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HPLC法测定多潘立酮口服混悬液的含量及有关物质
引用本文:董煜,王冬,钱小平. HPLC法测定多潘立酮口服混悬液的含量及有关物质[J]. 中国药品标准, 2011, 12(4): 274-276
作者姓名:董煜  王冬  钱小平
作者单位:大连市药品检验所大连116021
摘    要:目的:用高效液相色谱法测定多潘立酮口服混悬液的含量及有关物质.方法:采用C18柱;流动相为0.5%醋酸胺溶液-甲醇(40:60);检测波长280nm.用外标法测定含量,不加校正因子的自身对照法测定有关物质.结果:有关物质浓度在0.623μg~1.870 μg·mL-1,含量测定浓度在49.86~149.58μg·mL-...

关 键 词:高效液相色谱法  多潘立酮  混悬液  有关物质

Determination of Domperidone Suspension and Its Related Substances by HPLC
Dong Yu,Wang Dong and Qian Xiao-ping. Determination of Domperidone Suspension and Its Related Substances by HPLC[J]. , 2011, 12(4): 274-276
Authors:Dong Yu  Wang Dong  Qian Xiao-ping
Affiliation:Dong Yu,Wang Dong,Qian Xiao-ping(Dalian Institute for Drug Control,Dalian 116021)
Abstract:Objective: To establish an HPLC method for determination of the content and the related substances of Domperklone Sus- pension. Methods: HPLC method, the chromatographic colum was Alhima C18(4. 6 mm × 150 mm ,5 μm). The mobile phase consis- ted of 0. 5% ammonium acetate solution-methanol (40: 60) ; detecting wavelength at 280 nm. Results: the linear rangea were 0. 623 μg - 1. 870 μg · mL-1 (r =0. 999 7) for the related substances, 49. 86 · 149.58 μg · mL^-1 (r =0. 999 9)for the Demperidone, the mean recovery was 99. 92%, RSD of the five samples was 1.2%. Conculsion: The method was sensitive,accurate and high specific for content determination of Domperidone and its related substances in Domperidone Suspension.
Keywords:HPLC  Demperidone  suspension  related substances  
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