{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T12:50:22Z","timestamp":1791982222351,"version":"4.4.0"},"reference-count":72,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T00:00:00Z","timestamp":1791158400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T00:00:00Z","timestamp":1791158400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Triple fixed\u2010dose combinations (FDCs) comprising metformin, sodium\u2013glucose cotransporter\u20102 (SGLT2) inhibitors and dipeptidyl peptidase\u20104 (DPP\u20104) inhibitors have become an important therapeutic option for type 2 diabetes mellitus but present significant analytical challenges owing to differences in dose ratio, polarity, ionization behaviour, solubility, ultraviolet absorption and chemical stability. This review critically evaluates analytical methods for the simultaneous determination of these combinations in pharmaceutical dosage forms, including ultraviolet spectrophotometry, high\u2010performance thin\u2010layer chromatography, reversed\u2010phase and ultra\u2010performance liquid chromatography, capillary electrophoresis and liquid chromatography\u2013tandem mass spectrometry. Rather than describing published methods individually, the review comparatively assesses analytical performance, robustness, validation quality, stability\u2010indicating capability, greenness and suitability for routine pharmaceutical quality control within the context of ICH Q2(R2), ICH Q14, USP &lt;1220&gt; and Analytical Quality by Design (AQbD). A major contribution is the development and retrospective validation of a challenge\u2010based decision framework that integrates physicochemical properties, analytical objectives, regulatory requirements, laboratory capabilities and sustainability principles to support rational method selection. Validation against published methods demonstrated strong agreement with reported analytical strategies. Future perspectives highlight the potential of artificial intelligence, advanced chemometrics and emerging chromatographic technologies to advance analytical development for complex multicomponent pharmaceutical products.<\/jats:p>","DOI":"10.1002\/bmc.70617","type":"journal-article","created":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T12:15:22Z","timestamp":1791202522000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Challenge\u2010Oriented Decision Tree for Analytical Method Selection in Metformin, Sodium\u2013Glucose Cotransporter\u20102 (SGLT2) Inhibitors and Dipeptidyl Peptidase\u20104 (DPP\u20104) Inhibitors Triple Antidiabetic Fixed\u2010Dose Combinations in Pharmaceutical Dosage Forms"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1381-1369","authenticated-orcid":false,"given":"Imad Osman Abu","family":"Reid","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Chemistry, Faculty of Pharmacy International University of Africa  Khartoum Sudan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,5]]},"reference":[{"key":"e_1_2_17_2_1","doi-asserted-by":"publisher","DOI":"10.1155\/2026\/1129092"},{"key":"e_1_2_17_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc22\u2010S002"},{"key":"e_1_2_17_4_1","doi-asserted-by":"publisher","DOI":"10.21608\/EJCHEM.2024.161798.6953"},{"key":"e_1_2_17_5_1","doi-asserted-by":"publisher","DOI":"10.1515\/chem\u20102025\u20100230"},{"key":"e_1_2_17_6_1","doi-asserted-by":"publisher","DOI":"10.1039\/c5ra17231d"},{"key":"e_1_2_17_7_1","doi-asserted-by":"publisher","DOI":"10.31838\/ijpr\/2020.12.04.702"},{"issue":"11","key":"e_1_2_17_8_1","first-page":"302","article-title":"Analytical Perspectives on Chromatographic Method Development for Impurity Profiling in Pharmaceuticals","volume":"1","author":"Barge V.","year":"2025","journal-title":"Journal of Pharmaceutical Sciences"},{"key":"e_1_2_17_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2003.10.017"},{"key":"e_1_2_17_10_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP.8.4.271"},{"key":"e_1_2_17_11_1","unstructured":"Bened\u00e9 J. L. A.Chisvert andJ.Grau.2021. \u201cMoving Toward Green and Sustainable Sample Preparation. Recent Developments in Sample Preparation.