- P-ISSN 1225-0163
- E-ISSN 2288-8985
- Log In/Sign Up
- P-ISSN1225-0163
- E-ISSN2288-8985
- SCOPUS, ESCI, KCI
Article Detail
Home > Article Detail
Simultaneous determination of ampicillin sodium and sulbactam sodium in powder for injection by HPLC
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2019, v.32 no.4, pp.147-154
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Chungnam National University)
(College of Pharmacy, Catholic University of Daegu)
(College of Pharmacy, Chungang University)
(The Research Foundation for Pharmaceutical Quality)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Kangwon National University)
(College of Pharmacy, Chungnam National University)
(College of Pharmacy, Catholic University of Daegu)
(College of Pharmacy, Chungang University)
(The Research Foundation for Pharmaceutical Quality)
(College of Pharmacy, Kangwon National University)
Xuan-Lan,
M.
, Thuy-Vy,
P.
, Ga-Hyun,
H.
, Su-Jin,
K.
, Sang-Hoon,
W.
, Jong-Seong,
K.
, Mi,
H.
W.
, Dong-Hee,
N.
, In-Koo,
C.
, &
(2019). Simultaneous determination of ampicillin sodium and sulbactam sodium in powder for injection by HPLC. Analytical Science and Technology, 32(4), 147-154.
- Downloaded
- Viewed
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 highperformance 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 (r2 > 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
Reference
1
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
2. C. González, A. García, R. Urrea, E. del Solar, H. Bello, and R. Zemelman, Rev. Med. Chil., 118(5), 548-554(1990).
3
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
4. M. Akova, Clin. Microbiol. Infect., 14, Suppl 1, 185-188 (2008).
5
5. P. I. Rafailidis, E. N. Ioannidou, and M. E. Falagas, Drugs. 67(13), 1829-1849 (2007).
6
6. K. Tsuji and J. H. Robertson, J. Pharm. Sci., 64(9), 1542-1545 (1975).
7
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).
8
8. S. S. Zarapkar, U. P. Halkar, and S. H. Rane, Indian Drugs, 37(4), 200-203 (2000).
9
9. C. M. Carceles, A. Espuny, M. S. Vicente, M. S. Diaz, E. Escudero, Res. Vet. Sci., 61, 143-146 (1996).
10
10. J. Haginaka and Y. Nishimura, J. Chromatogr., 532(1), 87-94 (1990).
11
11. Ministry of Food and Drug Safety, The Korean Pharmacopoeia, 11th Edition, Republic of Korea (2014).
12
12. The United States Pharmacopeia Convention, The United States Pharmacopeia, USP 41 NF 36, United States (2017).
13
13. The Ministry of Health, Labour and Welfare, The Japanese Pharmacopoeia, 17 Edition, Japan (2016).
14
14. ICH Guideline. Q2(R1): validation of Analytical Procedures: Text and Methodology Q2(R1) in ICH Harmonised Tripartite Guideline (2005).
15
15. Ministry of Food and Drug Safety No. 2009-173 (2009. 12. 15), Republic of Korea.
16
16. Ministry of Food and Drug Safety, No. C0-2012-2-005(2012. 09. 19), Republic of Korea.
Other articles from this issue
- Tandem laser-induced breakdown spectroscopy laser-ablation inductively-coupled plasma mass spectrometry analysis of high-purity alumina powder
- Investigation of physical characteristics for Al2O3:C dosimeter using LM-OSL
- An HPLC-UV-based quantitative analytical method for Chrysanthemum morifolium: development, validation, and application
- Simultaneous determination of ampicillin sodium and sulbactam sodium in powder for injection by HPLC
- Application study of PCR additives to improve the split peaks in direct PCR
- more
Recommanded Articles
This website recommended the use the Chrome browser for journal website.