Validation of Standardized High-Performance Thin-Layer Chromatographic Methods for Quality Control and Stability Testing of Herbals
Abstract
In herbal medicinal products the entire herbal drug or an herbal drug preparation is regarded as the active pharmaceutical ingredient, regardless of whether constituents with defined therapeutic activity are known. In quality control and stability testing of herbal medicinal products, fingerprint chromatograms are used as powerful tools to evaluate and compare the composition of compounds in such products. To fulfill the International Conference on Harmonization and Good Manufacturing Practice-based regulatory requirements in pharmaceutical quality control, chromatographic fingerprint analysis needs to be validated. Based on a standardized methodology, this paper provides a comprehensive concept for evaluating validation parameters for planar chromatographic fingerprinting by considering the stationary phase, sample application, developing solvent, chromatogram development, plate labeling, derivatization, documentation, and chromatographic equipment. Validation parameters addressed include stability of the analyte, selectivity, robustness testing, and method reproducibility.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The HPTLC technique is a convenient and effective approach for qualitative and quantitative analysis and standardization of medicinal materials.
“However, the HPTLC technique stands out as a convenient and effective approach for qualitative and quantitative analysis, as well as standardization of medicinal materials.”
From Phytoecdysteroids: Quantification in Selected Plant Species and Evaluation of Some Effects on Gastric Smooth Muscles (2024) · cites this paper as [51]
Cited by
Sorted by citations
Quality Control of Herbal Medicines: From Traditional Techniques to State-of-the-art Approaches
Klein‐Júnior, L. C., de Souza, M. R., Viaene, J., Bresolin, T. M. B., de Gasper, A. L., Henriques, A. T., & Heyden, Y. V. (2021) · Planta Medica · doi:10.1055/a-1529-8339 · Cited by 121 · see citing works
“Consequently, it is desirable to use a combination of independent methods covering different groups of constituents to achieve the required selectivity level [20, 75].”
BackgroundMethodInfluentialQuality assessment of South African herbal medicines by means of HPLC fingerprinting
Springfield, E. P., Eagles, P. K. F., & Scott, G. (2005) · Journal of Ethnopharmacology · doi:10.1016/j.jep.2005.03.012 · Cited by 110 · see citing works
Development of Impurity Profiling Methods Using Modern Analytical Techniques
Ramachandra, B. (2016) · Critical Reviews in Analytical Chemistry · doi:10.1080/10408347.2016.1169913 · Cited by 90 · see citing works
“HPTLC is one of the most widely applied methods for analysis in pharmaceutical industries, forensic chemistry, clinical chemistry, biochemistry, food and drug analysis, cosmetology, environmental analysis and other areas (Rakesh et al., 2013; Koll et al., 2003; Sherma, 2010).”
MethodReich, E., Schibli, A., & DeBatt, A. (2008) · Journal of AOAC International · doi:10.1093/jaoac/91.1.13 · Cited by 88 · see citing works
Self-citationDevelopment of the chromatographic fingerprint of herbal preparations Shuang–Huang–Lian oral liquid
Cao, Y., Wang, L., Yu, X., et al. (2006) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2006.01.060 · Cited by 82 · see citing works
Xie, Y., Jiang, Z., Zhou, H., et al. (2006) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2006.07.008 · Cited by 75 · see citing works
HPTLC Methods for Identification of Green Tea and Green Tea Extract
Reich, E., Schibli, A., Widmer, V., et al. (2006) · Journal of Liquid Chromatography & Related Technologies · doi:10.1080/15512160600760293 · Cited by 68 · see citing works
“The method for identification of green tea based on its polyphenol profile was validated according to the concept published by Koll et al.[21] using a botanically authenticated sample of green tea as BRM.”
