Development and Validation of a Stability Indicating HPLC Method for Determination of Granisetron

被引:5
作者
Souri, Effat [1 ,2 ]
Kargar, Zahra [1 ,2 ]
Saremi, Shahrooz [2 ,3 ]
Ravari, Nazanin Shabani [1 ,2 ]
Alvandifar, Farhad [1 ,2 ]
Amanlou, Massoud [1 ,2 ]
机构
[1] Univ Tehran Med Sci, Fac Pharm, Dept Med Chem, Tehran 141556451, Iran
[2] Univ Tehran Med Sci, Pharmaceut Sci Res Ctr, Tehran 141556451, Iran
[3] Univ Tehran Med Sci, Dept Pharmaceut, Fac Pharm, Tehran 141556451, Iran
基金
美国国家科学基金会;
关键词
Granisetron; HPLC; Stability indicating; Forced degradation; TANDEM MASS-SPECTROMETRY; HUMAN PLASMA; LIQUID-CHROMATOGRAPHY; FLUORESCENCE;
D O I
10.1002/jccs.201190004
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
The aim of this study was to study the stress degradation of granisetron and analysis of the drug in the presence of its degradation products. Forced degradation studies were conducted on bulk sample using acidic, alkaline, oxidative, heat and photolytic conditions. Granisetron was relatively unstable under acidic, alkaline and oxidative conditions. Separation of granisetron and degradation products was achieved using a Nova-Pak C(8) column and acetonitrile-KH(2)PO(4) 25 mM (75:25, v/v) as mobile phase with UV detection at 305 nm. The method was linear over the range of 0.2-15 mu g/mL granisetron (r(2) > 0.999). The within-day and between-day precision values were also in the range of 0.5-4%. The proposed method was successfully applied for quantitative determination of granisetron in tablets and in vitro dissolution studies.
引用
收藏
页码:443 / 449
页数:7
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