Quality control, development and validation of HPLC analytical methodology for harpagoside content on dry extracts of Harpagophytum procumbens Burch DC

Authors

DOI:

https://doi.org/10.18378/rebes.v14i1.9868

Keywords:

Devil's claw, Herbal, Liquid chromatography

Abstract

Harpagophytum procumbens is found in Namibia, Botswana and Kalahari. It belongs to the Pedaliaceae family and is known as Devil's Claw. Its roots contain harpagoside and harpagid iridoids, triterpenes and flavonoids and are used as anti-inflammatory and analgesic. The objective was to evaluate the physicochemical and microbiological quality, to develop HPLC and TLC methodology of the dry extract of the plant. Two samples of the dry extract of H. procumbens from different suppliers were used, sample 15-18% (A) and 15% (B) of Harpagoside. Determination of aspect, loss by drying, heavy metals, apparent density, total ash and microbiological analyses were performed according to official compendia. The identification was performed by CCDA with mobile phase composed of ethyl acetate:methanol:water (77:15:8), revealed with sulfuric vanillin. The assay was performed by HPLC. The physicochemical analyses highlighted the appearance of yellowish to brown powder, loss by drying of 2.6-4.17%, apparent density of 0.347-0.635 g/mL and total ash of 1.05-3.79%. Growth within the limits, absence of pathogens and coliforms were observed. The samples under analysis presented violet band with the same retention factor (0.65), referring to harpagoside. The method was specific, precise, accurate (RSD <5%), linear (r=>0.9939) and robust, being suitable for the marker. The assay provided 15.94 ± 0.49 % (A) and 15.27 ± 1.34 % (B). The samples analyzed were in accordance with the specifications of each test performed. It was possible to affirm that the extracts of Harpagophytum procumbens used in the trials and marketed in Brazil presented results that prove their quality, safety and efficacy.

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Author Biographies

Diego Igor Alves Fernandes de Araújo, Universidade Federal da `Paraíba, João Pessoa, Paraíba

Doutorado em Produtos Naturais e Sintéticos Bioativos pela Universidade Federal da Paraíba, João Pessoa, Paraíba. Docente do curso de Farmácia do Centro Universitário de Patos - UNIFIP

Ericka Maria de Farias Moreira, Faculdade São Francisco da Paraíba, Cajazeiras, Paraíba

Graduanda em Farmácia pela Faculdade São Francisco da Paraíba, Cajazeiras, Paraíba

Petronio da Silva Ramos, Faculdade Nova Esperança, João Pessoa, Paraíba

Graduado em Farmácia pela Faculdade Nova Esperança - FACENE, João Pessoa, Paraíba

Rubens Leite Ramalho, Faculdade Nova Esperança, João Pessoa, Paraíba

Graduado em Farmácia pela Faculdade Nova Esperança - FACENE, João Pessoa, Paraíba

Lívia Paloma Gomes Leite, Faculdade São Francisco da Paraíba, Cajazeiras, Paraíba

Graduada em Farmácia pela Faculdade São Francisco da Paraíba, Cajazeiras, Paraíba

Umberto Pereira Souza Júnior, Universidade Federal Rural de Pernambuco, Recife, Pernambuco

Doutor em Desenvolvimento e Inovação Tecnológica em Medicamentos pela Universidade Federal Rural de Pernambuco, Recife, Pernambuco

References

ALEGBELEYE, O. O., SINGLETON, I., & SANT'ANA, A. S. (2018). Sources and contamination routes of microbial pathogens to fresh produce during field cultivation: A review. Food microbiology, 73, 177–208. https://doi.org/10.1016/j.fm.2018.01.003

ARJOMANDI, M.; SHIRKHANLOO, H. A review: analytical methods for heavy metals determination in environment and human samples. Analytical Methods in Environmental Chemistry Journal, v. 2, n. 03, p. 97-126, 2019. DOI: https://doi.org/10.24200/amecj.v2.i03.73

BALEKUNDRI, A., MANNUR, V. Quality control of the traditional herbs and herbal products: a review. Futur J Pharm Sci, v. 6, n. 67, 2020. DOI: https://doi.org/10.1186/s43094-020-00091-5

BARNI, S. T.; CECHINEL FILHO, V.; COUTO, A. G. Caracterização química e tecnológica das folhas, caules e planta inteira da Ipomoea pes-caprae (L.) R. Br., Convolvulaceae, como matéria-prima farmacêutica. Revista Brasileira de Farmacognosia, v. 19, p. 865-870, 2009. DOI: https://doi.org/10.1590/S0102-695X2009000600012

BRASIL. Agência Nacional de Vigilância Sanitária. Farmacopeia Brasileira, 6 ed., vol. 1. Brasília-DF, 2019a.

BRASIL. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada nº 166, 24 de julho de 2017. Guia para validação de métodos analíticos, Brasília-DF, 2017.

BRASIL. Ministério da Saúde. Resolução da Diretoria Colegiada nº 26, de 13 de maio de 2014. Dispõe sobre o registro de medicamentos fitoterápicos o registro e a notificação de produtos tradicionais fitoterápicos. Brasília-DF, 2014.

