Development and Validation of Analytical Method for Qualitative and Quantitative Determination of Glibenclamide in Different Brands of Tablet Dosage form Using UV-Visible Spectroscopy

Abstract

This paper describes a methodology to develop a new method for qualitative and quantitative determination of glibenclamide (GLB) in three brands of GLB tablets. We validated the developed method for linearity, accuracy, precision, limit of detection (LOD) and limit of quantification (LOQ) according to the guidelines of the International Conference on Harmonization. Finally, we estimated the qualitative and quantitative amount of GLB in three brands of GLB tablets using validated method. A non significant difference was observed in the dissolution profiles of GLB in these tablets. Validation of developed method showed that a linear relationship (r 2 >0.999) was observed at maximum absorbance (λ max ) at 229.5 nm with concentration range of 3-15 μg/ml GLB. Accuracy of developed method was found to be within the limit of 95-105%. The percent relative standard deviation (%RSD) and percent relative error (%RE) for precision was found to be <3%. In three brands of GLB tablets, values of LOD and LOQ were 10 ng/ml and 35 ng/ml respectively. We also found that the amount of GLB in each tablet corresponded to the requirements of 95-105% of the label claimed in tablet. From the results of validation of developed method, it concluded that developed method showed satisfactory linearity, precision and accuracy for analysis of active ingredients of commercially available pharmaceutical products.

Development and comparison of two competitive ELISAs for estimation of cotinine in human exposed to environmental tobacco smoke

“…[25] In our previous studies, we also developed competitive ELISAs to quantify tartrazine, bisphenol A (BPA), and aflatoxin M 1 in human urinary samples. [25] In our previous studies, we also developed competitive ELISAs to quantify tartrazine, bisphenol A (BPA), and aflatoxin M 1 in human urinary samples.…”

“…Development and validation of a new analytical is very important for precision and accuracy. [25] In our previous studies, we also developed competitive ELISAs to quantify tartrazine, bisphenol A (BPA), and aflatoxin M 1 in human urinary samples. [19,26,27] Moreover, we also developed a new method for the sustained delivery interleukin-1 receptor antagonist [28][29][30][31] for the treatment of diabetes mellitus.…”

Development of therapeutic proteins: advances and challenges

“…These two have the ability to dampen the unwanted immunogenic responses (De Groot et al, 2008); however, it is still unclear whether these strategies will help minimize the chances of immunogenicity observed with antibody-based therapeutics. Using established analytical methods (Bilal et al, 2013;Lei et al, 2013aLei et al, , 2013bLei et al, , 2013cLei et al, , 2014aLei et al, , 2014bLei et al, , 2015, immunogenicity associated with protein therapeutics cannot be accurately predicted. Pharmaceutical scientists are continuously trying their best to assess the potential of immunogenicity during the discovery phase and ultimately select a molecule with a minimal immunogenic profile as a clinical therapeutic candidate.…”

Determination of Glibenclamide By Analytical Spectrophotometry

“…The estimation of (GB) from pharmaceutical formulations has been determining by several analytical methods. These include UV spectroscopy methods [3][4][5][6][7][8][9] , spectrofluorimetric method 10 , reversed-phase high-performance liquid chromatography (RP-HPLC) methods [11][12] and high performance liquid chromatography (HPLC) [13][14] , high performance thin layer chromatography (HPTLC) [15][16] .…”