Determination of azide impurity in sartans using reversed-phase HPLC with UV detection
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- 作者：Maja Gričar ; Samo Andren&scaron ; ek ; samo.andrensek@ki.si" class="auth_mail" title="E-mail the corresponding author
- 关键词：Azide ; HPLC-UV ; Sartans ; Irbesartan ; Candesartan ; Valsartan ; Genotoxic impurity
- 刊名：Journal of Pharmaceutical and Biomedical Analysis
- 出版年：2016
- 出版时间：5 June 2016
- 年：2016
- 卷：125
- 期：Complete
- 页码：27-32
- 全文大小：681 K
文摘
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A gradient external standard HPLC method with UV detection for quantitative analysis of azide in sartans (irbesartan, candesartan, valsartan) was developed and validated.
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The method is robust and direct: no derivatization, preconcentration is needed.
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The linearity range (0.84–101 ppm) and recovery (94.0–103.0%) of azide from samples is in accordance with USP requirements (10 ppm of azide in the sample).