{"id":"https://openalex.org/W7204273577","doi":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079","title":"ANALYTICAL QUALITY BY DESIGN (AQBD)-BASED DEVELOPMENT AND VALIDATION OF A ROBUST RP-HPLC METHOD FOR THE QUANTITATIVE ESTIMATION OF EMPAGLIFLOZIN IN PHARMACEUTICAL DOSAGE FORMS","display_name":"ANALYTICAL QUALITY BY DESIGN (AQBD)-BASED DEVELOPMENT AND VALIDATION OF A ROBUST RP-HPLC METHOD FOR THE QUANTITATIVE ESTIMATION OF EMPAGLIFLOZIN IN PHARMACEUTICAL DOSAGE FORMS","publication_year":2026,"publication_date":"2026-04-30","ids":{"openalex":"https://openalex.org/W7204273577","doi":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079"},"language":"en","primary_location":{"id":"doi:10.29121/granthaalayah.v14.i6.2026.7079","doi":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079","is_oa":true,"landing_page_url":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079","pdf_url":null,"source":{"id":"https://openalex.org/S4210201586","display_name":"International Journal of Research -GRANTHAALAYAH","issn_l":"2350-0530","issn":["2350-0530","2394-3629"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":"https://openalex.org/P4322614449","host_organization_name":"Granthaalayah Publications and Printers","host_organization_lineage":["https://openalex.org/P4322614449"],"host_organization_lineage_names":["Granthaalayah Publications and Printers"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Research -GRANTHAALAYAH","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5148280776","display_name":"Aabhash Singh","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I15517640","display_name":"Shri Venkateshwara University","ror":"https://ror.org/00xh8va68","country_code":"IN","type":"education","lineage":["https://openalex.org/I15517640"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Aabhash Singh","raw_affiliation_strings":["School of Pharmaceutical Sciences, Shri Venkateshwara University, Gajraula 244236, Amroha, Uttar Pradesh, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"School of Pharmaceutical Sciences, Shri Venkateshwara University, Gajraula 244236, Amroha, Uttar Pradesh, India","institution_ids":["https://openalex.org/I15517640"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5120342593","display_name":"Anjali Bhardwaj","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I15517640","display_name":"Shri Venkateshwara University","ror":"https://ror.org/00xh8va68","country_code":"IN","type":"education","lineage":["https://openalex.org/I15517640"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Anjali Bhardwaj","raw_affiliation_strings":["College of Pharmacy, Shri Venkateshwara University, Gajraula 244236, Amroha, Uttar Pradesh, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"College of Pharmacy, Shri Venkateshwara University, Gajraula 244236, Amroha, Uttar Pradesh, India","institution_ids":["https://openalex.org/I15517640"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5025211818","display_name":"Omprakash Goshain","orcid":"https://orcid.org/0000-0002-9298-0696","observed_orcids":["https://orcid.org/0000-0002-9298-0696"]},"institutions":[{"id":"https://openalex.org/I15517640","display_name":"Shri Venkateshwara University","ror":"https://ror.org/00xh8va68","country_code":"IN","type":"education","lineage":["https://openalex.org/I15517640"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Omprakash Goshain","raw_affiliation_strings":["School of Pharmacy, Shri Venkateshwara University, Gajraula 244236, Amroha, Uttar Pradesh, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"School of Pharmacy, Shri Venkateshwara University, Gajraula 244236, Amroha, Uttar Pradesh, India","institution_ids":["https://openalex.org/I15517640"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I15517640"],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"14","issue":"4","first_page":"134","last_page":"145"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":1.0,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":1.0,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T10908","display_name":"Analytical Chemistry and Chromatography","score":0.0,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/empagliflozin","display_name":"empagliflozin","score":0.9990000128746033},{"id":"https://openalex.org/keywords/analytical-quality-by-design","display_name":"analytical quality by design","score":0.9419999718666077},{"id":"https://openalex.org/keywords/rp-hplc-method-development","display_name":"RP-HPLC method development","score":0.9440000057220459},{"id":"https://openalex.org/keywords/method-validation","display_name":"method validation","score":0.7680000066757202},{"id":"https://openalex.org/keywords/sglt2-inhibitors","display_name":"SGLT2 inhibitors","score":0.8130000233650208},{"id":"https://openalex.org/keywords/dosage-forms","display_name":"pharmaceutical