MethodSelf-citationCurrent Trends in Herbal Medicines
Rao, A. L., Dathi, S., & Vishnu, S. (2010) · Journal of Pharmacy Research · Cited by 67 · see citing works
HPTLC Method Development and Validation: Strategy to Minimize Methodological Failures
Patel, R. B., Patel, M. R., Dubey, N., et al. (2012) · Journal of Food and Drug Analysis · doi:10.6227/jfda.2012200408 · Cited by 65 · see citing works
'HPTLC' an important tool in standardization of herbal medical product: A review
Shivatare, R. S., Nagore, D. H., & Nipanikar, S. U. (2013) · Cited by 47 · see citing works
Biringanine, G., Chiarelli, M. P., Faes, M., & Duez, P. (2005) · Talanta · doi:10.1016/j.talanta.2005.10.007 · Cited by 43 · see citing works
Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications
Uddin, M. S., Mamun, A. A., Kabir, M. A., et al. (2017) · Journal of Advances in Medical and Pharmaceutical Sciences · doi:10.9734/jamps/2017/33924 · Cited by 40 · see citing works
Experimental Aspects and Implementation of HPTLC
Patel, R. B., Patel, M. R., & Batel, B. G. (2010) · Springer eBooks · doi:10.1007/978-3-642-14025-9_3 · Cited by 34 · see citing works
“3) (Koll et al. 2003; Reich et al. 2008; Patel et al. 2009; Patel et al. 2010).”
Plant Analysis 2008 – Planar Chromatography
Reich, E., & Widmer, V. (2008) · Planta Medica · doi:10.1055/s-0028-1088389 · Cited by 34 · see citing works
“It is also a concept, including a scientific basis [5], standardized methodology [6], and validated methods [7].”
Self-citationCorrelation between Chromatographic Fingerprint and Antioxidant Activity ofTurnera diffusa(Damiana)
Garza-Juárez, A. D. J., Salazar-Cavazos, M. D. L. L., Salazar‐Aranda, R., et al. (2011) · Planta Medica · doi:10.1055/s-0030-1250684 · Cited by 33 · see citing works
Schibli, A., & Reich, E. (2005) · Journal of Planar Chromatography – Modern TLC · doi:10.1556/jpc.18.2005.1.6 · Cited by 28 · see citing works
Self-citationSidor, E., Miłek, M., Tomczyk, M., & Dżugan, M. (2021) · Antioxidants · doi:10.3390/antiox10050639 · Cited by 23 · see citing works
“During HPTLC separation, polyphenols occur as bands of different intensity, which is crucial for the construction of characteristic fingerprints [26,27].”
BackgroundLiu, H., Liu, H., Li, J., & Wang, Y. (2022) · Critical Reviews in Analytical Chemistry · doi:10.1080/10408347.2022.2124839 · Cited by 20 · see citing works
Srivastava, N. K., Khatoon, S., Rawat, A. K. S., et al. (2009) · Journal of Chromatographic Science · doi:10.1093/chromsci/47.10.936 · Cited by 21 · see citing works
HPTLC Fingerprint in Herbal Drug Formulations
Lalhriatpuii, T. C. (2019) · Springer eBooks · doi:10.1007/978-981-13-7248-3_22 · Cited by 20 · see citing works
HPTLC Method for Determination of 20-Hydroxyecdysone in Sida rhombifolia L. and Dietary Supplements
Jadhav, A. N., Rumalla, C. S., Avula, B., & Khan, I. A. (2007) · Chromatographia · doi:10.1365/s10337-007-0407-3 · Cited by 18 · see citing works
Coran, S. A., Mulas, S., & Mulinacci, N. (2011) · Journal of Chromatography A · doi:10.1016/j.chroma.2011.11.040 · Cited by 17 · see citing works
TLC fingerprinting analysis of the European dog rose
Nowak, R. (2007) · Journal of Planar Chromatography – Modern TLC · doi:10.1556/jpc.20.2007.1.6 · Cited by 16 · see citing works
HPTLC Method Development of Herbal drugs and its Validation: An Overview
Vyas, A., Jain, V. K., Sahu, U., Kumar, N., & Joshi, N. (2023) · Research Journal of Pharmacy and Technology · doi:10.52711/0974-360x.2023.00652 · Cited by 17 · see citing works
