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高效液相色谱法测定格列吡嗪片的含量和有关物质
引用本文:曹玲,王玉,张胜义.高效液相色谱法测定格列吡嗪片的含量和有关物质[J].安徽大学学报(自然科学版),2003,27(3):87-91.
作者姓名:曹玲  王玉  张胜义
作者单位:1. 江苏省药品检验所,江苏,南京,210008
2. 安徽大学,化学化工学院,安徽,合肥,230039
摘    要:建立了格列吡嗪片的含量测定及有关物质的高效液相色谱方法。采用Shim-PackVP-ODS为色谱柱(4.6mm×15cm,5μm),以0.05mol L磷酸二氢钠溶液-甲醇(50∶50)为流动相;流速为1.0mL min,紫外检测波长为276nm。对格列吡嗪及杂质Z分别进行了线性、回收率、日内和日间精密度以及溶液稳定性等试验,结果表明该方法简便、快捷,专属性强,结果准确可靠。

关 键 词:格列吡嗪片  含量测定  有关物值  反相高效液相色谱法
文章编号:1000-2162(2003)03-0087-05

Determination of the Content and the Related Substances of Gelipizide Tablets by HPLC
Abstract:The HPLC method for the determination of gelipizide t ablets and related substances was established. Shim-pack VP-ODS column (4.6mm×1 50mm, 5μm) was used and the mobile phase was 0.05mol/L sodium dihydrogen phosph ate-methanol(50:50), at a flow rate of 1 ml/min. The detection wavelength was 27 6nm. The linearity, recovery, intra and inter-day precision, gelipizide solution stability and impurity Z were studied respectively. The method is simple, fast and the precision is satisfactory.
Keywords:gelipizide tablets  determination  related substance s  RP-HPLC
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