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KMID : 0385520190320040147
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Analytical Science & Technology
2019 Volume.32 No. 4 p.147 ~ p.154
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Simultaneous determination of ampicillin sodium and sulbactam sodium in powder for injection by HPLC
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Mai Xuan-Lan
Pham Thuy-Vy
Han Ga-Hyun
Kum Su-Jin
Woo Sang-Hoon
Kang Jong-Seong
Woo Mi-Hee
Na Dong-Hee
Chun In-Koo
Chun In-Koo
Kim Kyeong-Ho
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Abstract
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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).
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KEYWORD
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high-performance liquid chromatography (HPLC), Korean Pharmacopoeia (KP XI), ampicillin sodium, sulbactam sodium, assay
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