Browse > Article

Development of Analytical Method for Quality Control from New Herbal Medicine(HPL-4)  

Kim, Se-Gun (Department of Agricultural Biology, National Academy of Agricultural Science, Rural Development Administration)
Sharma, Dipak Kumar (Department of Oriental Pharmacy Wonkwang University and BK21plus Program & Department of Smart Life-Care Convergence, Wonkwang University, Graduate School)
Lamichhane, Ramakanta (Department of Oriental Pharmacy Wonkwang University and BK21plus Program & Department of Smart Life-Care Convergence, Wonkwang University, Graduate School)
Lee, Kyung-Hee (Department of Oriental Pharmacy Wonkwang University and BK21plus Program & Department of Smart Life-Care Convergence, Wonkwang University, Graduate School)
Han, Sang-Mi (Department of Agricultural Biology, National Academy of Agricultural Science, Rural Development Administration)
Jung, Hyun-Ju (Department of Oriental Pharmacy Wonkwang University and BK21plus Program & Department of Smart Life-Care Convergence, Wonkwang University, Graduate School)
Publication Information
Korean Journal of Pharmacognosy / v.45, no.4, 2014 , pp. 338-345 More about this Journal
Abstract
HPL-4 is a new herbal formulation developed for the treatment of osteoarthritis. In this study, we took HPL-4 to develop a method for simultaneous determination of nine marker compounds (protocatechuic acid, chlorogenic acid, liriodendrin, nodakenin, ${\beta}$-$\small{D}$-(3-O-sinapoyl)frucofuranosyl-${\alpha}$-$\small{D}$-(6-O-sinapoyl)glucopyranoside, quercitrin, 6-gingerol, decursin and decursinol angelate) present in the formulation. The analytes were separated by UPLC system consisting of diode array detector at 205 nm and RP-amide column, and solvent system of $ACN/0.1%H_3PO_4$. Analytical method was validated to evaluate its linearity, limit of detection (LOD), limit of quantification (LOQ), precision, and accuracy. All standards showed good linearity ($R^2$ >0.99) in the rage of $0.25-400.0{\mu}g/mL$. The LOD and LOQ were within the range of 0.021-0.148 and $0.070-0.448{\mu}g/mL$, respectively. Intra- and inter-day precision was less than RSD 4.0% and the accuracy was range from 92.00-104.81% with RSD<4.2%. The results suggest that the developed UPLC method is precise, accurate and effective, and could be applied for quality control of HPL-4 formulation.
Keywords
Simultaneous analysis of multiple components; Herbal formulation; UPLC-DAD; Method validation;
Citations & Related Records
Times Cited By KSCI : 3  (Citation Analysis)
연도 인용수 순위
1 U. S. Food and Drug Administration. (2008) Veregen (Kunecatechins) ointment, 15%. http://www.fda.gov/cder/foi/label/2006/021902lbl.pdf.
2 권순원 (2012) 천연물신약 연구개발 동향 : 개발연구 중심으로. 44. 생명공학연구정책연구센터. 대전.
3 고경화 (2010) 2010 보건산업백서. 584-585. 한국보건산업진흥원. 청원.
4 Kim, S. J., Jeong, H. J., Moon, P. D., Lee, K. M., Lee, H. B., Jung, H. J., Jung, S. K., Rhee, H. K., Yang, D. C., Hong, S. H. and Kim, H. M. (2005) Anti-inflammatory activity of gumiganghwaltang through the inhibition of nuclear factor-kappa B activation in peritoneal macrophages. Biol. Pharm. Bull. 28: 233-237.   DOI   ScienceOn
5 유한회사 한풍제약 (2013) 관절건강에 도움을 주거나 또는 류마티스 관절염 및 골관절염의 예방, 개선 또는 치료를 위한 조성물. 1-25. 특허등록번호 10-1319866.
6 International conference of harmonization (1997) Q2B: Validationof analytical procedures-methodology. US FDA federal register 62: 27463-27467.
7 Ko, B. S., Kang, E. J. and Kim, H. K. (2000) Isolation of sinapic acid esters from Raphani semen. Kor. J. Pharmacogn. 31: 434-437.
8 식품의약품안전처 (2010) 생약/한약제제의 성분 프로파일 설정 가이드라인. 9-23. 식품의약품안전처. 청원.
9 International conference of harmonization (1995) Q2A: Text on validation of analytical procedures. US FDA Federal Register 60: 11260-11266.
10 Lee, G. W., Kim, A R. and Cho, J. S. (2008) HPLC analysis of organic acids, phenol, and benzopyrene in Wood Winger. Yakhak Hoeji 52: 12-19.
11 Kim, Y., Han, S. H., Jeon, J. Y., Hwang, M. H., Im, Y. J., Lee, S. Y., Chae, S. W. and Kim, M. G. (2013) Validation of LC-MS/MS method for determination of ginsenoside Rg1 in human plasma. Analytical Science Technology 26: 221-227.   DOI
12 Moon, Y. H., Go, J. J. and Park, J. Y. (1999) The anti-inflammatory and analgesic activities of Gumiganghwaltang. Kor. J. Pharmacogn. 30: 18-24.