{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T07:12:55Z","timestamp":1790925175351,"version":"4.1.0"},"reference-count":35,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T00:00:00Z","timestamp":1778976000000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:00:00Z","timestamp":1777593600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Chemistry &amp; Biodiversity"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    The study was designed to establish and validate simple, precise, and economical analytical methods for the quantitative determination of Ranolazine in compliance with International Council for Harmonisation Q2(R2) and M10 bioanalytical validation guidelines. The aim was to ensure accurate estimation in both pharmaceutical formulations and biological samples. Quantification was carried out using reverse phase high\u2010performance liquid chromatography (RP\u2010HPLC) and UV\u2013visible spectrophotometry. Chromatographic separation was performed on a Phenomenex C18 (250\u00a0mm \u00d7 4.6mmID \u00d7 5um) column using a mobile phase composed of methanol and water (45:55, pH adjusted to 5.5 with glacial acetic acid). The system operated under isocratic conditions at a flow rate of 1.2\u00a0mL\/min, with detection at 278\u00a0nm and an injection volume of 20\u00a0\u00b5L. In the spectrophotometric method, ranolazine produced a stable chromogenic complex measurable at the same wavelength. Additionally, a nanoformulation of ranolazine was developed via a microemulsion technique, yielding uniform and stable nanoparticles (\u223c176\u00a0nm). Method validation was performed according to ICH Q2(R2) for analytical parameters such as specificity, linearity, accuracy, precision, robustness, LOD, and LOQ, while bioanalytical validation in plasma followed ICH M10 criteria, including selectivity, recovery, matrix effect, and stability. The methods demonstrated excellent linearity with a correlation coefficient (\n                    <jats:italic>r<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    ) greater than 0.999 across the concentration range of 22\u2013310\u00a0\u00b5g\/mL. Recovery values ranged from 98.9% to 99.85%, and precision was confirmed with RSD values below 2%. LOD and LOQ were found to be 0.019 and 0.060\u00a0\u00b5g\/mL. Application of the RP\u2010HPLC method to tablet analysis showed an assay value of 99.59% for the 500\u00a0mg formulation, confirming accuracy. The nanoformulation exhibited an accurate drug content with an assay value of 99.82% at 80\u00a0\u00b5g\/mL. Furthermore, the extraction efficiency was determined to be 99.56% by liquid\u2013liquid extraction, indicating efficient recovery from biological matrices. The proposed RP\u2010HPLC and chromogenic UV\u2013visible methods were found to be reliable, sensitive, and reproducible for the estimation of Ranolazine. These validated methods are well\u2010suited for routine quality control analysis, stability studies, and bioanalytical applications, including evaluation of advanced drug delivery systems such as nanoformulations.\n                  <\/jats:p>","DOI":"10.1002\/cbdv.202503715","type":"journal-article","created":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T05:46:02Z","timestamp":1779083162000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Validated RP\u2010HPLC and Chromogenic UV Methods for Quantification of Ranolazine in Bulk, Plasma, and Nanoformulation as per ICH Q2(R2) and M10 Guidelines"],"prefix":"10.1002","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9545-937X","authenticated-orcid":false,"given":"Khagga","family":"Bhavya Sri","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis RBVRR Women's College of Pharmacy  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammed","family":"Jeneesha","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis RBVRR Women's College of Pharmacy  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinkala","family":"Pravallika","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis RBVRR Women's College of Pharmacy  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,17]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"Drug Bank Online Ranolazine: Uses Interactions Mechanism of Action https:\/\/go.drugbank.com\/drugs\/DB00243."