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| 篇名 | HPTLC Method Development and Validation: Strategy to Minimize Methodological Failures |
|---|---|
| 卷期 | 20:4 |
| 並列篇名 | HPTLC方法開發和驗證：減少方法失敗的策略 |
| 作者 | PATEL RASHMIN 、 PATEL MRUNALI 、 DUBEY NITIN 、 DUBEY NIDHI 、 PATEL BHARAT |
| 頁次 | 794-804 |
| 關鍵字 | HPTLC 、 Method development 、 Method validation 、 方法開發 、 方法驗證 、 MEDLINE 、 Scopus 、 SCIE |
| 出刊日期 | 201212 |
| DOI | 10.6227/jfda.2012200408 |
中文摘要
此篇論文討論以HPTLC (High Performance Thin Layer Chromatography)
為基礎的分析方法開發，及依照最適實驗特性條件驗證評估之訊息，因此
結果可與其他特定目標的層析技術方法比較，表現不佳的方法開發可能因
系統上與科學上分離方法的選擇、固定相和移動相。驗證作法可能因沒有
完全理解或忽視部分指引方針，導致在分析過程的步驟沒有充分考慮到驗
證特性定義描述或規格限制。
英文摘要
This paper provides information regarding HPTLC-based analytical method development and evaluation of validation characteristics
in accordance with best practice. As a result it meets standards comparable with other chromatographic techniques with specific aim to
minimize confusion and methodological failure. The poor performance to the method development may be caused by systematic and
scientific approach for the selection of separation mode, stationary phase and mobile phase not taken into consideration. The poor validation
practice may be caused by validation guidelines which are not fully understood or partially neglected, steps of the analytical procedure are
not fully considered during validation or specification limits defining validation characteristics are not described.
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