{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T03:57:29Z","timestamp":1791431849939,"version":"4.3.3"},"reference-count":21,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T00:00:00Z","timestamp":1727308800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The present study discusses the development of simple, rapid, specific, precision, accuracy, stability indicating the HPLC method for the analysis of amlodipine besylate and valsartan tablet dosage form. The chromatographic separation was achieved using phosphate buffer with 1% triethyl amine (pH\u00a03.0) as mobile phase\u2010A and mixed Methanol and buffer in the ratio of (65:35)(v\/v) as mobile phase\u2010B. The detection of components was made at 237\u2009nm for amlodipine besylate and valsartan. Analytical techniques should enrich sensitivity and specificity for the estimation of pharmaceutical drug products. Evaluated stress studies under different types of ICH conditions. The optimized HPLC method was validated as per the current ICH guidelines. The validated HPLC method was obtained highly specific with linearity ranging between 25 and 200 \u03bcgmL<jats:sup>\u22121<\/jats:sup> of amlodipine besylate and 40\u2013320 \u03bcgmL<jats:sup>\u22121<\/jats:sup> of valsartan and both components correlation coefficient was &gt; 0.999. The method showed high accuracy more than 97%. In stress studies, amlodipine besylate and valsartan were found to be sensitive to acid stress conditions and oxidation stress conditions. The method was found to be suitable for the quality control of amlodipine besylate and valsartan in the tablet as well as in stability\u2010indicating studies. The method was applied to the analysis of stability samples.<\/jats:p>","DOI":"10.1002\/bmc.6017","type":"journal-article","created":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T21:54:08Z","timestamp":1727387648000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Stability\u2010indicating RP\u2010HPLC method development and validation for the quantification of amlodipine besylate and valsartan tablets in solid oral dosage form"],"prefix":"10.1002","volume":"38","author":[{"given":"Teja","family":"Kamireddy","sequence":"first","affiliation":[{"name":"August Bioservices  1845 Elm Hill Pike Nashville TN 37210 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-6931-1512","authenticated-orcid":false,"given":"Pranitha","family":"Sambu","sequence":"additional","affiliation":[{"name":"Aurex Laboratories Pvt Ltd. Prashanthi nagar, Kukatpally  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8493-0450","authenticated-orcid":false,"given":"Prasanna Kumar","family":"Lankalapalli","sequence":"additional","affiliation":[{"name":"Visual Technologies LLC  5851 Legacy Circle Plano TX 75024 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rama Krishna","family":"Myneni","sequence":"additional","affiliation":[{"name":"Stira pharmaceuticals LLC  161, Dwight place, Fairfield New Jersey 07004 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hareesh","family":"Divadari","sequence":"additional","affiliation":[{"name":"Stira pharmaceuticals LLC  161, Dwight place, Fairfield New Jersey 07004 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,26]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"31","article-title":"Simultaneous determination and stability evaluation of amlodipine besylate and valsartan in rat plasma by RP\u2010HPLC method","volume":"1","author":"Devi R.","year":"2010","journal-title":"International Journal of Biopharmaceutics"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.4236\/ajac.2012.36055"},{"key":"e_1_2_7_4_1","first-page":"34","article-title":"Determination of S\u2010 and R\u2010amlodipine in rat plasma using LC\u2010MS\/MS after Oral administration of S\u2010amlodipine and racemic amlodipine","volume":"2","author":"Hye H.","year":"2011","journal-title":"Mass Spectrometry Letters"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/jaoac\/93.3.882"},{"key":"e_1_2_7_6_1","first-page":"237","article-title":"Validated reverse phase high\u2010performance liquid chromatography method for simultaneous estimation of valsartan potassium and amlodipine Besylate in the tablet dosage form","volume":"5","author":"Maheshwari N.","year":"2013","journal-title":"International Journal of Drug Development and Research"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1021\/acsomega.3c04589"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.microc.2023.109835"},{"key":"e_1_2_7_9_1","first-page":"141","article-title":"RP\u2010HPLC method for simultaneous determination of amlodipine besylate, valsartan, telmisartan, hydrochlorothiazide and chlorthalidone: Application to commercially available drug products","volume":"3","author":"Mhaske R. A.","year":"2012","journal-title":"International Journal of Pharmaceutical Sciences and Research"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.4137\/ACI.S7282"},{"key":"e_1_2_7_11_1","first-page":"1257","article-title":"Stability indicating RP\u2010HPLC method for simultaneous determination of valsartan and amlodipine from their combination drug product","volume":"1","author":"Patel S. B.","year":"2009","journal-title":"International Journal of Chemistry Research"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5626"},{"key":"e_1_2_7_13_1","first-page":"280","article-title":"Stability indicating RP\u2010HPLC method for simultaneous determination of amlodipine besylate and valsartan combination in bulk and commercial dosage forms","volume":"2","author":"Rahul R. N.","year":"2012","journal-title":"Asian Journal of Pharmaceutical Sciences"},{"key":"e_1_2_7_14_1","first-page":"66","article-title":"Simple UV spectrophotometric assay of amlodipine","volume":"1","author":"Safila N.","year":"2014","journal-title":"American Journal of Chemistry and Applications"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.4236\/ajac.2012.36055"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202300760"},{"key":"e_1_2_7_17_1","first-page":"1257","article-title":"Stability indicating RP\u2010HPLC method for simultaneous determination of valsartan and amlodipine from their combination drug product","volume":"1","author":"Snehal B. P.","year":"2009","journal-title":"International Journal of ChemTech Research"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.4236\/ajac.2022.1312036"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5944"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.47363\/JPRSR\/2024(5)156"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.4236\/ajac.2013.41003"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5800"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.6017","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T00:58:43Z","timestamp":1760057923000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.6017"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,26]]},"references-count":21,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1002\/bmc.6017"],"URL":"https:\/\/doi.org\/10.1002\/bmc.6017","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,26]]},"assertion":[{"value":"2024-07-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-26","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e6017"}}