HPLC Determination of Terbutaline Sulfate Impurity ��
LIU Zhao-xia1,HUA Xiao-yi2,CHENG Qi-lei1, HE Lan1*,DING Li-xia3*
1. National Institutes for Food and Drug Control, Beijing 100050, China; 2.Wuxi Institute for Drug Control, Wuxi 214028, China; 3. Chinese Pharmaceutical Association, Beijing 100022, China
Abstract��OBJECTIVE To establish a qualitative and quantitative HPLC method for the determination of impurity ��in tebutaline sulfate.METHODS The Kromasil C18column(4.6 mm��150 mm,5 ��m)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 ��L.Area normalization method with correction factor was used for the quantitative analysis of the impurity ��. RESULTS Under the separation condition,the impurity �� was completely separated from the principal components. The calibration curve showed good linearity in the concentration range of 0.10-579 ��g��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 ��in 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.
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2016, Vol. 51 
