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The degradation and process impurities in EP and ChP were identified in addition to budesonide and formoterol fumarate. As of yet, no one has reported all impurities using a single method. It is a unique research because it analyzes APSD (Aerodynamic Particle Size Distribution), DDU (Delivered Dose Uniformity), BU (Blend Uniformity), Assay, and cleaning test samples. It enhances the quality of medicine and separates all organic impurities and isomers through a suitable stationary phase (YMC\u2010Pack Pro C18, 150\u2009\u00d7\u20094.6\u2009mm\u2009\u00d7\u20093\u2009\u03bcm). We optimized the chromatographic conditions: Injection volume was 20\u2009\u03bcL, and flow rate was 1.0\u2009mL\/min. The wavelength was optimized at 220\u2009nm. After experimental and validation results. An example is A, which contains sodium dihydrogen orthophosphate monohydrate, sodium 1\u2010decane sulfonate, adjusted pH\u20093.0, and acetonitrile at a ratio of 80:20 (v\/v), and B, which contains pH\u20093.0 buffer and acetonitrile at a ratio of 20:80 (v\/v) respectively. In addition to being optimized, the test method was validated according to ICH Q2(R2).<\/jats:p>","DOI":"10.1002\/bmc.6062","type":"journal-article","created":{"date-parts":[[2025,1,10]],"date-time":"2025-01-10T04:05:59Z","timestamp":1736481959000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Unique Research for Developing a Full Factorial Design Evaluated Liquid Chromatography Technique for Estimating Budesonide and Formoterol Fumarate Dihydrate in the Presence of Specified and Degradation Impurities in Dry Powder Inhalation"],"prefix":"10.1002","volume":"39","author":[{"given":"Lova\u00a0Gani\u00a0Raju","family":"Bandaru","sequence":"first","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to Be University  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0815-9238","authenticated-orcid":false,"given":"Naresh","family":"Konduru","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to Be University  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leela\u00a0Prasad","family":"Kowtharapu","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to Be University  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0390-6505","authenticated-orcid":false,"given":"Rambabu","family":"Gundla","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to Be University  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phani\u00a0Raja","family":"Kanuparthy","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to Be University  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5737-8528","authenticated-orcid":false,"given":"Naresh\u00a0Kumar","family":"Katari","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to Be University  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,1,10]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200010123431502"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0731-7085(03)00425-4"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2020.113729"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2005.11.015"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1134\/S1061934824030031"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2010.08.048"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2020.122512"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arabjc.2015.05.005"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11094-022-02610-5"},{"key":"e_1_2_8_11_1","first-page":"1","article-title":"Development and Validation of new Analytical Methods for the Simultaneous Estimation of Levamisole and Albendazole in Bulk and Tablet Dosage Form by RP\u2010HPLC","volume":"3","author":"Ettaboina S. 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