},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.51847\/Czxl0wYrYr"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2022.112828"},{"key":"e_1_2_12_5_1","first-page":"1215","article-title":"Development and Validation of Ultraviolet\u2010Visible Spectrophotometric Method for Estimation of Rivaroxaban in Spiked Human Plasma","volume":"12","author":"Bhavyasri K.","year":"2020","journal-title":"Journal of Pharmaceutical Sciences and Research"},{"key":"e_1_2_12_6_1","first-page":"2243","article-title":"Bioanalytical Method Development and Validation of Atorvastatin in Human Plasma by UV\u2010Visible Spectrophotometry","volume":"11","author":"Bhavyasri K.","year":"2019","journal-title":"Journal of Pharmaceutical Sciences and Research"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.5530\/jyp.2020.12s.48"},{"key":"e_1_2_12_8_1","first-page":"30","article-title":"Bioanalytical Method Development and Validation of Ranolazine in Human Plasma by LC\u2013MS\/MS","volume":"998","author":"Nagaraju P. N.","year":"2015","journal-title":"Journal of Chromatography B, Analytical Technologies in the Biomedical and Life Sciences"},{"key":"e_1_2_12_9_1","doi-asserted-by":"crossref","unstructured":"K.Bhavyasri C. H.Mounika N.Vallakeerthi andM.Sumakanth (2020) RP\u2010HPLC Method Development and Validation for Determination of Tigecycline in Bulk and Pharmaceutical Dosage Form Unpublished data.","DOI":"10.9734\/jpri\/2021\/v33i39B32204"},{"key":"e_1_2_12_10_1","first-page":"685","article-title":"Development and Validation of Forced Degradation Studies of Raltegravir Using RP\u2010HPLC and Characterization of Degradants by LC\u2010MS\/MS","volume":"7","author":"Bhavyasri K.","year":"2015","journal-title":"Journal of Pharmaceutical Sciences and Research"},{"key":"e_1_2_12_11_1","unstructured":"K.Bhavyasri C. D.Lakshmi andD.Rambabu (2019) Development and Validation of UV\u2010Visible Spectrophotometric Method for Estimation of Moxifloxacin in Human Plasma Unpublished data."},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.51847\/Xc9UhmnyiY"},{"key":"e_1_2_12_13_1","first-page":"116","article-title":"Simultaneous Method Development and Validation of UV\u2010Visible Spectrophotometric Method for Estimation of Darunavir and Ritonavir in Spiked Human Plasma","volume":"11","author":"Bhavyasri K.","year":"2020","journal-title":"Aut Aut Research Journal"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.52711\/0974-360X.2023.00973"},{"issue":"6","key":"e_1_2_12_15_1","first-page":"806","article-title":"Development and Validation of a UV Spectrophotometric Method for the Estimation of Ranolazine in Bulk and Dosage Form","volume":"70","author":"Lakshmi K. S.","year":"2008","journal-title":"Indian Journal of Pharmaceutical Science"},{"key":"e_1_2_12_16_1","unstructured":"ICH M10 Bioanalytical Method Validation: Step 5 Guidance for Industry (International Council for Harmonisation 2023)."},{"key":"e_1_2_12_17_1","first-page":"322","article-title":"A Validated Bioanalytical Method for Quantification of Ziprasidone in Rabbit Plasma by LC\u2010MS\/MS: Application to a Pharmacokinetic Study","volume":"6","author":"Bhavyasri K.","year":"2015","journal-title":"British Journal of Pharmacology"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.51847\/4aAGsEQxu5"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00769-025-01638-w"},{"key":"e_1_2_12_20_1","first-page":"1","article-title":"ICH M10\u2010Based Validation of a Novel Chromogenic Bioanalytical Method for Quantifying Hesperidin in Biological Samples","volume":"59","author":"Bhavya SriK","year":"2025","journal-title":"Indian Journal of Pharmaceutical Education and Research"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41401\u2010024\u201001305\u20109"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2025.1659251"},{"key":"e_1_2_12_23_1","unstructured":"ICH Q2(R2) \u201cValidation of Analytical Procedures: Text and Methodology \u201d(International Council for Harmonisation 2022)."