Physicochemical Equivalence and Validation of an HPLC Analytical Method for the Quantification of Glibenclamide and Its Sulfonamide Impurity in Prescribed Glibenclamide Tablets in Nigeria

Simple item page
dc.contributor.authorJosephine, Oluwagbemisola Tellaen_US
dc.contributor.authorSaheed, Oluwasina Osenien_US
dc.contributor.authorBasheeru, Kazeem Adebayoen_US
dc.date.accessioned2020-10-16T08:52:26Z
dc.date.available2020-10-16T08:52:26Z
dc.date.issued2019-03
dc.description.abstractObjective: To investigate the physicochemical equivalence of four brands of commercially available glibenclamidetablets in Nigeria and to develop a validation method using HPLC for the quantitative determination of glibenclamide and its sulfonamide impurity present in thesetablets.Methods: Uniformity of weight, friability tests, hardness/crushing strength, dissolution,anddisintegration tests were carried out on tablets/drug samples of each brand. Theirfunctional groups were determined and compared with pure glibenclamide sample (reference standard) using Fourier Original Research Article Transform Infrared Spectroscopy (FTIR) between a range of 4000cm-1to 400cm-1. High-Performance Liquid Chromatography (HPLC) was used to determine the percentage of glibenclamide and its sulfonamide impurity present in each tablet brand. Results: From the physicochemical evaluation of the four brands ofglibenclamide tablets tested, the brands passed all the British Pharmacopeia specifications,but they all failed the hardness/crushing strength tests and one of the brands failed the assay test requirement for drug content. The developed HPLC method had apercentage recovery between the acceptable limit of 95-105% with percentage relative standard deviation (%RSD) of < 3% while the precision of the method was 0.102%and 0.383% for glibenclamide and its sulfonamide impurity, respectively. The Limit of Detection (LOD)and Limit of Quantification (LOQ)of the developed analytical method for the four brands were 0.075μg/ml and 0.227μg/ml for glibenclamide while that of sulfonamide impurity were0.114μg/ml and 0.345μg/ml,respectively.In addition, the percentage impurity of sulfonamide in all the brands was less than the acceptable limit of 1%.Conclusion: Theresultsfrom thephysicochemical evaluation of the glibenclamide brands justified the need forconstant monitoring of marketed drug products. The results obtained from theHPLC quantification methoddeveloped for this study show that our data is reproducible based on the linearity, precision, and accuracyof data generated forglibenclamide and its sulfonamide impurity inthe four brands of glibenclamide tablets prescribed to DM patients in Nigeria, which were judged to besatisfactoryat the time of this studyen_US
dc.identifier.affiliationsDepartment of Pharmaceutical Technology, Moshood Abiola Polytechnic, Abeokuta, Nigeriaen_US
dc.identifier.affiliationsDepartment of Industrial Chemistry, Covenant University, Ota, Nigeriaen_US
dc.identifier.affiliationsDepartment of Biological Sciences, Florida Atlantic University, Davie, Florida, USAen_US
dc.identifier.affiliationsCollege of Veterinary Medicine, Federal University of Agriculture, Abeokuta, Nigeriaen_US
dc.identifier.affiliationsDepartment of Chemistry, University of Ilorin, Nigeriaen_US
dc.identifier.citationJosephine Oluwagbemisola Tella, Saheed Oluwasina Oseni, Basheeru Kazeem Adebayo. Physicochemical Equivalence and Validation of an HPLC Analytical Method for the Quantification of Glibenclamide and Its Sulfonamide Impurity in Prescribed Glibenclamide Tablets in Nigeria. Journal of Advances in Medicine and Medical Research. 2019 Mar; 29(1): 1-17en_US
dc.identifier.issn2456-8899
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/210100
dc.languageenen_US
dc.publisherSCIENCEDOMAIN internationalen_US
dc.relation.issuenumber1en_US
dc.relation.volume29en_US
dc.source.urihttps://dx.doi.org//10.9734/JAMMR/2019/v29i130053en_US
dc.subjectGlibenclamideen_US
dc.subjectDiabetes mellitusen_US
dc.subjectHPLCen_US
dc.subjectFTIRen_US
dc.subjectSulfonamide impurityen_US
dc.titlePhysicochemical Equivalence and Validation of an HPLC Analytical Method for the Quantification of Glibenclamide and Its Sulfonamide Impurity in Prescribed Glibenclamide Tablets in Nigeriaen_US
dc.typeJournal Articleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
jammr2019v29n1pd1.pdf
Size:
1.03 MB
Format:
Adobe Portable Document Format
Download
Collections
Journal of Advances in Medicine and Medical Research