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KMID : 0385520170300030154
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Analytical Science & Technology
2017 Volume.30 No. 3 p.154 ~ p.158
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Development of HPLC assay method of fusidate sodium tablets
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Lee Ga-Jin
Choi Min
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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The Korean Pharmacopoeia (KP XI), British Pharmacopoeia (BP 2013) and Japanese Pharmacopoeia contain monographs for the quality control of raw fusidate sodium and its formulations using high performance liquid chromatography (HPLC). However, the assay method for the determination of fusidate sodium in commercial tablets is titration which is less specific than HPLC. In this study, we present an alternative HPLC method for quantitation of fusidate sodium in tablets. 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 = 0.9999), while the RSDs for intra- and inter-day precision were 0.25-0.37% and 0.11-0.60 %, respectively. Accuracies ranged from 99.46-100.85 %. Since the system suitability, 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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HPLC, Fusidate Sodium, Assay, Validation, Tablet dosage form
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