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

被引：4

作者：

Mai, Xuan-Lan ^{[1
]}

Thuy-Vy Pham ^{[1
]}

Han, Ga-Hyun ^{[1
]}

Kum, Su-Jin ^{[1
]}

Woo, Sang-Hoon ^{[1
]}

Kang, Jong-Seong ^{[2
]}

Woo, Mi Hee ^{[3
]}

Na, Dong-Hee ^{[4
]}

Chun, In-Koo ^{[5
]}

Kim, Kyeong Ho ^{[1
]}

机构：

[1] Kangwon Natl Univ, Coll Pharm, Chunchon 24341, South Korea

[2] Chungnam Natl Univ, Coll Pharm, Daejeon 34134, South Korea

[3] Catholic Univ Daegu, Coll Pharm, Gyongsan 38430, South Korea

[4] Chung Ang Univ, Coll Pharm, Seoul 06974, South Korea

[5] Res Fdn Pharmaceut Qual, Seoul 03397, South Korea

来源：

ANALYTICAL SCIENCE AND TECHNOLOGY | 2019年 / 32卷 / 04期

关键词：

high-performance liquid chromatography (HPLC); Korean Pharmacopoeia (KP XI); ampicillin sodium; sulbactam sodium; assay;

D O I：

10.5806/AST.2019.32.4.147

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

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).

引用

页码：147 / 154

页数：8

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