当前位置: X-MOL 学术Talanta Open › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Determination of the quality of metronidazole formulations by near-infrared spectrophotometric analysis
Talanta Open ( IF 4.1 ) Pub Date : 2020-12-31 , DOI: 10.1016/j.talo.2020.100027
Abdoul Karim SAKIRA , Corenthin MEES , Kris De BRAEKELEER , Cédric DELPORTE , Josias YAMEOGO , Moussa YABRE , Touridomon Issa SOME , Pierre Van ANTWERPEN , Dominique MERTENS , Jean Michel KAUFFMANN

In the quality control of medicines and the fight against the phenomenon of poor quality medicines, there is an urgent need for rapid and broad spectrum methods for screening these types of medicines. In the present work, we have used near infrared spectroscopy combined with multivariate data analysis to develop chemometric models for the classification and quantification of metronidazole in Burkina Faso pharmaceutical formulations. For this purpose, drug samples were collected in drugstores located in different Burkina Faso border zones. Four product classes were defined based on the national nomenclature: 3 classes for the generic drugs (C1, C3, and C4) and one class for the reference (C2) drugs. The exploratory analysis using PCA identified two clusters of drugs within class C1. Discrimination was confirmed by the developed and optimised DD-SIMCA model, with only one target class. The quality control of the samples from product class C1 was proven to be very satisfactory with specificities and sensitivities of 100%. The quantification models developed with the PLS-R method were successfully applied for the determination of the active ingredient content in the samples, with acceptable relative bias between 0.15 and 12.7 % with respect to the dose determined by the HPLC method. The RMSEC was estimated at 13.57 (R2, 0.9937), the RMSECV at 18.07 (R2, 0.9888) and the RMSEP at 13.69 (R2, 0.9941).The models developed and the results obtained are promising for routine quality control of similar formulations of metronidazole.



中文翻译:

近红外分光光度法测定甲硝唑制剂的质量

在药物的质量控制和与劣质药物现象作斗争中,迫切需要一种快速和广谱的方法来筛选这些类型的药物。在目前的工作中,我们已使用近红外光谱结合多元数据分析来开发化学计量学模型,用于对布基纳法索药物制剂中的甲硝唑进行分类和定量。为此,在布基纳法索不同边境地区的药房收集了毒品样品。根据国家命名法定义了四类产品:三类为仿制药(C1,C3和C4),一类为参比药物(C2)。使用PCA进行的探索性分析确定了C1类中的两类药物。通过开发和优化的DD-SIMCA模型(只有一个目标类别)确认了歧视。事实证明,来自C1类产品的样品的质量控制非常令人满意,特异性和敏感性均为100%。用PLS-R方法开发的定量模型已成功应用于样品中活性成分的测定,相对于HPLC方法测定的剂量,相对偏差在0.15和12.7%之间。RMSEC估计为13.57(R 用PLS-R方法开发的定量模型已成功应用于样品中活性成分的测定,相对于HPLC方法测定的剂量,相对偏差在0.15和12.7%之间。RMSEC估计为13.57(R 用PLS-R方法开发的定量模型已成功应用于样品中活性成分的测定,相对于HPLC方法测定的剂量,相对偏差在0.15和12.7%之间。RMSEC估计为13.57(R2,0.9937),在18.07 R中的RMSECV(2,0.9888),并在13.69的RMSEP(R 2,0.9941)开发.The模型和所获得的结果是有希望的甲硝唑的类似制剂的常规质量控制。

更新日期:2021-01-06
down
wechat
bug