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KMID : 1142220120070010021
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Regulatory Research on Food, Drug & Cosmetic
2012 Volume.7 No. 1 p.21 ~ p.25
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Development of Analytical Method of 5%-Phytonadione by HPLC
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Kim Dong-Hwan
Choi Yeon-Hee
Lee Su-Jung
Lee Kyu-Ha
Lee Eun-Sun
Choi Lan
Sohn Kyung-Hee
Kim Dong-Sub
Kim In-Kyu
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Abstract
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In this study, We have proposed developed assay of ‘5% phytonadione’ in Korean Pharmaceutical Codex. Suggested test methods was developed by HPLC with ultraviolet detector. The assay was performed in an isocratic elution using a mobile phase composition of dehydrated ethanol and distilled water (95:5, v/v) and the analyte was monitored at 254 nm. The developed method was validated through linearity, range, system suitability, precision, accuracy, recovery and inter-laboratory variation according to the 「Guideline on analytical procedures and method validation of pharmaceutical products」(KFDA, 2008.12). The results of these study showed high specificity for 5% pytonadione. The coefficient of determination (R2) was 0.9998 and the recovery was 100.2%. Evaluation of precision was performed by comparative analysis of two equipments, and each equipment showed the relative standard deviations (RSD) 0.4% and 0.2%. The developed method was successfully applied to estimate the amount of phytonadione in 5% Phytonadione.
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KEYWORD
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phytonadione, HPLC, KPC
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