Durón, R. R., Almaguer, L. C., Garza-Juárez, A. D. J., et al. (2009) · Acta Chromatographica · doi:10.1556/achrom.21.2009.2.2 · Cited by 14 · see citing works
Gupta, M. M., Srivastava, A., Tripathi, A., et al. (2006) · Journal of Planar Chromatography – Modern TLC · doi:10.1556/jpc.19.2006.4.5 · Cited by 13 · see citing works
Srinivas, P., Anubala, S., Sarma, V., et al. (2007) · Journal of Planar Chromatography – Modern TLC · doi:10.1556/jpc.20.2007.1.13 · Cited by 12 · see citing works
A HPTLC method for chemotaxonomic evaluation of some Curcuma Species and their commercial samples
Srivastava, S. K., Srivastava, M., Mehrotra, S., et al. (2009) · Journal of Scientific & Industrial Research · Cited by 12 · see citing works
Tran, V.-H., Thang, P. N. T., Hien, H. M., et al. (2022) · Plants · doi:10.3390/plants11233397 · Cited by 10 · see citing works
“An important property of HPTLC fingerprint analysis is the large number of samples that can be analyzed in parallel [31].”
BackgroundSanganalmath, P. U., Sujatha, K., Bhargavi, S., et al. (2009) · Journal of Planar Chromatography – Modern TLC · doi:10.1556/jpc.22.2009.1.6 · Cited by 10 · see citing works
Chromatographic Studies on the Tannins of Aerva lanata (L.) Juss. Ex Schultes
Yamuna Devi, M. (2012) · IOSR Journal of Pharmacy (IOSRPHR) · doi:10.9790/3013-02104151 · Cited by 8 · see citing works
Todorova, V., Ivanova, S., Yotov, V., Zaytseva, E., Ardasheva, R., Turiyski, V., Prissadova, N., & Ivanov, K. (2024) · Molecules · doi:10.3390/molecules29215145 · Cited by 7 · see citing works
“Research suggests that 20-”
BackgroundDo, T. K. T., & Reich, E. (2023) · Journal of Planar Chromatography – Modern TLC · doi:10.1007/s00764-023-00265-w · Cited by 7 · see citing works
“Two papers [18, 19] and a textbook [20] addressed this situation by clearly defining HPTLC as a suitable alternative, proposing a concept for validating HPTLC methods for identification of herbal (botanical) materials, and explaining the proper use of HPTLC to analysts in the botanical dietary…”
Self-citationMishra, S., & Aeri, V. (2016) · Pharmaceutical Biology · doi:10.1080/13880209.2016.1238948 · Cited by 7 · see citing works
“The stability of reference standard solutions (500 ng/band) was determined by comparing the peak area in respective chromatograms developed at 0 and 24 h of storage at room temperature (Koll et al. 2003).”
MethodChemometrics Evaluation of the Herbal Drug Andrographis paniculata
Sharma, S. N., Jha, Z., & Sharma, D. K. (2011) · Natural Product Communications · doi:10.1177/1934578x1100601235 · Cited by 7 · see citing works
Garza-Juárez, A. D. J., de Torres, N. H. W., Ramírez-Durón, R., et al. (2009) · Acta Chromatographica · doi:10.1556/achrom.21.2009.2.3 · Cited by 6 · see citing works
Quantitative HPTLC analysis of phenylpropanoids inRhodiolaspecies
Rumalla, C. S., Avula, B., Ali, Z., et al. (2011) · Journal of Planar Chromatography – Modern TLC · doi:10.1556/jpc.24.2011.2.6 · Cited by 6 · see citing works
Recent Advances in Herbal Drug Technology
Dighe, S. B., Kangude, D., Kangune, D. B., et al. (2023) · Asian Journal of Research in Pharmaceutical Sciences · doi:10.52711/2231-5659.2023.00052 · Cited by 5 · see citing works
Minh, H. H., Thuy, T. H. N., & Viet, H. T. (2023) · Heliyon · doi:10.1016/j.heliyon.2023.e15008 · Cited by 4 · see citing works
“Validation of TLC method Method validation was performed according to AOAC and ICH guideline [8,9].”
