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RP-HPLC法测定盐酸罗格列酮含量及有关物质 被引量:11

RP-HPLC Determination of Content and its Related Substances of Rosiglitazone
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摘要 目的:采用高效液相色谱法测定盐酸罗格列酮的含量及有关物质。方法:色谱柱为岛津公司Shim-pack C_(18)柱(250 mm×4.6 mm,5 μm),以乙腈-0.01 mol·L^(-1)醋酸铵缓冲液(40:60,用醋酸调节pH=6.0)为流动相,流速1.0 mL·min^(-1),检测波长为244 nm。结果:盐酸罗格列酮在40-160μg·mL^(-1)范围内呈良好的线性关系,r=0.9999;最低检出限0.04 ng;日内精密度(RSD<0.5%)与日间精密度(RSD<1.0%)良好。结论:本方法简便、快速,结果准确、可靠。 Objective:To determine the content and the related substances of rosiglitazone by RP-HPLC. MethodS:The separation was performed on a Shim-pack C_(18) column(250mm×4.6mm,5μm) ,the mobile phase was composed of acetonitrile-0.01 mol·L^(-1) ammonnium acetate (40:60, to make up the pH 6.0 with acetic acid) and detection at 244nm, the flow rate was 1.0 mL·min^(-1). Results:The linear range of the determination by RPHPLC was 40-160 μg·mL^(-1),the correlation coefficient was 0.9999;The least detective range was 0.04ng;The precision in a day(RSD<0.5% ) and during the day (RSD< 1.0% ) were good. Conclusion:The method is simple,rapid and the results is accurate.
出处 《药物分析杂志》 CAS CSCD 北大核心 2005年第1期104-106,共3页 Chinese Journal of Pharmaceutical Analysis
关键词 罗格列酮 有关物质 RP-HPLC法 含量 高效液相色谱法 RSD 缓冲液 盐酸 乙腈 最低检出限 rosiglitazone determination related substances RP-HPLC
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