Planta Med 2018; 84(06/07): 465-474
DOI: 10.1055/a-0575-4425
Natural Product Chemistry and Analytical Studies
Original Papers
Georg Thieme Verlag KG Stuttgart · New York

Comprehensive HPTLC Fingerprinting for Quality Control of an Herbal Drug – The Case of Angelica gigas Root

Débora Arruda Frommenwiler
1   CAMAG Laboratory, Muttenz, Switzerland
2   Unit of Pharmacology, Pharmacognosy and Therapeutics, Faculty of Pharmacy and Food Sciences, University of Barcelona, Spain
,
Jonghwan Kim
3   National Institute of Food and Drug Safety Evaluation, Chungcheongbuk-do, Republic of Korea
,
Chang-Soo Yook
4   Oriental Pharmaceutical Science Department, Kyunghee University, Seoul, Republic of Korea
,
Thi Thu Trang Tran
5   National Institute of Drug Quality Control, Ha Noi, Vietnam
,
Salvador Cañigueral
2   Unit of Pharmacology, Pharmacognosy and Therapeutics, Faculty of Pharmacy and Food Sciences, University of Barcelona, Spain
,
Eike Reich
1   CAMAG Laboratory, Muttenz, Switzerland
› Author Affiliations
Further Information

Publication History

received 29 May 2017
revised 22 January 2018

accepted 01 February 2018

Publication Date:
28 February 2018 (online)

Abstract

The quality of herbal drugs is usually controlled using several tests recommended in a monograph. HPTLC is the method of choice for identification in many pharmacopoeias. If combined with a suitable reference material for comparison, HPTLC can provide information beyond identification and thus may simplify quality control. This paper describes, as a proof of concept, how HPTLC can be applied to define specifications for an herbal reference material and to control the quality of an herbal drug according to these specifications. Based on multiple batches of cultivated Angelica gigas root, a specific HPTLC method for identification was optimized. This method can distinguish 27 related species. It also can detect the presence of mixtures of A. gigas with two other Angelica species traded as “Dang gui” and is suitable as well for quantitative assessment of samples in a test for minimum content of the sum of decursin and decursinol angelate. The new concept of “comprehensive HPTLC fingerprinting” is proposed: HPTLC fingerprints (images), which are used for identification, are converted into peak profiles and the intensities of selected zones are quantitatively compared to those of the corresponding zones of the reference material. Following a collaborative trial involving three laboratories in three countries, the method was applied to check the quality of further candidates for establishing an appropriate reference material. In conclusion, this case demonstrates that a single HPTLC analysis can provide information about identity, purity, and minimum content of markers of an herbal drug.

