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KMID : 0385520160290060277
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Analytical Science & Technology
2016 Volume.29 No. 6 p.277 ~ p.282
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Development of high performance liquid chromatography assay method of diosmin capsules
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Shim Dae-Hyun
Shin Dong-Han
Truong Quoc Ky
Mai Xuan Lan
Kang Jong-Seong
Woo Mi-Hee
Na Dong-Hee
Chun In-Koo
Kim Kyeong-Ho
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Abstract
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British Pharmacopoeia (BP 2013), the United States Pharmacopoeia (USP 39) and the Korean Pharmacopoeia (KP XI) contain monographs for the quality control of raw diosmin using high performance liquid chromatography (HPLC). However, official monographs detailing pharmaceutical formulations for diosmin are not available in foreign pharmacopoeias. In the KP XI, ultraviolet?visible (UV-Vis) spectroscopy?which is less specific than HPLC?is reported for the testing of diosmin capsules. In this study, we present an alternative HPLC assay for such testing that is more specific than UV-Vis methods. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high (r2>0.999), while the RSDs for intra- and inter-day precision were 0.15-0.29 % and 1.05-1.74%, respectively. Accuracies ranged from 101.2-103.2 %, while the retention time and peak area RSDs were 0.37 % and 0.06 %, respectively. Additionally, the plate number and asymmetry factor values for diosmin were 3591.293 and 1.35, respectively. Since the intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).
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KEYWORD
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Korean Pharmacopoeia(KP XI), diosmin capsule, assay, validation, high performance liquid chro-matography
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