HPTLC Method Development and Validation: Strategy to Minimize Methodological Failures

HPTLC方法開發和驗證：減少方法失敗的策略

Patel Rashmin ； Patel Mrunali ； Dubey Nitin ； Dubey Nidhi ； Patel Bharat

《藥物食品分析》 20卷4期 (2012/12) Pp. 794-804+982

https://doi.org/10.6227/jfda.2012200408

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。

關鍵字

HPTLC ； 方法開發 ； 方法驗證

並列摘要

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.

並列關鍵字

HPTLC ； Method development ； Method validation

參考文獻

Patel, R. B., Patel, M. R., Bhatt, K. K. and Patel, B. G. 2011. Development and validation of HPTLC method for estimation of carbamazepine in formulations and its in vitro release study. Chrom. Res. Int. 2011: 684369. doi:10.4061/2011/684369.

Patel, R. B., Patel, M. R., Bhatt, K. K. and Patel, B. G. 2010. Development and validation of on HPTLC method for determination of olanzapine in Formulations. J. AOAC Int. 93: 811 - 819.

Patel, R. B., Patel, M. R. and Patel, B. G. 2011. Experimental aspects and implementation of HPTLC. In “High performance thin layer chromatography (HPTLC)”. pp. 41-54. Srivastava, M. M. ed. Springer Berlin Heidelberg, New York, USA.

Sherma, J. 2008. Modern thin layer chromatography. J. AOAC Int. 91: 1142 - 1144.

Patel, M. R., Patel, R. B., Parikh, J. R. and Patel, B. G. 2010. HPTLC method for estimation of tazarotene in topical gel formulations and in vitro study. Anal. Methods 2: 275 - 281.