Construction of Universal Quantitative Models for Determination of Cefoperazone Sodium for Injection from Different Manufacturers Using Near Infrared Reflectance Spectroscopy
PANG Huan-huan1, 2, FENG Yan-chun1, 4, HU Chang-qin1*, XIANG Bing-ren3
1. National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China 2. Jilin Institute of Drug Control, Changchun 130062, China 3. China Pharmaceutical University, Nanjing 210009, China 4. Institute of Medicinal Biotechnology, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China
Abstract：Universal quantitative models using NIR reflectance spectroscopy in two different kinds of sampling mode were developed for the analysis of cefoperazone sodium for injection from different manufacturers in China. The quantitative models were established using partial least squares(PLS). Nineteen batches of cefoperazone sodium for injection samples from 9 different manufacturers were predicted by the quantitative models. The root mean square errors of cross validation (RMSECV) and the root mean square errors of prediction (RMSEP) of the model in integrating sphere sampling mode were 0.99 and 0.98, respectively. The values of RMSECV and RMSEP of the model in fibre sampling mode were 1.12 and 1.17, respectively. Based on the ICH guidelines and characteristics of NIR spectra, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, and precision. The authors’ study has shown that it is feasible to build a universal quantitative model in fibre sampling mode for quick analysis of pharmaceutical products from different manufacturers. As a result of its good specificity and applicability, the model could be used for quick, non-destructive prescreening of counterfeit and substandard drugs in the mobile vehicle.
逄焕欢1, 2, 冯艳春1, 4,胡昌勤1*,相秉仁3 . 不同生产厂家注射用头孢哌酮钠含量测定的近红外定量模型的建立[J]. 光谱学与光谱分析, 2006, 26(12): 2214-2218.
PANG Huan-huan1, 2, FENG Yan-chun1, 4, HU Chang-qin1*, XIANG Bing-ren3 . Construction of Universal Quantitative Models for Determination of Cefoperazone Sodium for Injection from Different Manufacturers Using Near Infrared Reflectance Spectroscopy. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2006, 26(12): 2214-2218.
[1] LU Wan-zhen, et al(陆婉珍, 等). Modern Near Infrared Spectroscopy Analysis Technology(现代近红外光谱分析技术). Beijing: Petrolic and Chemical Industry Press(北京：中国石化出版社)，2000. 1. [2] SUN Mei-ling, et al(孙美玲, 等). Journal of China Pharmaceutical University(中国药科大学学报)，2003，34(3)：240. [3] BAI Ying-kui, SHEN Xuan-guo, FENG YI, et al(白英奎, 申铉国, 冯 毅, 等). Spectroscopy and Spectral Analysis(光谱学与光谱分析)，2005，25(6)：898. [4] SUN Mei-ling, et al(孙美玲, 等). Journal of China Pharmaceutical University(中国药科大学学报)，2003，34(5)：473. [5] Scafi S H F, Pasquini C. Analyst, 2001, 126: 2218. [6] Olsen B A, Borer M W. Pharmaceutical Technology, 2002, 6: 62. [7] HU Chang-qin, et al(胡昌勤, 等). Chinese Pharmaceutical(中国药事)，2004，18(4)：250. [8] The Pharmacopoeia Committee of the People’s Republic of China(国家药典委员会). Chinese Pharmaceutical(中国药典·二部). Beijing: Chemical Industry Press(北京: 化学工业出版社), 2000. 938. [9] YANG Li-hong, et al(杨利红, 等). Chinese Pharmaceutical(中国药事), 2001, 15,(4): 256. [10] Moffat Anthony C, Trafford Andrew D. Analyst, 2000, 125: 1341.
