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采用毛细管胶束电动色谱法和高效液相色谱法测定包衣片中罗格列酮的含量。

Determination of rosiglitazone in coated tablets by MEKC and HPLC methods.

作者信息

Gomes Patrícia, Sippel Juliana, Jablonski André, Steppe Martin

机构信息

Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Av. Ipiranga 2752 Lab.402, Porto Alegre 90610-000, RS, Brazil.

出版信息

J Pharm Biomed Anal. 2004 Nov 19;36(4):909-13. doi: 10.1016/j.jpba.2004.08.019.

Abstract

Micellar electrokinetic chromatographic (MEKC) and high-performance liquid chromatographic (HPLC) methods were developed and subsequently validated for the determination of rosiglitazone (RSG) in coated tablet, a potent new oral antihyperglicemic agent. The electrophoretic separation was performed in a fused-silica capillary of total length 48.0 cm (effective length 39.5 cm, 75 microm i.d.) using 10 mM sodium tetraborate buffer (pH 9.0) containing 30 mM sodium dodecyl sulfate (SDS) as the background electrolyte (BGE). The separating voltage used was of 20 kV at 25 degrees C and the diode array detector was set at 247 nm. The MEKC method was compared with HPLC method using a RP-18 column (125 x 4.0mm i.d.) eluted with a mobile phase consisting of mixture of 25 mM potassium dihydrogen phosphate buffer and acetonitrile (55:45, v/v), adjusting the pH to 6.2 with dilute potassium hydroxide. Statistical analysis by Student's t-test showed no significant differences between the results obtained by two methods. The results indicated that MEKC can be used an alternative method to HPLC for the determination of rosiglitazone in pharmaceutical dosage form.

摘要

开发了胶束电动色谱法(MEKC)和高效液相色谱法(HPLC),随后对其进行验证,用于测定包衣片中的罗格列酮(RSG),罗格列酮是一种新型强效口服抗糖尿病药物。在总长48.0 cm(有效长度39.5 cm,内径75μm)的熔融石英毛细管中进行电泳分离,使用含30 mM十二烷基硫酸钠(SDS)的10 mM硼酸钠缓冲液(pH 9.0)作为背景电解质(BGE)。在25℃下使用的分离电压为20 kV,二极管阵列检测器设置在247 nm。将MEKC方法与使用RP - 18柱(125×4.0mm内径)的HPLC方法进行比较,用由25 mM磷酸二氢钾缓冲液和乙腈(55:45,v/v)的混合物组成的流动相洗脱,用稀氢氧化钾将pH调节至6.2。通过学生t检验进行的统计分析表明,两种方法获得的结果之间没有显著差异。结果表明,MEKC可作为HPLC的替代方法用于测定药物剂型中的罗格列酮。

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