HPLC法测定盐酸格拉司琼的有关物质

目的：用 HPLC法测定盐酸格拉司琼的有关物质。方法采用终端封尾的十八烷基硅胶柱（250 mm ×4．6 mm ，5μm）；以水-乙腈（取1．6 mL磷酸，置于800 mL水中，加200 mL乙腈和1 mL己胺，用新蒸三乙胺调节pH至7．5±0．05）为流动相，检测波长为305 nm。结果在3．048～8．128μg · mL -1范围内，质量浓度与峰面积线性关系良好，r＝1（n＝6）；精密度 RSD为0.2％（n＝6）；稳定性RSD为1．3％；最小检出量为0．10 ng。结论该法简便、准确、专属性强。

Determination of the related substances in granisetron hydrochloride by HPLC

Objective To determine the content of the related substances in granisetron hydrochloride by HPLC .Methods An end-capping column of octadecylsilyl silica gels （250 mm × 4 .6 mm ,5 μm） was used while water and acetonitrile （taking 1 .6 mL phos-phate into 800 mL water ,adding 200 mL acetonitrile and 1 mL hexyl amine ,with new steamed triethylamine to adjust pH to 7 .5 ± 0 .05） was used as the mobile phase .The detection wavelength was set at 305 nm .Results Peak area was linear with the concen-tration in the range of 3 .048-8 .128 μg · mL -1 ,r=1 （n=6） .Precision RSD was 0 .2% （n=6）;and the stability RSD was 1 .3% . The Limit of detection was 0 .10 ng .Conclusion The method is simple ,convenient ,accurate ,and shows strong specificity .