Abstract

This work illustrates four different spectrophotometric methods for metformin (MET) and canagliflozin (CANA) quantification in their recently approved pharmaceutical with trade name Invokamet^®. The proposed methods are simple, definitive and accurate. Certain ensuing steps implementing zero spectra and/or ratio and/or derivative spectra were applied. Via implementing spectrum subtraction method accompanied with constant multiplication, zero order spectra were obtained for these drugs followed by their determination at their correlated λ_max at 237 and 290 nm for MET and CANA, respectively. Meanwhile, through employing method of derivative subtraction the two drugs were obtained in their first derivative spectra and quantified at 242.7 and 319.0 nm for MET and CANA, respectively. The suggested methods were inspected via laboratory prepared (diverse ratios) mixtures and they were excellently applied for analysis of Invokamet^® tablets. Moreover, sample enrichment via spiking technique was elected for a pharmaceutical formulation analysis containing CANA as a minor component. Accuracy, precision and specificity were between the valid limits. Validation steps were done in accordance with the ICH guidelines. Also, statistical compression was carried out between the obtained and reported results and no crucial divergence appeared.

中文翻译：

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在存在二甲双胍的分光光度法测定之前，测定样品中的Canagliflozin的浓度：在最近批准的二元剂量形式中的应用

摘要

这项工作说明了二甲双胍（四种不同的分光光度法MET）和卡格列净（CANA）量化在他们最近批准的药品商品名为Invokamet ^®。所提出的方法简单，确定且准确。应用了某些随后实现零光谱和/或比率和/或导数光谱的步骤。通过实施伴随有恒定乘法谱减法方法中，这些药物，随后可以通过确定在它们的相关的λ获得零级光谱_最大MET和CANA分别在237和290 nm处发射。同时，采用导数减法的方法获得了这两种药物的一阶导数光谱，并分别在MET和CANA的242.7和319.0 nm处进行了定量。所提出的方法进行了检查经由实验室制备的（不同比例）的混合物和它们良好地适用于Invokamet的分析^®片剂。此外，选择了通过加标技术进行样品富集用于含有CANA作为次要成分的药物制剂分析。准确度，精确度和特异性均在有效范围之内。验证步骤按照ICH指南进行。此外，在获得的结果和报告的结果之间进行了统计压缩，没有出现严重的分歧。