{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T23:27:21Z","timestamp":1788564441950,"version":"build-2803163510"},"reference-count":55,"publisher":"Wiley","issue":"24","license":[{"start":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T00:00:00Z","timestamp":1758499200000},"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":["Rapid Comm Mass Spectrometry"],"published-print":{"date-parts":[[2025,12,30]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hypertension is a major cause of premature death worldwide despite the availability of a number of antihypertensive medication monotherapies. Therefore, several polytherapies have been prescribed, among which the combination of amlodipine with indapamide is often the preferred choice to control blood pressure, especially in the elderly, because of its efficacy and safety. To ensure the quality of this combination drug, a versatile procedure for the simultaneous quantification of components is required. Thus, this study aims to develop a liquid chromatography \u2010\u00a0tandem mass spectrometric procedure and validate according to FDA and EMA guidelines to determine amlodipine and indapamide in human plasma.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A liquid\u2013liquid extraction with\n                      <jats:italic>tert<\/jats:italic>\n                      \u2010butyl methyl ether and ethyl acetate (1:1) was applied to extract the compounds. Amlodipine was ionized with positive electrospray ionization and detected by multiple reaction monitoring mode, while indapamide was ionized with negative electrospray ionization and detected by selected ion monitoring mode. Samples were chromatographically analyzed on a C18 column (150\u2009\u00d7\u20094.6\u2009mm; 3.5\u2009\u03bcm), eluted by the mobile phase of methanol and 0.025% formic acid (90:10, v\/v).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Linearity ranged from 0.29\u2010 to 17.14\u2010ng\/mL amlodipine, from 1.14\u2010 to 68.57\u2010ng\/mL indapamide. The lower limit of quantitation of amlodipine and indapamide is 0.29\u2010 and 1.14\u2010ng\/mL, respectively. The validation using furosemide as an internal standard showed that the specificity, intra\u2010 and interday precision and accuracy, matrix effect, sample carryover, dilution, and stability were in the acceptable range.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The method met validation criteria of US\u2010FDA and EMA guidelines, thereby recommended for application in in\u00a0vivo bioavailability and bioequivalence assessment of fixed\u2010dose combinations of amlodipine with indapamide.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/rcm.10131","type":"journal-article","created":{"date-parts":[[2025,9,23]],"date-time":"2025-09-23T05:16:16Z","timestamp":1758604576000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Establishment and Validation of High\u2010Performance Liquid Chromatography\u2014Tandem Mass Spectrometry for Simultaneous Assessment of Amlodipine and Indapamide in Human Plasma"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9479-403X","authenticated-orcid":false,"given":"Duc Tuan","family":"Nguyen","sequence":"first","affiliation":[{"name":"Department of Analytical Chemistry and Drug Quality Control School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City  Ho Chi Minh City Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-0595-1989","authenticated-orcid":false,"given":"Thu Le Anh","family":"Do","sequence":"additional","affiliation":[{"name":"Nam Can Tho University  Can Tho Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7802-7718","authenticated-orcid":false,"given":"Sil Thanh","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Department of Analytical Chemistry and Drug Quality Control Faculty of Pharmacy, Can Tho University of Medicine and Pharmacy  Can Tho Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5005-9447","authenticated-orcid":false,"given":"Thi Anh Huynh","family":"Huynh","sequence":"additional","affiliation":[{"name":"Department of Health Sciences Can Tho University, College of Natural Sciences  Can Tho Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4359-9335","authenticated-orcid":false,"given":"Vo Thi Kim","family":"Khuyen","sequence":"additional","affiliation":[{"name":"Department of Analytical Chemistry and Drug Quality Control School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City  Ho Chi Minh City Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2148-6436","authenticated-orcid":false,"given":"Tho Vinh Minh Chau","family":"Do","sequence":"additional","affiliation":[{"name":"Department of Analytical Chemistry and Drug Quality Control Faculty of Pharmacy, Can Tho University of Medicine and Pharmacy  Can Tho Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/FJC.0000000000001116"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41581-019-0244-2"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11906-013-0402-z"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/HJH.0b013e3282f0580f"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.HYP.0000103630.72812.10"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31629-0"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.4236\/pp.2013.42027"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.microc.2020.104700"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2012.06.014"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199141030-00009"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.3148"},{"key":"e_1_2_10_13_1","first-page":"379","article-title":"Hypertension in the Very Elderly: Brief Review of Management","volume":"16","author":"Zeglin M. 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