title: Development of UPLC Fingerprint with Multi-Component Quantitative Analysis for Quality Consistency Evaluation of Herbal Medicine "Hyangsapyeongwisan".
abstract: Hyangsapyeongwisan (HSPWS), known as traditional herbal medicine, has been used in the treatment of gastric disease. Standardization of HSPWS is a necessary step for the establishment of a consistent biological activity for the production and manufacturing of HSPWS herbal preparations. A simple, sensitive and accurate method using ultra-performance liquid chromatography (UPLC) fingerprinting with a diode array detector (DAD) was developed and validated for systematic quality evaluation of HSPWS. Separation conditions were optimized using a Halo C18 2.7 µm, 4.6 × 100 mm column with a mobile phase of 0.1% phosphoric acid and acetonitrile, and detection wavelengths of 215, 250 and 350 nm. Validation of the analytical method was evaluated by tests of linearity, precision, accuracy and robustness. All calibration curves of components showed good linearity (R(2) > 0.9996). The limit of detection (LOD) and limit of quantification (LOQ) were within the ranges of 0.004-0.134 and 0.012-0.406 µg/mL, respectively. The relative standard deviation (RSD) values of intra- and inter-day testing were within the range of 0.01-3.84%. The result of the recovery test was 96.82-104.62% with an RSD value of 0.14-3.84%. Robustness values of all parameters as well as the stability test of analytical solutions were within the standard limit. It showed that the developed method was simple, specific, sensitive, accurate, precise, reproducible and robust for the quantification of active components of HSPWS. Chromatographic fingerprinting with quantitative analysis of marker compounds in HSPWS prepared by different methods and commercial formulation was also evaluated successfully.
authors.affiliation: Department of Oriental Pharmacy, College of Pharmacy, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.
authors.forename: Dipak Kumar
authors.initials: DK
authors.lastname: Sharma
authors.affiliation: Department of Agricultural Biology, National Academy of Agricultural Science, Suwon 441-853, Republic of Korea.
authors.forename: Se-Gun
authors.initials: SG
authors.lastname: Kim
authors.affiliation: Department of Oriental Pharmacy, College of Pharmacy, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.
authors.forename: Ramakanta
authors.initials: R
authors.lastname: Lamichhane
authors.affiliation: Department of Oriental Pharmacy, College of Pharmacy, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.
authors.forename: Kyung-Hee
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Department of Pharmacy, School of Health and Allied Sciences, Pokhara University, Kaski, Nepal.
authors.forename: Amrit
authors.initials: A
authors.lastname: Poudel
authors.affiliation: Department of Oriental Pharmacy, College of Pharmacy, Wonkwang University, Iksan, Jeonbuk, Republic of Korea hyun104@wku.ac.kr.
authors.forename: Hyun-Ju
authors.initials: HJ
authors.lastname: Jung
mesh_terms: D000818:Animals; D002138:Calibration; D002853:Chromatography, Liquid / Q000379:methods*; D004365:Drugs, Chinese Herbal / Q000737:chemistry*; D057230:Limit of Detection; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
chemical_list: D004365:Drugs, Chinese Herbal