title: Rapid Analysis of the Quality of Amoxicillin and Clavulanate Potassium Tablets Using Diffuse Reflectance Near-Infrared Spectroscopy.
abstract: The cycle-closed dimer of amoxicillin influences its critical quality and is an important impurity in amoxicillin and clavulanate potassium tablets. The quality of the tablets could be rapidly evaluated using the impurity as an indicator. Here, we report a quantitative model to determine the cycle-closed dimer in samples from different manufacturers using diffuse reflectance near-infrared (NIR) spectroscopy by partial least squares regression for one y variable (PLS1) and hierarchical cluster analysis. Because the contents of the (active pharmaceutical ingredients) APIs (amoxicillin and clavulanate potassium) and water are also the important indexes of the tablet quality, three other quantitative models were used to confirm the API data and water content. All of the four models facilitate rapid and complete control of the tablet quality. In addition, quantitative models were validated in terms of specificity, linearity, accuracy, repeatability, and intermediate precision according to the International Conference on Harmonisation guidelines by evaluating the characteristics of the NIR spectra. These results confirmed that the models were satisfactory.
authors: National Institutes for Food and Drug Control (NIFDC), Beijing, 100050, People's Republic of China. chongxm@sina.com.cn.
authors: Xiao-Meng
authors: XM
authors: Chong
authors: National Institutes for Food and Drug Control (NIFDC), Beijing, 100050, People's Republic of China.
authors: Wen-Bo
authors: WB
authors: Zou
authors: National Institutes for Food and Drug Control (NIFDC), Beijing, 100050, People's Republic of China.
authors: Shang-Chen
authors: SC
authors: Yao
authors: National Institutes for Food and Drug Control (NIFDC), Beijing, 100050, People's Republic of China.
authors: Chang-Qin
authors: CQ
authors: Hu
mesh_terms: D000658:Amoxicillin / Q000592:standards*; D019818:Clavulanic Acid / Q000592:standards*; D016018:Least-Squares Analysis; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets / Q000592:standards
chemical_list: D013607:Tablets; D019818:Clavulanic Acid; D000658:Amoxicillin
keywords: amoxicillin and clavulanate potassium tablet; diffuse reflectance near-infrared spectroscopy; quantitative model