Supporting Information

 
  • References

  • 1 United Stated Food & Drug Administration (FDA). CFR – Code of Federal Regulations Title 21. Sec. 111.75 What must you do to determine whether specifications are met? Available at. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=111.75 Accessed October 15, 2017
  • 2 European Agency for the Evaluation of Medicinal Products (EMEA). Guidelines on quality of herbal medicinal products/traditional medicinal products, EMA/HMPC/201116/2005 Rev. 2. London: European Medicines Agency; 2011
  • 3 World Health Organization (WHO). Quality control methods for herbal materials (Updated edition of quality control methods for medicinal plant materials, 1998). Geneva: WHO Library Cataloguing-in-Publication Data; 2011
  • 4 World Health Organization (WHO). Review of world pharmacopoeia, working document QAS/12.512/Rev.1. International Meeting of World Pharmacopoeias. Geneva: World Health Organization; 2012
  • 5 Upton RRH. Traditional herbal Medicine, Pharmacognosy, and pharmacopoeial Standards: a Discussion at the Crossroads. In: Mukherjee PK. ed. Evidence-based Validation of herbal Medicine. Amsterdam: Elsevier; 2015: 45-65
  • 6 Reich E, Schibli A. Validation of high-performance thin-layer chromatographic methods for the identification of botanicals in a cGMP environment. J AOAC Int 2008; 91: 13-20
  • 7 Forum for the Harmonization of Herbal Medicines. Available at. http://www.fhhm.net/ Accessed September 22, 2016
  • 8 Wu ZY, Raven PH. Moss Flora of China, Vol 8. St. Louis: Missouri Botanical Garden Science Press; 2005: 158
  • 9 Shan RH. Umbelliferae. In: Sheh ML, Shan RH. eds. Flora reipublicae popularis sinicae . Beijing: Academia Sinica; 1992: 13-62
  • 10 Lao SC, Li SP, Kan KKW, Li P, Wan JB, Wang YT, Dong TTX, Tsim KWK. Identification and quantification of 13 components in Angelica sinensis (Danggui) by gas chromatography – mass spectrometry coupled with pressurized liquid extraction. Anal Chim Acta 2004; 526: 131-137
  • 11 Jeong SY, Kim HM, Lee KH, Kim KY, Huang DS, Kim JH, Seong RS. Quantitative analysis of marker compounds in Angelica gigas, Angelica sinensis and Angelica acutiloba by HPLC/DAD. Chem Pharm Bull 2015; 63: 504-511
  • 12 Upton R, Graff A, Swisher D. Dang gui Root. In: Upton R. ed. American herbal Pharmacopoeia and therapeurical Compendium. Scotts Valley: AHP; 2003: 1-41
  • 13 Hook ILI. Danggui to Angelica sinensis root: are potential benefits to European women lost in translation? A review. J Ethnopharmacol 2014; 152: 1-13
  • 14 European Pharmacopoeia, 9th Edition. Chapter 2.8.25: High-performance thin-layer Chromatography of herbal Drugs and herbal Preparations. Strasbourg: European Directorate for the Quality of Medicines and Healthcare (EDQM); 2017: 295-296
  • 15 The United States Pharmacopoeia 40–NF 35. Chapter 203: High-performance thin-layer Chromatography Procedure for Identification of Articles of botanical Origin. Rockville: Pharmacopoeial Convention; 2017: 258-260
  • 16 The United States Pharmacopeia 40–NF 35. Chapter 1064: Identification of Articles of botanical Origin by high-performance thin-layer Chromatography Procedure. Rockville: Pharmacopeial Convention; 2017: 1187-1197
  • 17 Chinese Pharmacopoeia Commission. TLC Atlas of Chinese crude Drugs in Pharmacopoeia of the Peopleʼs Republic of China. 1st edition. Beijing: Peopleʼs Medical Publishing House; 2008
  • 18 Indian Council of Medical Research. Quality Standards of Indian medicinal Plants, 14 volumes. New Delhi: Aravali Printers & Publishers; 2016
  • 19 United States Pharmacopeial Convention. United States Pharmacopoeia dietary Supplement Compendium. Rockville: Pharmacopoeial Convention; 2015
  • 20 United States Pharmacopeial Convention. Herbal medicines compendium. Available at. https://hmc.usp.org/ Accessed November 01, 2017
  • 21 American Herbal Pharmacopoeia and therapeurical Compendium, 35 volumes. Scotts Valley: American Herbal Pharmacopoeia; 2017
  • 22 Hong Kong Chinese Materia Medica Standards, 8 volumes. Available at. http://www.cmd.gov.hk/html/eng/hkcmms/cmmlist.html Accessed August 10, 2016
  • 23 Bauer R, Melchart D, Xiao PG, Staudinger A, Wagner H. Chromatographic Fingerprint Analysis of herbal Medicines. Kötzting, Wien, New York: Springer; 2011
  • 24 Reich E, Frommenwiler DA, Maire-Widmer V. High-performance thin-layer Chromatography for the Identification of botanical Materials and the Detection of Adulteration. In: Reynertson KA, Mahmood K. eds. Botanicals Methods and Techniques for Quality & Authenticity. Boca Raton: CRC Press; 2015: 241-259
  • 25 Spangenberg B, Poole CF, Weins C. Qualtitative thin-layer Chromatography. A practical Survey. Heidelberg: Springer Science & Business Media; 2011: 245-246
  • 26 The Korean Pharmacopoeia, 10th Edition. Monographs for Angelica dahurica Root, Angelica gigas Root and Cnidium officinale Rhizome. Osong: Ministry of Food and Drug Safety; 2012: 1258-1261 1279-1280
  • 27 European Pharmacopoeia, 9th Edition. Monographs for Angelica archangelica Root (1857), Angelica dahurica Root (2556), Angelica pubescens Root (2557), Angelica sinensis Root (2558) and Levisticum officinale Root (1233). Strasbourg: European Directorate for the Quality of Medicine and Healthcare (EDQM); 2017: 1242-1248 1420-1421
  • 28 Chinese Pharmacopoeia Commission. TLC Atlas of Chinese crude Drug in Pharmacopoeia of the Peopleʼs Republic of China. TLC Identification of Radix Angelicae dahuricae, Radix Angelicae pubescentis, Radix Angelicae sinensis, Rhizoma Chuanxiong and Rhizoma et Radix Ligustici. Beijing: Peopleʼs Medical Publishing House; 2008: 172-175 244 259
  • 29 Pharmacopoeia of the Peopleʼs Republic of China. Monographs for Angelicae dahuricae Radix, Angelicae pubescentis Radix, Angelicae sinensis Radix, Chuangxiong Rhizoma and Ligustici Rhizoma et Radix. Beijing: Chinese Pharmacopoeia Commission; 2010: 35-38 105-106 249-250
  • 30 Hong Kong Chinese Materia Medica Standards. Monographs for Radix Angelicae pubescentis, Radix Angelicae sinesis, Ligustici Rhizoma et Radix. Hong Kong: Chinese Medicine Division, Department of Health, The Government of the Hing Kong Special Admnistrative Region; Available at http://www.cmd.gov.hk/html/eng/hkcmms/cmmlist.html Accessed August 10 2016. Accessed August 10, 2016
  • 31 British Pharmacopoeia. Monographs for Angelica Root (Angelica archangelica) and Angelica sinensis Root for Use in THM. London: Medicineas and Healthcare Products Regulatory Agency; 2009: 3331-3334
  • 32 Bauer R, Melchart D, Xiao PG, Staudinger A, Wagner H. Monographs for Radix Angelicae pubescentis (Duhuo), Radix Angelicae sinensis (Danggui), Radix Angelicae dahuricae (Baizhi) and Radix Ligustici chuanxiong (Chuanxiong). In: Bauer R, Melchart D, Xiao PG, Staudinger A, Wagner H. eds. Chromatographic Fingerprint Analysis of herbal Medicines. Kötzting, Wien, New York: Springer; 2011: 99-111 161-190