BRENDLER T. From Bush Medicine to Modern Phytopharmaceutical: A Bibliographic Review of Devil’s Claw (Harpagophytum spp.). Pharmaceuticals, v. 14, n. 8, p. 726, 2021. DOI:https://doi.org/10.3390/ph14080726

DAO, H.; LAKHANI, P.; POLICE, A.; KALLAKUNTA, V.; AJJARAPU, S. S.; WU, K.; PONKSHE, P.; REPKA, M. A.; MURTHY, N. Microbial Stability of Pharmaceutical and Cosmetic Products. AAPS PharmSciTech, v. 19, p. 60–78, 2018. DOI: 10.1208/s12249-017-0875-1.

DIUZHEVA, A., CARRADORI, S., ANDRUCH, V., LOCATELLI, M., DE LUCA, E., TIECCO, M., GERMANI, R., MENGHINI, L., NOCENTINI, A., GRATTERI, P., & CAMPESTRE, C. Use of Innovative (Micro)Extraction Techniques to Characterise Harpagophytum procumbens Root and its Commercial Food Supplements. Phytochemical analysis, v. 29, n. 3, p. 233–241, 2018. DOI: https://doi.org/10.1002/pca.2737

GXABA, N., & MANGANYI, M. C. The Fight against Infection and Pain: Devil's Claw (Harpagophytum procumbens) a Rich Source of Anti-Inflammatory Activity: 2011-2022. Molecules, v. 27, n. 11, p. 3637. DOI: https://doi.org/10.3390/molecules27113637

KONDAMUDI, N., TURNER, M. W., MCDOUGAL, O. M. Harpagoside Content in Devil's Claw Extracts. Natural product communications, v. 11, n. 9, p. 1215–1216, 2016.

KRIUKOVA A., LYTKIN D., MARCHENKO M., VLADYMYROVA I. Development of green production technology and research of Harpagophytum procumbens root dry extract. Sci. Pharm. Sci., v. 4, n. 32, p. 43–49, 2021.

LI, Y., SHEN, Y., YAO, C. L.; GUO, D. A. Quality assessment of herbal medicines based on chemical fingerprints combined with chemometrics approach: A review. Journal of Pharmaceutical and Biomedical Analysis, v. 185, p. 113215, 2020. DOI: https://doi.org/10.1016/j.jpba.2020.113215

MENGHINI, L., RECINELLA, L., LEONE, S., CHIAVAROLI, A., CICALA, C., BRUNETTI, L., VLADIMIR-KNEŽEVIĆ, S., ORLANDO, G., & FERRANTE, C. Devil's claw (Harpagophytum procumbens) and chronic inflammatory diseases: A concise overview on preclinical and clinical data. Phytotherapy research, v. 33, n. 9, p. 2152–2162, 2019. DOI: https://doi.org/10.1002/ptr.6395

MUKHERJEE, P. K. Qualitative analysis for evaluation of herbal drugs. Quality Control and Evaluation of Herbal Drugs, p. 79-149, 2019.

NALLURI, B. N.; SUJITHKUMAR, S. Characterization and Estimation of Harpagoside in Dried Root Extract and Oral Powder Formulations of Harpagophytum Procumbens by Validated RP-HPLC-PDA Method. Journal of Drug Delivery and Therapeutics, v. 9, n. 2, p. 38-46, 15 mar. 2019. DOI: https://doi.org/10.22270/jddt.v9i2.2459

RIBEIRO, G. dos S.; CARNEIRO, A. de A.; MARTINS, D. H. N.; SIMEONI, L. A.; SILVEIRA, D.; MAGALHÃES, P. O.; FONSECA-BAZZO, Y. M. Determination of harpagoside in Harpagophytum procumbens DC tablet’s using analytical method by High Performance Liquid Chromatography. Eclética Química, [S. l.], v. 45, n. 1, p. 47–55, 2020. DOI: 10.26850/1678-4618eqj.v45.1.2020.p47-55.

ROCHA, L. P. B. da .; ALVES , J. V. de O.; AGUIAR, I. F. da S. .; SILVA, F. H. da; SILVA, R. L. da; ARRUDA, L. G. de; NASCIMENTO FILHO, E. J. do; BARBOSA, B. V. D. da R. .; AMORIM, L. C. de; SILVA, P. M. da; SILVA, M. V. da. Use of medicinal plants: History and relevance. Research, Society and Development, [S. l.], v. 10, n. 10, p. e44101018282, 2021. DOI: 10.33448/rsd-v10i10.18282.

SINGH, A., SHARMA, A., K. VERMA, R., L. CHOPADE, R., P. PANDIT, P., NAGAR, V., SANKHLA, M. Heavy Metal Contamination of Water and Their Toxic Effect on Living Organisms. IntechOpen, 2022. DOI: 10.5772/intechopen.105075

STRANZINGER, S. et al. Review of sensing technologies for measuring powder density variations during pharmaceutical solid dosage form manufacturing. TrAC Trends in Analytical Chemistry, v. 135, p. 116147, 2021. DOI: https://doi.org/10.1016/j.trac.2020.116147

Published

2024-01-02

How to Cite

Araújo, D. I. A. F. de, Moreira, E. M. de F., Ramos, P. da S., Ramalho, R. L., Leite, L. P. G., & Souza Júnior, U. P. (2024). Quality control, development and validation of HPLC analytical methodology for harpagoside content on dry extracts of Harpagophytum procumbens Burch DC . Revista Brasileira De Educação E Saúde, 14(1), 34–42. https://doi.org/10.18378/rebes.v14i1.9868

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