Determination of torasemide and its related substances in toraesmide tablets by high performance liquid chromatography
NI Chong~1,MIAO Yu-shan~2,YIN Rong-sheng~2,NI Tao~3,JIANG Jin-yuan~3 (1. China Pharmaceutical University Pharmaceutical Co Ltd, Nanjing JIANGSU 210 0 09,China; 2. Department of Pharmacy, Zhongda Hospital, Southeast University, Na njing JIANGSU 210009,Chin a; 3. Nanjing Zechen Science and Technology Co Ltd,Nanjing JIANGSU 210009,Chi na)
AIM: To establish the HPLC for determining torasemide and its re lated su bstances in torasemide tablets. METHODS: The HPLC was performed on Shimpack CLC(M)C_(18)(250 mm×4.6 mm,5 μm) column. The mobile phase consisted of met han ol and 0 .02 mol·L~(-1) monobasic potassium phosphate buffer(65 ∶35). The flow rate was 0.9 mL ·min~(-1). The detection wavelength was set at 291 nm. RESULTS: The assay showed good linea r correlation over the range of 2-24 mg·L~(-1) (r=0.999 9). The average recovery rate was 99.73 %,with the RSD= (0.17 %) (n=9). The concentrotions of torasemide in torasemide tablets wer e 99.8 0 %,100.10 %,(100.40 %) and the related substances in torasemide tablets were 0.58 %,0.45 %,0.39 % ,respec tively. CONCLUSION: The HPLC is accurate,sensitive and repeatable with val uabl e application to the quality control of torasemide tablets.
【CateGory Index】： R927