\u201d39 no.s11:32\u201337."},{"key":"e_1_2_17_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpha.2013.09.003"},{"key":"e_1_2_17_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00216\u2010011\u20105308\u20105"},{"key":"e_1_2_17_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/10408347.2023.2253321"},{"key":"e_1_2_17_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.70162"},{"issue":"3","key":"e_1_2_17_16_1","first-page":"254","article-title":"Ion Pairing\u2014Blessing or Curse","volume":"26","author":"Dolan J. W.","year":"2008","journal-title":"LC GC North America"},{"key":"e_1_2_17_17_1","volume-title":"Back to Basics: The Role of pH in Retention and Selectivity","author":"Dolan J. W.","year":"2017"},{"key":"e_1_2_17_18_1","unstructured":"DrugBank. n.d. \u201cDrugBank: Online Database for Drug Information.\u201dhttps:\/\/go.drugbank.com\/drugs."},{"key":"e_1_2_17_19_1","doi-asserted-by":"publisher","DOI":"10.1590\/s2175\u201097902018000001006"},{"key":"e_1_2_17_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trac.2013.04.010"},{"key":"e_1_2_17_21_1","doi-asserted-by":"publisher","DOI":"10.1177\/15209156261449879"},{"key":"e_1_2_17_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00216\u2010012\u20106197\u2010y"},{"key":"e_1_2_17_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharma.2021.06.003"},{"key":"e_1_2_17_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/chromsci\/bmab030"},{"key":"e_1_2_17_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0021\u20109673(04)01152\u20105"},{"key":"e_1_2_17_26_1","unstructured":"International Council for Harmonization.2022a. \u201cValidation of Analytical Procedures Q2(R2).\u201d Geneva Switzerland."},{"key":"e_1_2_17_27_1","unstructured":"International Council for Harmonization.2022b. \u201cAnalytical Procedure Development Q14.\u201d Geneva Switzerland."},{"key":"e_1_2_17_28_1","unstructured":"International Council for Harmonization.2025. \u201cStability Testing of New Drug Substances and Products Q1A(R2).\u201d"},{"key":"e_1_2_17_29_1","doi-asserted-by":"publisher","DOI":"10.52711\/0974\u2010360X.2021.01011"},{"key":"e_1_2_17_30_1","doi-asserted-by":"publisher","DOI":"10.5958\/2231\u20105675.2020.00021.6"},{"key":"e_1_2_17_31_1","doi-asserted-by":"publisher","DOI":"10.22159\/ajpcr.2022.v15i3.42117"},{"key":"e_1_2_17_32_1","doi-asserted-by":"publisher","DOI":"10.1007\/978\u20101\u201060327\u2010043\u20104_2"},{"key":"e_1_2_17_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trac.2013.05.008"},{"key":"e_1_2_17_34_1","doi-asserted-by":"publisher","DOI":"10.1098\/rsos.220215"},{"key":"e_1_2_17_35_1","volume-title":"Sample Preparation in Chromatography","author":"Moldoveanu S. C.","year":"2002"},{"key":"e_1_2_17_36_1","doi-asserted-by":"publisher","DOI":"10.52711\/2231\u20105675.2025.00007"},{"key":"e_1_2_17_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0021\u20109673(01)01009\u20103"},{"key":"e_1_2_17_38_1","doi-asserted-by":"publisher","DOI":"10.25258\/ijpqa.14.4.5"},{"key":"e_1_2_17_39_1","doi-asserted-by":"publisher","DOI":"10.1201\/noe0824727857\u2010254"},{"key":"e_1_2_17_40_1","doi-asserted-by":"publisher","DOI":"10.9734\/jpri\/2021\/v33i59a34326"},{"key":"e_1_2_17_41_1","doi-asserted-by":"publisher","DOI":"10.1186\/s43094\u2010021\u201000332\u20101"},{"key":"e_1_2_17_42_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.70235"},{"key":"e_1_2_17_43_1","doi-asserted-by":"publisher","DOI":"10.1155\/2015\/868727"},{"key":"e_1_2_17_44_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.70155"},{"issue":"2","key":"e_1_2_17_45_1","first-page":"1138","article-title":"Development of a Stability\u2010Indicating RP\u2010HPLC Method for the Simultaneous Estimation of Metformin, Teneligliptin, and Dapagliflozin in Bulk and Combined Dosage Form","volume":"16","author":"Ponnusamy