MethodIsolation and Characterization of Leaf Extract of Derris trifoliate
Thangaraj, M., & Salai, R. G. (2014) · Cited by 4 · see citing works
de Souza, M. R., Limberger, R. P., & Henriques, A. T. (2021) · Journal of Liquid Chromatography & Related Technologies · doi:10.1080/10826076.2022.2086566 · Cited by 3 · see citing works
“To that end, the proposed method must be challenged, using a set of structurally similar analytes, in addition to samples with different characteristics.([13,31])”
MethodZehra, S., Saeed, M. A., Zaman, M., Hassan, S., & Fazal‐ur‐Rehman (2024) · Discover Applied Sciences · doi:10.1007/s42452-024-05757-w · Cited by 3 · see citing works
Bhope, S. G., Kuber, V. V., Ghosh, V. K., et al. (2011) · Journal of Liquid Chromatography & Related Technologies · doi:10.1080/10826076.2010.534723 · Cited by 3 · see citing works
DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF OLEANOLIC ACID IN ARISTAKA
Khanpara, K., Renuka, R., & Shukla, V. J. (2014) · International Research Journal of Pharmacy · doi:10.7897/2230-8407.050468 · Cited by 3 · see citing works
Kumar, K. S., Pushpendra, P., Holla, B., et al. (2015) · AYU (An International Quarterly Journal of Research in Ayurveda) · doi:10.4103/0974-8520.182745 · Cited by 3 · see citing works
“With the help of modern analytical techniques, such as spectrophotometry, HPLC, high performance TLC (HPTLC) and by employing proper guidelines it is possible to generate a sound stability data of herbal products and predict their shelf life, which will help in improving global acceptability of herbal products.[4]”
MethodChowdhury, M. N. S., Dalal, S. N., Islam, M. A., et al. (2024) · American Journal of Analytical Chemistry · doi:10.4236/ajac.2024.155010 · Cited by 2 · see citing works
Utility of Thin-Layer Chromatography in the Assessment of the Quality of Botanicals
Galal, A. M., Avula, B., & Khan, I. A. (2014) · Elsevier eBooks · doi:10.1016/b978-0-12-417223-4.00018-2 · Cited by 2 · see citing works
Medicines and Dietary Supplements Produced from Plants
Widmer, V., Reich, E., & Ankli, A. (2008) · Chromatographic science/Chromatographic science series · doi:10.1201/9781420046786.ch3 · Cited by 2 · see citing works
Self-citationРАЗРАБОТКА И ВАЛИДАЦИЯ МЕТОДИКИ ИДЕНТИФИКАЦИИ КАЛЕНДУЛОЗИДОВ В НАСТОЙКЕ КАЛЕНДУЛЫ. СООБЩЕНИЕ 2.
(Khokhlova), Е. (. А. (. Х., (Zdorik), А. (. А. (. З., (Georgijanc), В. (. А. (. Г., et al. (2015) · chemistry of plant raw material · doi:10.14258/jcprm.201502398 · Cited by 2 · see citing works
Sikdar, K. Y. K., Islam, M. K., Sostaric, T., et al. (2024) · Applied Sciences · doi:10.3390/app142311064 · Cited by 1 · see citing works
Sharma, A., Kaur, S., Rani, A., et al. (2025) · Elsevier eBooks · doi:10.1016/b978-0-443-33710-9.00015-7 · Cited by 1 · see citing works
Accelerated Stability Study of Khamirae Gaozaban Sada
Rani, S., Zaman, R., & Shamsi, S. (2013) · Cited by 1 · see citing works
Sankpal, S. D., Mullani, A. K., Mohite, S. K., et al. (2014) · International Journal of Bioassays · doi:10.21746/ijbio.2014.09.0010 · Cited by 1 · see citing works
Critical Factor That Governs a Successful TLC/ HPTLC Analysis of Herbal Medicinal Products (HMPS).
