- P-ISSN 1225-0163
- E-ISSN 2288-8985
- 권한신청
- P-ISSN1225-0163
- E-ISSN2288-8985
- SCOPUS, ESCI, KCI
논문 상세
Home > 논문 상세
Development of HPLC assay method of fusidate sodium tablets
분석과학 / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2017, v.30 no.3, pp.154-158
https://doi.org/10.5806/AST.2017.30.3.154
(강원대학교)
(강원대학교)
(강원대학교)
(강원대학교)
(강원대학교)
(충남대학교)
(대구가톨릭대학교)
(중앙대학교)
(The Society of Korean Official Compendium for Public Health)
(강원대학교)
(강원대학교)
(강원대학교)
(강원대학교)
(충남대학교)
(대구가톨릭대학교)
(중앙대학교)
(The Society of Korean Official Compendium for Public Health)
이가진,
김경호,
최민,
Quoc,
K.
T.
,
Xuan,
L.
M.
,
강종성,
우미희,
나동희,
&
전인구.
(2017). . 분석과학, 30(3), 154-158, https://doi.org/10.5806/AST.2017.30.3.154
- 다운로드 수
- 조회수
Abstract
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).
- keywords
- HPLC, Fusidate Sodium, Assay, Validation, Tablet dosage form
참고문헌
1
1. Merck Research Laboratories, The Merck Index, 14th Ed., United States (2006).
2
2. A. H. Hikal, A. Shibl, and S. El-Hoofy, J. Pharm. Sci., 71(11), 1297-1298 (1982).
3
3. The Ministry of Health, Labour and Welfare, The Japanese Pharmacopoeia, 17th Ed., Japan (2016).
4
4. Ministry of Food and Drug Safety, The Korean Pharmacopoeia, 11th Ed., Republic of Korea (2014).
5
5. Medicines & Healthcare Products Regulatory Agency, British Pharmacopoeia, 7th Ed., United Kingdom (2013).
6
6. The United States Pharmacopeial Convention, The United States Pharmacopeia, USP 39 NF 34, United States (2016).
7
7. J. Byrne, T. Velasco-Torrijos, and R. Reinhardt, J. Pharm. Biomed. Anal., 96, 111-117 (2014).
8
8. S. Shaikh, M.S. Muneera, O.A Thusleem, M. Tahir, and A. V. Kondaguli, J. Chromato. Sci., 47, 178-183 (2009).
9
9. M. Nawaz, M. S. Arayne, N. Sultana, A. Haider, and S. Hisaindee, Acta Chromatogr., 26, 57-66 (2014).
10
10. J. Byrne, T. Velasco-Torrijos, and R. Reinhardt, J. Chromato. Sci., 53, 1498-1503 (2015).
11
11. H. Sorensen, J. Chromatography, 430, 400-408 (1988).
12
12. R. Leclercq, R. Bismuth, I. Casin, J. D. Cavallo, J. Croize, A. Felten, F. Goldstein, H. Monteil, C. Quentin-Noury, M. Reverdy, M. Vergnaud, and R. Roiron, J. Antimicrob. Chemother., 45(1), 27-29 (2000).
13
13. ICH Guideline. Q2(R1): validation of Analytical Procedures: Text and Methodology Q2(R1) in ICH Harmonised Tripartite Guideline (2005).
14
14. Ministry of Food and Drug Safety No. 2009-173 (2009.12. 15), Republic of Korea.
15
15. Ministry of Food and Drug Safety, No. C0-2012-2-005(2012. 09. 19), Republic of Korea.
권호 내 다른 논문
- Antibacterial and phytochemical properties of Aphanamixis polystachya essential oil
- Comparative analysis of urinary metabolites in methamphetamine self-administrated rats
- Development of HPLC method for differentiation of three parts of mulberry tree
- Effect of microwave irradiation on lipase-catalyzed reactions in ionic liquids
- Ginsenosides analysis in the crude saponin fraction extracted from Korean red ginseng, and its efficacious analysis against acute pulmonary inflammation in mice
- Development of HPLC assay method of fusidate sodium tablets
- more
추천 논문
학술지 홈페이지 이용 환경은 크롬 브라우저 사용을 권장합니다.