K.","year":"2026","journal-title":"Journal of Chemical Health Risks"},{"key":"e_1_2_17_46_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.talanta.2021.123046"},{"key":"e_1_2_17_47_1","doi-asserted-by":"publisher","DOI":"10.1333\/s00897242996a"},{"key":"e_1_2_17_48_1","doi-asserted-by":"publisher","DOI":"10.7324\/JAPS.2023.136050"},{"key":"e_1_2_17_49_1","doi-asserted-by":"publisher","DOI":"10.5530\/ijper.56.4s.213"},{"key":"e_1_2_17_50_1","doi-asserted-by":"publisher","DOI":"10.5530\/ijper.57.2.69"},{"key":"e_1_2_17_51_1","first-page":"363","volume-title":"Essentials in Modern HPLC Separations","author":"Serban C.","year":"2013"},{"key":"e_1_2_17_52_1","doi-asserted-by":"publisher","DOI":"10.1080\/10826076.2023.2284721"},{"key":"e_1_2_17_53_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13065\u2010025\u201001620\u20100"},{"key":"e_1_2_17_54_1","volume-title":"Introduction to Modern Liquid Chromatography","author":"Snyder L. R.","year":"2011"},{"key":"e_1_2_17_55_1","doi-asserted-by":"publisher","DOI":"10.54037\/WJPS.2022.100905"},{"key":"e_1_2_17_56_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpan.2026.03.007"},{"key":"e_1_2_17_57_1","doi-asserted-by":"publisher","DOI":"10.56530\/lcgc.int.op2777i2"},{"key":"e_1_2_17_58_1","doi-asserted-by":"publisher","DOI":"10.56530\/lcgc.int.ug8880n3"},{"key":"e_1_2_17_59_1","doi-asserted-by":"publisher","DOI":"10.9734\/jpri\/2021\/v33i61b35495"},{"issue":"8","key":"e_1_2_17_60_1","first-page":"5927","article-title":"Method Development of Metformin, Saxagliptin and Dapagliflozin in Marketed Formulations by HPLC","volume":"6","author":"Suman S. S.","year":"2022","journal-title":"International Journal of Health Sciences"},{"key":"e_1_2_17_61_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinbiochem.2004.11.007"},{"key":"e_1_2_17_62_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021\u20109673(02)00205\u20104"},{"key":"e_1_2_17_63_1","doi-asserted-by":"publisher","DOI":"10.22159\/ijap.2022v14i2.43626"},{"key":"e_1_2_17_64_1","volume-title":"General Chapter <1220> Analytical Procedure Life Cycle","author":"United States Pharmacopeia","year":"2022"},{"key":"e_1_2_17_65_1","doi-asserted-by":"publisher","DOI":"10.1081\/jlc\u2010200052969"},{"key":"e_1_2_17_66_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5019"},{"key":"e_1_2_17_67_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5384"},{"key":"e_1_2_17_68_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248\u2010022\u201000685\u20102"},{"key":"e_1_2_17_69_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-323-95292-7.00016-5"},{"key":"e_1_2_17_70_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0021\u20109673(01)91570\u20105"},{"key":"e_1_2_17_71_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202300571"},{"issue":"7","key":"e_1_2_17_72_1","first-page":"682","article-title":"Key Factors in Sample Diluent Selection for HPLC Assays of Active Pharmaceutical Ingredients","volume":"23","author":"Wrezel P. W.","year":"2005","journal-title":"LC\u2010GC North America"},{"key":"e_1_2_17_73_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.70197"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70617","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bmc.70617","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70617","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T12:13:54Z","timestamp":1791980034000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70617"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,5]]},"references-count":72,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2026,11]]}},"alternative-id":["10.1002\/bmc.70617"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70617","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,5]]},"assertion":[{"value":"2026-07-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-31","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-05","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70617"}}