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用光纤和积分球测量的近红外漫反射光谱分别建立可以测定不同厂家生产的头孢哌酮钠舒巴坦钠注射用粉针剂的定量分析模型。建立这两个模型共使用了6批市场销售的样品和42批实验室自制样品,头孢哌酮钠的浓度范围是30%～70%,舒巴坦钠的浓度范围是60%～20%。型号为EQUINOX55型近红外光谱仪用于模型的建立。对于头孢哌酮钠,积分球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1.79%和2.85%;光纤模型的结果是2.93%和2.92%。对于舒巴坦钠,积分球模型的RMSECV和RMSEP分别为1.86%和3.08%;光纤模型的结果是2.23%和3.01%。根据ICH的指导原则和参考文献12,从专属性、线性、准确度、精密度和粗放性以及模型传递等几个方面对模型进行了评价。我们的研究表明,建立非破坏性的通用性快速定量分析模型用以分析不同厂家生产的粉针剂样品是可行的。所以,近红外方法能被作为一种有效的方法快速、非破坏性的监督检查市场上流通的产品。
The quantitative analysis model of cefoperazone sodium and sulbactam sodium for injection injections can be established by using near-infrared diffuse reflectance spectroscopy measured by optical fiber and integrating sphere respectively. A total of six batches of commercially available samples and 42 batches of laboratory-produced samples were used to establish the two models. Concentrations of cefoperazone sodium ranged from 30% to 70% and sulbactam sodium ranged from 60% to 20%. Model EQUINOX55 near infrared spectrometer for modeling. The cross-validation root mean square error (RMSECV) and root mean square error of prediction (RMSEP) for the cefoperazone sodium and integral sphere model were 1.79% and 2.85%, respectively; the fiber model results were 2.93% and 2.92%. For sulbactam sodium, the RMSECV and RMSEP for the integrating sphere model were 1.86% and 3.08%, respectively; the fiber model results were 2.23% and 3.01%. According to ICH guidelines and reference 12, the model was evaluated from the aspects of specificity, linearity, accuracy, precision and extensiveness, and model transfer. Our research shows that it is feasible to establish non-destructive and rapid universal quantitative analysis models for the analysis of powder injection samples produced by different manufacturers. So, the near-infrared method can be used as an efficient method to quickly and non-destructively supervise and inspect products that are available on the market.