Quality Control of Tramadol in Kisangani: Development, Validation, and Application of a UV-Vis Spectroscopic Method  

作　　者：Marguerite Borive Amani Jérémie Mbinze Kindenge Emile Tweni Baruti Elodie Nsasi Bakiantima Salomon Batina Agasa Philippe Hubert Roland Marini Djang’eing’a Marguerite Borive Amani;Jérémie Mbinze Kindenge;Emile Tweni Baruti;Elodie Nsasi Bakiantima;Salomon Batina Agasa;Philippe Hubert;Roland Marini Djang’eing’a(Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo;Laboratory of Drugs Analysis, Department of Galenic and Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo;Department of Internal Medicine, Faculty of Medicine and Pharmacy, University of Kisangani, Kinshasa, Democratic Republic of the Congo;Laboratory of Analytical Pharmaceutical Chemistry, Faculty of Medicine, University of Liège, Liège, Belgium)

机构地区：[1]Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo [2]Laboratory of Drugs Analysis, Department of Galenic and Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo [3]Department of Internal Medicine, Faculty of Medicine and Pharmacy, University of Kisangani, Kinshasa, Democratic Republic of the Congo [4]Laboratory of Analytical Pharmaceutical Chemistry, Faculty of Medicine, University of Liège, Liège, Belgium

出　　处：《American Journal of Analytical Chemistry》2021年第8期295-309,共15页美国分析化学（英文）

摘　　要：<strong>Context:</strong> Substandard and falsified medicines are circulating in low-income countries mostly without any control. We availed a simple and not expensive UV-Vis spectroscopic method to evaluate the quality of tramadol in Kisangani before and during the Covid-19 period. <strong>Methods:</strong> For the analytical quantitative method, an experimental design was applied to set up the optimal levels of the selected factors, namely, pH of dissolution medium, type of cuvette, and wavelength. Taking into account the capsule pharmaceutical formulation within 80 - 120 μg&middotmL^-1 concentration range, we analyzed 89 tramadol samples from pharmacies and hospitals of the six Kisangani municipalities. <strong>Results:</strong> pH showed a significant effect on absorbance, whereas quartz cuvette and wavelength did not. A typical 100 μg&middotmL^-1 tramadol solution gave an absorbance of 0.64 at 272 nm. Validation highlighted a matrix effect observed with a 6% bias. A correction factor of 0.9372 allowed to improve the accuracy profile, which were then totally included within the 10% acceptance limits. Quality control revealed that 25 samples out of 89 were not compliant in terms of manufacturing license, registration status in DRC and content as well. <strong>Conclusion:</strong> This study showed that the strengthening of analytical strategy in Kisangani is a need.<strong>Context:</strong> Substandard and falsified medicines are circulating in low-income countries mostly without any control. We availed a simple and not expensive UV-Vis spectroscopic method to evaluate the quality of tramadol in Kisangani before and during the Covid-19 period. <strong>Methods:</strong> For the analytical quantitative method, an experimental design was applied to set up the optimal levels of the selected factors, namely, pH of dissolution medium, type of cuvette, and wavelength. Taking into account the capsule pharmaceutical formulation within 80 - 120 μg&middotmL^-1 concentration range, we analyzed 89 tramadol samples from pharmacies and hospitals of the six Kisangani municipalities. <strong>Results:</strong> pH showed a significant effect on absorbance, whereas quartz cuvette and wavelength did not. A typical 100 μg&middotmL^-1 tramadol solution gave an absorbance of 0.64 at 272 nm. Validation highlighted a matrix effect observed with a 6% bias. A correction factor of 0.9372 allowed to improve the accuracy profile, which were then totally included within the 10% acceptance limits. Quality control revealed that 25 samples out of 89 were not compliant in terms of manufacturing license, registration status in DRC and content as well. <strong>Conclusion:</strong> This study showed that the strengthening of analytical strategy in Kisangani is a need.

关 键 词：TRAMADOL UV-Vis Spectroscopy Method Development VALIDATION Quality Control 

分 类 号：R61[医药卫生—外科学]