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离子对反相高效液相色谱法测定十取代芦丁硫酸钠含量及有关物质 被引量:1

Determination of RDS and Relative Impurities by IP-RP-HPLC
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摘要 目的建立高效液相色谱测定十取代芦丁硫酸钠含量及有关物质。方法采用XDB-C8色谱柱,流动相:乙腈-25 mmol.L^-1TBAB缓冲液(KH2PO410 mmol.L^-1,三乙胺调节pH7.5)=48∶52,流速:1.0 mL.min^-1,检测波长:λ=254 nm;柱温:25℃。结果在2.0-200.0μg.mL^-1浓度范围内峰面积与浓度呈现良好的线性关系,回归方程为:A=12158.5C+43.63,相关系数r=0.999 9。日内精密度和日间精密度均小于3.5%。结论本法专属性良好,符合十取代芦丁硫酸钠的含量测定和有关物质检查的要求。 OBJECTIVE To establish a HPLC method for determination of RDS and relative impurities. METHODS Agilent Cs column was used. The mobile phase consisted of acetonitrile and 25 mmol·L^-1 phosphate buffer solution containing 20 mmol·L^-1 TBAB ( pH 7, 5 ) (48: 52, v/v) with flow rate of 1.0 mL · min^-1, The detection wavelength was set at 254 nm. RESULTS The linear range of cadibration curve was 2.0 -200.0μg· mL^-1 , A = 12158.5C +43, 63, r = 0.999 9. The intra-day and inter-day RSD were less than 3.5%, CONCLUSION The proposed method was simple, precise and reproducible; the decomposed product can be separated as well, Therefore, the quality of RDS can be effectively controlled.
出处 《中国现代应用药学》 CAS CSCD 北大核心 2007年第3期227-229,共3页 Chinese Journal of Modern Applied Pharmacy
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