Validation of the Stability-Indicating HPLC Method for the Major Flavonoids in Spray- Dryed Leaf Extract of Aleurites moluccana L. Willd

Author(s): Talita Gesser Cesca, Luciana Catia Block, Marina Silva Machado, Carolina Wittkowski, Christiane Meyre-Silva, Marcia Maria de Souza, Nara Lins Meira Quintao, Ruth Meri Lucinda Silva, Denise Brentan da Silva, Eduardo Fernandes, Leandro de Santis Ferreira, Norberto Peporine Lopes, Valdir Cechinel Filho, Tania Mari Belle Bresolin

Journal Name: Current Pharmaceutical Analysis

Volume 8 , Issue 4 , 2012


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Abstract:

The HPLC-UV method previously developed for the analysis of the flavonoid 2”-O-rhamnosylswertisin (I), an active compound of dried leaf extracts of Aleurites moluccana L. Willd, was fully validated with the inclusion of another flavonoid, swertisin (II). The stability-indicating capability of the method was established by analyzing forced degradation extract samples (acid, alkali, neutral, oxidative and photolytic condition) in which the spectral purity of the markers was ascertained together with the separation of degradation products from the markers. The method proved be linear over a range of 5.89-117.8 and 1.38-27.68 μg.mL-1 for I and II, respectively. The recovery for I and II was 100.3 and 102.8%, respectively, at a level of 100%. A relative standard deviation (RSD%) < 1.0% (intra-day) and < 3.5% (inter-days) for area, and less than 0.5% for retention time indicated that the precision of the method is acceptable. Validation parameters such as selectivity and robustness were also determined. In addition, during the course of LC-MSn analysis three other flavonoids were discovered in the A. moluccana extract and their tentative structures identified.

Keywords: Aleurites moluccana, Analytical Validation, Flavonoids, Leaf Standardized Extract, HPLC-UV, LC-MS, Stability- Indicating Method, Spray Drying

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Article Details

VOLUME: 8
ISSUE: 4
Year: 2012
Published on: 02 October, 2012
Page: [349 - 359]
Pages: 11
DOI: 10.2174/157341212803341726
Price: $65

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