5 μm) was used as the analysis column;buffer solution [dissolving 4.23 g of sodium hexanesulfonate in 770 mL of 0.050 mol·L-1 ammonium formate solution (pH 3)]-methanol (77:23) was used as the mobile phase. The flow rate was 1.0 mL·min-1, the column temperature was maitained at 30℃, the detection wavelength was set at 276 nm,and the injectiong volume was 20 μL. Area normalization method with correction factor was used for the quantitative analysis of the impurity I. RESULTS: Under the separation condition, the impurity I was completely separated from the principal components. The calibration curve showed good linearity in the concentration range of 0.10-579 μg·mL-1(r=1.000 0). The correction factor was 3.6. CONCLUSION: The area normalization method with correction factor developed in the paper can be used for the qualitative and quantitative analysis of the impurity Iin terbutaline sulfate, which can not only solve the problem of the availability of impurity reference standards, but also reflect the actual contents of impurity. The method provides an efficient and convenient method for quality control of terbutaline sulfate.