},{"issue":"10","key":"e_1_2_12_24_1","first-page":"812","article-title":"LC\u2013MS\/MS Method for the Quantitation of Ranolazine in Human Plasma: Validation and its Application to a Clinical Pharmacokinetic Study","volume":"19","author":"Ramakrishna N. V. S.","year":"2005","journal-title":"Biomedical Chromatography"},{"issue":"9","key":"e_1_2_12_25_1","first-page":"1132","article-title":"Thakare VM. Bioanalytical Method Development and Validation of Anti\u2010Anginal Drug Ranolazine in Human Plasma by RP\u2010HPLC","volume":"6","author":"Deshmukh N. J.","year":"2017","journal-title":"World Journal of Pharmaceutical Sciences"},{"issue":"6","key":"e_1_2_12_26_1","first-page":"748","article-title":"Ranolazine: A Review of Its Pharmacokinetic and Bioanalytical Aspects","volume":"38","author":"Zhang S.","year":"2016","journal-title":"Therapeutic Drug Monitoring"},{"issue":"3","key":"e_1_2_12_27_1","first-page":"201","article-title":"Spectrophotometric Determination of Drugs Using MBTH as Chromogenic Reagent: A Review","volume":"12","author":"Goyal A.","year":"2017","journal-title":"Eurasian Journal of Analytical Chemistry"},{"issue":"4","key":"e_1_2_12_28_1","first-page":"1778","article-title":"Spectrophotometric Estimation of Ranolazine Using MBTH Reagent in Bulk and Pharmaceutical Formulations","volume":"8","author":"Dhandapani M.","year":"2015","journal-title":"International Journal of ChemTech Research"},{"key":"e_1_2_12_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2023.123871"},{"key":"e_1_2_12_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.microc.2025.115329"},{"issue":"10","key":"e_1_2_12_31_1","first-page":"3851","article-title":"Colorimetric Determination of Ranolazine Using MBTH Reagent in Plasma Samples","volume":"27","author":"Babu P. S.","year":"2015","journal-title":"Asian Journal of Chemistry"},{"issue":"12","key":"e_1_2_12_32_1","first-page":"185","article-title":"Development and Validation of Visible Spectrophotometric Methods for Estimation of Selected Drugs Using Oxidative Coupling Reactions With MBTH","volume":"8","author":"Prasad C. V. N.","year":"2016","journal-title":"International Journal of Pharmacy and Pharmaceutical Sciences"},{"issue":"3","key":"e_1_2_12_33_1","first-page":"221","article-title":"Sensitive Spectrophotometric Determination of Pharmaceutical Compounds Using MBTH and FeCl3 as Chromogenic System","volume":"51","author":"Gowda B. G.","year":"2001","journal-title":"Acta Pharmaceutica"},{"issue":"1","key":"e_1_2_12_34_1","first-page":"S539","article-title":"Spectrophotometric Determination of Pharmaceuticals Through Oxidative Coupling Reactions With MBTH Reagent","volume":"6","author":"Reddy K. R.","year":"2009","journal-title":"E\u2010Journal of Chemistry"},{"key":"e_1_2_12_35_1","first-page":"1298","article-title":"Quantification of Hesperidin in Bulk, Ayurvedic Formulations Including Plant Extracts and Human Plasma Spiked Using Chromogenic Method","volume":"20","author":"Pravallika J.","year":"2024","journal-title":"Nanotechnology Perceptions"},{"key":"e_1_2_12_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2024.112178"}],"container-title":["Chemistry &amp; Biodiversity"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cbdv.202503715","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cbdv.202503715","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cbdv.202503715","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T15:59:12Z","timestamp":1785081552000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/cbdv.202503715"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5]]},"references-count":35,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1002\/cbdv.202503715"],"URL":"https:\/\/doi.org\/10.1002\/cbdv.202503715","archive":["Portico"],"relation":{},"ISSN":["1612-1872","1612-1880"],"issn-type":[{"value":"1612-1872","type":"print"},{"value":"1612-1880","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5]]},"assertion":[{"value":"2025-11-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-10","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e03715"}}