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Volume 33 Issue 1
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2015  >  33(1): 40-43

ZHANG Xiuli, ZHANG Yujia, WANG Lulu, FANG Xiaqin, CHEN Shaohua, ZHENG Wensheng. Determination method of related substances in risedronate sodium tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(1): 40-43. doi: 10.3969/j.issn.1006-0111.2015.01.010
Citation: ZHANG Xiuli, ZHANG Yujia, WANG Lulu, FANG Xiaqin, CHEN Shaohua, ZHENG Wensheng. Determination method of related substances in risedronate sodium tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(1): 40-43. doi: 10.3969/j.issn.1006-0111.2015.01.010
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Determination method of related substances in risedronate sodium tablets

doi: 10.3969/j.issn.1006-0111.2015.01.010

  • Key Laboratory of Drug Delivery Technology and Novel Formulations of Beijing, Institute of Materia Medica, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100050, China

  • Received Date: 2013-12-11
  • Rev Recd Date: 2014-06-30
  • Objective To establish a HPLC method for determination of related substances of risedronate sodium tablets. Methods The C18 column,5 μm,150 mm×4.6 mm,the buffer solution (3.22 g tetrabutyl ammonium bromide was added to a buffer solution of 1 000 ml 0.05 mol/L ammonium chloride,then adjusted pH to 7.8±0.05 by ammonia)-methanol-acetonitrile =250:50:25 as mobile phase,column temperature:room temperature,flow rate:1.0 ml/min,detection length:254 nm. Results Determined by HPLC at high temperature,acid,alkali degradation,the main peak and the impurity peaks were separated well,and the peaks had a linear relationship,Y=1.28×107X-1.62×105 (r=0.999 9). Conclusion The method was rapid,simple,accurate and sensitive,and suitable for determination of risedronate sodium tablets related substances.
  • [1] 杜 蕾,马培奇.第三代双磷酸盐类药物利塞膦酸钠[J].中国医药情报,2000,6(3):1-4.
    [2] 郑 珩.治疗骨质疏松症新药:risedronate sodium[J].药学进展,1999,23(3):181-182.
    [3] 王 婷,张静霞,程海祺,等.高效液相色谱法测定利福拉齐的有关物质[J].中国抗生素杂志,2012,37(4):284-319.
    [4] 刘明洁, 孙 华.HPLC法测定利塞膦酸钠的含量[J].中国药事,2003,17(3):178-179.
    [5] 郝卫强,刘文英,狄 斌,等. 高效液相色谱法测定利塞膦酸钠片的含量[J].中国药科大学学报, 2001,32(4):286-289.
    [6] 印 平,姚 勇,崔丽华,等.利塞膦酸钠对非骨水泥型全髋关节置换术后早期股骨假体周围骨密度的影响[J].中国骨质疏松杂志, 2013,19(7):732-736.
    [7] 李 蔚,马 嘉,张 妍,等.利塞膦酸钠与羟磷酸盐联合应用治疗绝经后骨质疏松症的实验研究[J].西北药学杂志, 2012,27(5):474-475.
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Determination method of related substances in risedronate sodium tablets

doi: 10.3969/j.issn.1006-0111.2015.01.010
  • Key Laboratory of Drug Delivery Technology and Novel Formulations of Beijing, Institute of Materia Medica, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100050, China
  • Received Date: 2013-12-11
  • Rev Recd Date: 2014-06-30

Abstract: Objective To establish a HPLC method for determination of related substances of risedronate sodium tablets. Methods The C18 column,5 μm,150 mm×4.6 mm,the buffer solution (3.22 g tetrabutyl ammonium bromide was added to a buffer solution of 1 000 ml 0.05 mol/L ammonium chloride,then adjusted pH to 7.8±0.05 by ammonia)-methanol-acetonitrile =250:50:25 as mobile phase,column temperature:room temperature,flow rate:1.0 ml/min,detection length:254 nm. Results Determined by HPLC at high temperature,acid,alkali degradation,the main peak and the impurity peaks were separated well,and the peaks had a linear relationship,Y=1.28×107X-1.62×105 (r=0.999 9). Conclusion The method was rapid,simple,accurate and sensitive,and suitable for determination of risedronate sodium tablets related substances.

ZHANG Xiuli, ZHANG Yujia, WANG Lulu, FANG Xiaqin, CHEN Shaohua, ZHENG Wensheng. Determination method of related substances in risedronate sodium tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(1): 40-43. doi: 10.3969/j.issn.1006-0111.2015.01.010
Citation: ZHANG Xiuli, ZHANG Yujia, WANG Lulu, FANG Xiaqin, CHEN Shaohua, ZHENG Wensheng. Determination method of related substances in risedronate sodium tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(1): 40-43. doi: 10.3969/j.issn.1006-0111.2015.01.010
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