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http://dx.doi.org/10.5806/AST.2019.32.4.147

Simultaneous determination of ampicillin sodium and sulbactam sodium in powder for injection by HPLC  

Mai, Xuan-Lan (College of Pharmacy, Kangwon National University)
Pham, Thuy-Vy (College of Pharmacy, Kangwon National University)
Han, Ga-Hyun (College of Pharmacy, Kangwon National University)
Kum, Su-Jin (College of Pharmacy, Kangwon National University)
Woo, Sang-Hoon (College of Pharmacy, Kangwon National University)
Kang, Jong-Seong (College of Pharmacy, Chungnam National University)
Woo, Mi Hee (College of Pharmacy, Catholic University of Daegu)
Na, Dong-Hee (College of Pharmacy, Chungang University)
Chun, In-Koo (The Research Foundation for Pharmaceutical Quality)
Kim, Kyeong Ho (College of Pharmacy, Kangwon National University)
Publication Information
Analytical Science and Technology / v.32, no.4, 2019 , pp. 147-154 More about this Journal
Abstract
Ampicillin and Sulbactam (2:1, w/w) are combined in formulation to provide broader antibacterial action in treatment of many infections. The development of analytical method for simultaneouly determine these two compounds was difficult because of the differences in their chemical structures and ratio in the formulation. Current published methods still have some limitations. In this study, we developed an alternative high-performance liquid chromatography (HPLC) assay method for simultaneously determination of ampicillin sodium and sulbactam sodium in powder for injection. Method validation of HPLC method was conducted to determine linearity, precision, accuracy, system suitability, robustness. The linearity of the calibration curves in the desired concentration range was good ($r^2$> 0.9994). RSDs of intra-day and inter-day precision obtained were less than 2.00 %. Accuracy was obtained with the recoveries in range of 98.42 % and 101.36 %. As a result of system suitability, RSD of both retention time and the peak area obtained were not more than 1.0 %. The values of plate number were more than 7000 and symmetric factors obtained were 0.8. As intermediate-precision and robustness of the developed assay, it could be expected to become valuable tools for revising the Korean Pharmacopoeia (KP XI).
Keywords
high-performance liquid chromatography (HPLC); Korean Pharmacopoeia (KP XI); ampicillin sodium; sulbactam sodium; assay;
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  • Reference
1 National Cancer Institute Terminologies (NCIt), Record Name: Ampicillin Sodium, https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=NCI_Thesaurus&code=C47959.
2 C. Gonzalez, A. Garcia, R. Urrea, E. del Solar, H. Bello, and R. Zemelman, Rev. Med. Chil., 118(5), 548-554 (1990).
3 National Cancer Institute Terminologies (NCIt), Record Name: Sulbactam Sodium, https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=NCI_Thesaurus&code=C47732.
4 M. Akova, Clin. Microbiol. Infect., 14, Suppl 1, 185-188 (2008).   DOI
5 P. I. Rafailidis, E. N. Ioannidou, and M. E. Falagas, Drugs. 67(13), 1829-1849 (2007).   DOI
6 K. Tsuji and J. H. Robertson, J. Pharm. Sci., 64(9), 1542-1545 (1975).   DOI
7 R. G. Lauback, J. J. Rice, B. Bleiberg, N. Muhammad, and S. A. Hanna, J. Liq. Chromatogr. Relat. Technol., 7(6), 1243-1265 (1984).   DOI
8 S. S. Zarapkar, U. P. Halkar, and S. H. Rane, Indian Drugs, 37(4), 200-203 (2000).
9 C. M. Carceles, A. Espuny, M. S. Vicente, M. S. Diaz, E. Escudero, Res. Vet. Sci., 61, 143-146 (1996).   DOI
10 J. Haginaka and Y. Nishimura, J. Chromatogr., 532(1), 87-94 (1990).   DOI
11 Ministry of Food and Drug Safety, The Korean Pharmacopoeia, 11th Edition, Republic of Korea (2014).
12 The United States Pharmacopeia Convention, The United States Pharmacopeia, USP 41 NF 36, United States (2017).
13 The Ministry of Health, Labour and Welfare, The Japanese Pharmacopoeia, 17 Edition, Japan (2016).
14 ICH Guideline. Q2(R1): validation of Analytical Procedures: Text and Methodology Q2(R1) in ICH Harmonised Tripartite Guideline (2005).
15 Ministry of Food and Drug Safety No. 2009-173 (2009. 12. 15), Republic of Korea.
16 Ministry of Food and Drug Safety, No. C0-2012-2-005 (2012. 09. 19), Republic of Korea.