dosage forms","score":0.8569999933242798},{"id":"https://openalex.org/keywords/quality-control","display_name":"quality control","score":0.7059999704360962},{"id":"https://openalex.org/keywords/methodological-robustness","display_name":"method robustness","score":0.5669999718666077},{"id":"https://openalex.org/keywords/experimental-design","display_name":"experimental design","score":0.6420000195503235},{"id":"https://openalex.org/keywords/response-surface-methodology","display_name":"response surface methodology","score":0.8659999966621399},{"id":"https://openalex.org/keywords/failure-mode-and-effects-analysis","display_name":"failure mode and effects analysis","score":0.8939999938011169},{"id":"https://openalex.org/keywords/analytical-target-profile","display_name":"analytical target profile","score":0.6549999713897705},{"id":"https://openalex.org/keywords/method-operable-design-region","display_name":"method operable design region","score":0.828000009059906},{"id":"https://openalex.org/keywords/type-2-diabetes","display_name":"type 2 diabetes","score":0.7609999775886536}],"concepts":[{"id":"https://openalex.org/C2775887513","wikidata":"https://www.wikidata.org/wiki/Q5373824","display_name":"Empagliflozin","level":4,"score":0.8600999712944031},{"id":"https://openalex.org/C204320433","wikidata":"https://www.wikidata.org/wiki/Q7268772","display_name":"Quality by Design","level":3,"score":0.847599983215332},{"id":"https://openalex.org/C63479239","wikidata":"https://www.wikidata.org/wiki/Q7353546","display_name":"Robustness (evolution)","level":3,"score":0.6718999743461609},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4684000015258789},{"id":"https://openalex.org/C77281830","wikidata":"https://www.wikidata.org/wiki/Q718608","display_name":"Dosage form","level":2,"score":0.421999990940094},{"id":"https://openalex.org/C2780092901","wikidata":"https://www.wikidata.org/wiki/Q3433612","display_name":"Correlation coefficient","level":2,"score":0.41940000653266907},{"id":"https://openalex.org/C165838908","wikidata":"https://www.wikidata.org/wiki/Q736777","display_name":"Calibration","level":2,"score":0.4083999991416931},{"id":"https://openalex.org/C34559072","wikidata":"https://www.wikidata.org/wiki/Q2334061","display_name":"Design of experiments","level":2,"score":0.4016999900341034},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.35989999771118164},{"id":"https://openalex.org/C77170095","wikidata":"https://www.wikidata.org/wiki/Q1753188","display_name":"Linearity","level":2,"score":0.34040001034736633},{"id":"https://openalex.org/C2780449318","wikidata":"https://www.wikidata.org/wiki/Q18344773","display_name":"Critical quality attributes","level":3,"score":0.3172000050544739},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.3089999854564667},{"id":"https://openalex.org/C106186310","wikidata":"https://www.wikidata.org/wiki/Q1437823","display_name":"Pharmaceutical formulation","level":2,"score":0.2775999903678894},{"id":"https://openalex.org/C202799725","wikidata":"https://www.wikidata.org/wiki/Q272035","display_name":"Accuracy and precision","level":2,"score":0.2646999955177307}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.29121/granthaalayah.v14.i6.2026.7079","doi":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079","is_oa":true,"landing_page_url":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079","pdf_url":null,"source":{"id":"https://openalex.org/S4210201586","display_name":"International Journal of Research -GRANTHAALAYAH","issn_l":"2350-0530","issn":["2350-0530","2394-3629"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":"https://openalex.org/P4322614449","host_organization_name":"Granthaalayah Publications and Printers","host_organization_lineage":["https://openalex.org/P4322614449"],"host_organization_lineage_names":["Granthaalayah Publications and Printers"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Research -GRANTHAALAYAH","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.29121/granthaalayah.v14.i6.2026.7079","doi":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079","is_oa":true,"landing_page_url":"https://doi.org/10.29121/granthaalayah.v14.i6.2026.7079","pdf_url":null,"source":{"id":"https://openalex.org/S4210201586","display_name":"International Journal of Research -GRANTHAALAYAH","issn_l":"2350-0530","issn":["2350-0530","2394-3629"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":"https://openalex.org/P4322614449","host_organization_name":"Granthaalayah Publications and Printers","host_organization_lineage":["https://openalex.org/P4322614449"],"host_organization_lineage_names":["Granthaalayah Publications and Printers"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Research -GRANTHAALAYAH","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.8371999859809875,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":9,"referenced_works":["https://openalex.org/W1557141846","https://openalex.org/W2029584965","https://openalex.org/W2048058024","https://openalex.org/W2110262408","https://openalex.org/W2146264128","https://openalex.org/W2478454999","https://openalex.org/W2484521294","https://openalex.org/W2971465266","https://openalex.org/W3008845456"],"related_works":["https://openalex.org/W7164377423","https://openalex.org/W7164174597","https://openalex.org/W4415071520","https://openalex.org/W7117450730","https://openalex.org/W4415264893","https://openalex.org/W4415266450","https://openalex.org/W7221791842","https://openalex.org/W7206159363","https://openalex.org/W4413175638","https://openalex.org/W7155604160"],"abstract_inverted_index":{"Background:":[0],"Empagliflozin,":[1],"a":[2,34,55,88,250],"selective":[3],"sodium-glucose":[4],"co-transporter-2":[5],"(SGLT2)":[6],"inhibitor,":[7],"is":[8,41,269],"widely":[9],"prescribed":[10],"for":[11,43,97,276],"the":[12,98,209],"management":[13,68,297],"of":[14,63,101,153,249,280,287],"type":[15],"2":[16],"diabetes":[17],"mellitus":[18],"and":[19,24,37,66,76,86,106,132,144,147,186,201,220,274,295],"has":[20,52],"demonstrated":[21,194],"significant":[22],"cardiovascular":[23],"renal":[25],"protective":[26],"effects.":[27],"Owing":[28],"to":[29,69,84,162,171],"its":[30],"extensive":[31],"clinical":[32],"use,":[33],"robust,":[35,272],"reliable,":[36],"stability-indicating":[38],"analytical":[39,71,236,258,302],"method":[40,96,118,193,242,268,292],"essential":[42],"routine":[44,261,277],"quality":[45,278],"control.":[46],"Analytical":[47,111],"Quality":[48],"by":[49,175],"Design":[50,62,152,253],"(AQbD)":[51],"emerged":[53],"as":[54],"systematic":[56],"approach":[57,155],"that":[58,231],"integrates":[59],"risk":[60,139],"assessment,":[61],"Experiments":[64,154],"(DoE),":[65],"lifecycle":[67,296],"develop":[70,85],"procedures":[72],"with":[73,213,223,299],"enhanced":[74],"robustness":[75,228],"regulatory":[77],"flexibility.":[78],"(Objective:":[79],"The":[80,110,190,244,264],"present":[81],"study":[82],"aimed":[83],"validate":[87],"robust":[89],"AQbD-based":[90],"reverse-phase":[91],"high-performance":[92],"liquid":[93],"chromatographic":[94,164,192],"(RP-HPLC)":[95],"quantitative":[99],"estimation":[100],"empagliflozin":[102,281],"in":[103,235,282],"bulk":[104],"drug":[105],"pharmaceutical":[107,283],"dosage":[108,284],"forms.Methods:":[109],"Target":[112],"Profile":[113],"(ATP)":[114],"was":[115,160,168],"established":[116],"before":[117],"development.":[119],"Critical":[120],"Method":[121,166,251],"Parameters":[122],"(CMPs),":[123],"including":[124],"mobile":[125],"phase":[126],"composition,":[127],"flow":[128],"rate,":[129],"column":[130],"temperature,":[131],"detection":[133,182],"wavelength,":[134],"were":[135],"identified":[136],"through":[137],"preliminary":[138],"assessment":[140],"using":[141],"Ishikawa":[142],"diagrams":[143],"Failure":[145],"Mode":[146],"Effects":[148],"Analysis":[149],"(FMEA).":[150],"A":[151],"employing":[156],"response":[157],"surface":[158],"methodology":[159],"used":[161],"optimize":[163],"conditions.":[165],"validation":[167],"performed":[169],"according":[170],"ICH":[172,224],"Q2(R2)":[173],"recommendations":[174],"evaluating":[176],"specificity,":[177],"linearity,":[178],"accuracy,":[179],"precision,":[180],"robustness,":[181,294],"limit,":[183,185],"quantification":[184],"system":[187],"suitability.":[188],"Results:":[189],"optimized":[191],"excellent":[195,206],"peak":[196],"symmetry,":[197],"acceptable":[198],"retention":[199],"time,":[200],"satisfactory":[202],"resolution.":[203],"Calibration":[204],"exhibited":[205],"linearity":[207],"across":[208],"selected":[210],"concentration":[211],"range":[212],"correlation":[214],"coefficient":[215],"greater":[216],"than":[217],"0.999.":[218],"Accuracy":[219],"precision":[221],"complied":[222],"acceptance":[225],"criteria,":[226],"while":[227],"studies":[229],"confirmed":[230],"small":[232],"deliberate":[233],"variations":[234],"parameters":[237],"did":[238],"not":[239],"significantly":[240,290],"influence":[241],"performance.":[243],"AQbD":[245,288],"strategy":[246],"enabled":[247],"establishment":[248],"Operable":[252],"Region":[254],"(MODR),":[255],"ensuring":[256],"reliable":[257],"performance":[259],"during":[260],"analysis.":[262],"Conclusion:":[263],"proposed":[265],"AQbD-assisted":[266],"RP-HPLC":[267],"accurate,":[270],"precise,":[271],"economical,":[273],"suitable":[275],"control":[279],"forms.":[285],"Integration":[286],"principles":[289],"improved":[291],"understanding,":[293],"compared":[298],"conventional":[300],"trial-and-error":[301],"development":[303],"approaches.":[304]},"counts_by_year":[],"updated_date":"2026-10-28T10:33:24.094632","created_date":"2026-08-27T00:00:00"}