Validation of High-Performance Thin-Layer Chromatographic Methods for the Identification of Botanicals in a cGMP Environment

Abstract

Current Good Manufacturing Practices (cGMP) for botanicals stipulates the use of appropriate methods for identification of raw materials. Due to natural variability, chemical analysis of plant material is a great challenge and requires special approaches. This paper presents a comprehensive proposal to the process of validating qualitative high-performance thin-layer chromatographic (HPTLC) methods, proving that such methods are suitable for the purpose. The steps of the validation process are discussed and illustrated with examples taken from a project aiming at validation of methods for identification of green tea leaf, ginseng root, eleuthero root, echinacea root, black cohosh rhizome, licorice root, kava root, milk thistle aerial parts, feverfew aerial parts, and ginger root. The appendix of the paper, which includes complete documentation and method write-up for those plants, is available on the J. AOAC Int. Website (<ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.atypon-link.com/AOAC/loi/jaoi">http://www.atypon-link.com/AOAC/loi/jaoi</ext-link>).

Phytochemical fingerprinting to thwart black cohosh adulteration: a 15 Actaea species analysis

“…Hence, it can be a useful tool for species identification of Actaea (Avula et al ., 2007). Recent reports from other groups have described methods for identification of species of Actaea based on TLC or HPTLC techniques (Gafner et al ., 2006; Reich et al ., 2008; Verbitski et al ., 2008). However, since TLC or HPTLC experiments often show lower selectivity and sensitivity than HPLC, the results from TLC analysis are less reliable.…”

Assessing the Quality of Various Preparations of Calendula officinalis using High Performance Thin Layer Chromatography

“…The method was validated by testing results for linearity, accuracy, precision, reproducibility, ruggedness and specificity [24,25]. The linearity of the method was established by calculating the areas of the bands for chlorogenic acid from plates spotted with varying concentrations of standardized Calendula officinalis CO 2 extract.…”

Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

“…Often, more than one chromatographic system must be utilized to comprehensively separate and analyze all the phytochemicals that are present in a complex herbal mixture. Methods used for this purpose include HPLC and UHPLC, GC and TLC [ 76 ]. Spectral methods used for botanical analysis include near infrared and UV spectroscopy and NMR [ 77 ].…”