| 利塞膦酸钠片有关物质的方法学研究 |
| 投稿时间：2013-12-11 修订日期：2014-06-30 点此下载全文 |
| 引用本文：张秀立,张宇佳,王璐璐,方夏琴,陈少华,郑稳生.利塞膦酸钠片有关物质的方法学研究[J].药学实践杂志,2015,33(1):40~43 |
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| 基金项目:十一五国家科技重大专项"重大新药创制"项目(2009ZX09301003-008-001) |
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| 中文摘要:目的 建立测定利塞膦酸钠片有关物质的高效液相色谱法。方法 采用ODS C18色谱柱(5 μm,150 mm×4.6 mm),以缓冲液(取四丁基溴化铵3.22 g 加入1 000 ml 0.05 mol/L氯化铵缓冲液中,用氨水调pH至7.8±0.05)-甲醇-乙腈(250:50:25)为流动相;柱温:室温;流速:1.0 ml/min;检测波长:254 nm。结果 在高温、酸、碱、氧化、强光降解下用HPLC测定,各杂质峰和主峰均有较好的分离效果,线性关系为Y=1.28×107X-1.62×105(r=0.999 9),线性良好,稳定性良好。结论 该方法测定快速、简单、准确,灵敏度高,适用于利塞膦酸钠片有关物质的测定。 |
| 中文关键词:利塞膦酸钠 有关物质 高效液相色谱法 |
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| Determination method of related substances in risedronate sodium tablets |
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| 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. |
| keywords:risedronate sodium related substances HPLC |
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