注射用阿莫西林钠克拉维酸钾近红外定量分析通用性模型的建立

Establishment of Universal Quantitative Models for Determination of Amoxicillin Sodium and Clavulanate Potassium for Injection Using Near-infrared Reflectance Spectroscopy

目的利用近红外漫反射光谱分析技术和化学计量学的方法对注射用阿莫西林钠克拉维酸钾进行无损、快速定量分析。方法采集26批实验室自制样品和40批不同企业市售样品的近红外漫反射光谱,通过聚类分析确定校正集和验证集,采用偏最小二乘法(PLS)建立定量分析模型。结果 3个定量模型中阿莫西林浓度范围为21.28%～75.57%,克拉维酸浓度范围为2.67%～15.85%,水分范围为0.46%～15.7%。阿莫西林定量模型的交叉验证均方根误差(RMSECV)和预测均方根误差(RMSEP)分别为1.42%和1.54%;克拉维酸定量模型的RMSECV和RMSEP分别为0.56%和0.71%;水分定量模型的RMSECV和RMSEP分别为0.11%和0.14%。结论建立的3个非破坏性快速定量分析模型用于不同厂家生产的注射用阿莫西林钠克拉维酸钾样品测定是可行的。

OBJECTIVE To develop a near-infrared （NIR） reflectance spectroscopic quantitative method for rapid and non-destructive determination of amoxicillin sodium and clavulanate potassium for injection. METHODS Using cluster analysis method, diffuse reflectance spectra of 26 batches of simulated samples and 40 batches of commercial samples from different manufactures were divided into calibration and validation set. The calibration model was developed using partial least squares （PLS） algorithm. RESULTS Three quantitative methods were explored at the concentration ranges of 21.28%-75.57% for amoxicillin, 2.67%-15.85% for clavulanate potassium, 0.46%-15.7% for water. The root mean square errors of cross validation （RMSECV） and the root mean square errors of prediction （RMSEP） were 1.42% and 1.54% for amoxicillin, 0.56% and 0.71% for clavulanate, 0.11% and 0.14% for water, respectively. CONCLUSION Three nondestructive quantitative NIR methods used in this study are applicable for rapid analysis of amoxicillin sodium and clavulanate potassium for injection fromdifferent manufactures.