HPLC法测定盐酸格拉司琼口腔崩解片的含量及有关物质  

Determination of Content of Granisetron Hydrochloride Orally Disintegrating Tabletsand its Related Substances by HPLC.

作　　者：沙吉达[1] 郑莉莉[2] 

机构地区：[1]福建省药品检验所,福州350001 [2]福建中医学院,福州350003

出　　处：《海峡药学》2006年第3期51-53,共3页Strait Pharmaceutical Journal

摘　　要：目的 建立盐酸格拉司琼口腔崩解片的含量及有关物质的HPLC测定法.方法 采用氰基柱 Luna 5μ -CN（250 mm×4.6 mm）色谱柱;流动相：醋酸钠缓冲液[0.05 mol·L^-1,含0.25%（ml·mL^-1）三乙胺,用冰醋酸调节pH至6.0]-甲醇（52：48）;流速：1.0ml·min^-1;检测波长：302 nm.结果 线性范围：盐酸格拉司琼在0.1014～1.014mg范围内线性良好,r=0.9999.平均回收率101.02%,RSD=0.58%（n=9）.结论 本法简便,快速、结果准确.OBJECTIVE A HPLC method for the determination of content of Granisetron Hydrochloride Orally Disintegrating Tablets and its related substances was established. METHODS A Luna 5μ CN column was used with sodium acetate buffer [0.05mol·L^-1,with 0. 25% （ml ·ml^-1） Triethlamine,pH adjusted to 3.5 by acetic acid] and methanol（52 ＂ 48） as mobile phase. RESULTS The flow rate was 1.0ml ·min^-1 and detection wavelength 302nm. The linear range of Granisetron Hydrochloride was 0. 1014～ 1. 014mg, r= 0. 9999. The average recovery rate was 101.01%, The corresponding RSD = 0. 6%.CONCLUSION The method was simple, fast and accurate.

关 键 词：HPLC 盐酸格拉司琼 有关物质 含量测定 

分 类 号：R927.4[医药卫生—药学]