作者
Kapendra Sahu, C Karthikeyan, NS Hari Narayana Moorthy, Piyush Trivedi
发表日期
2011/10/15
期刊
Journal of liquid chromatography & related technologies
卷号
34
期号
17
页码范围
1870-1884
出版商
Taylor & Francis Group
简介
A novel stability-indicating ultra-performance liquid chromatographic (UPLC) assay method was developed and validated for prasugrel and its degradation products. The UPLC separation was performed on Acquity® UPLC BEH C18 column (1.7 µm, 2.1 mm × 150 mm) using isocratic mode (acetonitrile:water, 80:20 v/v) at flow rate of 0.1 mL/min and the high performance liquid chromatography (HPLC) separation was achieved on Phenomenex® C8 column using isocratic mode (acetonitrile:10 mM ammonium acetate, 85:15 v/v) at flow rate of 0.9 mL/min. Prasugrel was found to degrade significantly in hydrolytic (acid, alkali, and neutral), and oxidative stress conditions and was stable in thermal and photolytic stress conditions. The RSD (%) values calculated for the AUC of UPLC and HPLC are 0.0039 and 0.0015, respectively. The UPLC and HPLC linearity of the proposed method were investigated in the range of …
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