Kasar, R., Gogia, A., Shah, K., et al. (2013) · Cited by 1 · see citing works
ISOLATION AND CHARACTERIZATION OF LEAF EXTRACT OF DERRIS TRIFOLIATA
Stanley, R. S. A. D. S. A. (2015) · International Journal of Pharma and Bio Sciences
THIN-LAYER CHROMATOGRAPHY | Method Development ☆
Reich, E., & Tiên, T. K. (2017) · Elsevier eBooks · doi:10.1016/b978-0-12-409547-2.14313-6
Self-citationAli, H., Alvi, A., Nawab, A., et al. (2019) · Journal of pharmacy and pharmaceutical sciences
A PROSPECTIVE REVIEW ON THE ANALYTICAL METHODS OF SARTAN GROUP OF DRUGS
(2021) · International Journal of Biology Pharmacy and Allied Sciences · doi:10.31032/ijbpas/2021/10.12.2046
Current Awareness in Phytochemical Analysis
(2004) · Phytochemical Analysis · doi:10.1002/pca.747
THIN-LAYER CHROMATOGRAPHY | Method Development
Reich, E., & Blatter, A. (2005) · Elsevier eBooks · doi:10.1016/b0-12-369397-7/00623-3
Self-citationFlade, J., Kelber, O., Nieber, K., et al. (2025) · Planta Medica · doi:10.1055/a-2727-1619
“…perforatum , herba (DER: 0.5 – 0.9, Schoenenberger, lot number 122 A) was tested in the Ames test with the same procedure as for the dry extracts (results shown in Tables 4S to Table 6S , Supporting Infor-▶ above-mentioned data, which were ascertained within the framework of the “…”
Influential
- Authors
- Koll, K., Reich, E., Blatter, A., & Veit, M.
- Affiliations
- Forschungsvereinigung der Arzneimittel-Hersteller e.V. (FAH), Kranzweiherweg 10, 53489 Sinzig, Germany
- CAMAG-Laboratory, Sonnenmattstrasse 11, CH-4132 Muttenz, Switzerland
- Laboratoire Interdisciplinaire des Énergies de Demain (FR)
- ORCID
- Reich, Eike
- Venue
- Journal of AOAC International
- Publisher
- Oxford University Press (OUP)
- Published
- 2003-09-01
- Volume
- 86
- Issue
- 5
- Pages
- 909-915
- ISSN
- 1060-3271 (ISSN-L)
- 1944-7922
- OpenAlex
- W1516782033
- Cited by
- 65
- References
- 0
- Citations by year
- 2025: 2 · 2024: 4 · 2023: 5 · 2022: 2 · 2021: 4 · 2019: 2 · 2017: 2 · 2016: 2 · 2015: 3 · 2014: 4 · 2013: 4 · 2012: 2
- FWCI
- 3.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Journal of AOAC International (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Physical Sciences › Chemistry › Analytical Chemistry › Chromatography in Natural Products
- Health Sciences › Medicine › Complementary and alternative medicine › Traditional Chinese Medicine Analysis
- Keywords
- herbal medicinal products, thin-layer chromatography, chromatographic fingerprint, method validation, quality control, stability testing, ICH guidelines, robustness testing, selectivity, reproducibility, stationary phase, derivatization
- MeSH terms
- Chromatography, High Pressure Liquid, Drug Stability, Pharmaceutical Preparations, Quality Control, Sensitivity and Specificity, Reproducibility of Results, Plant Preparations
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
