{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T12:52:11Z","timestamp":1760014331059,"version":"3.41.2"},"reference-count":17,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2024,5,14]],"date-time":"2024-05-14T00:00:00Z","timestamp":1715644800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>In the present work, new chiral stationary phase high-performance liquid chromatography (CSP-HPLC) method was established and validated for the quantification of pomalidomide (PMD) enantiomers in human plasma. The chromatographic enantiomeric separation was achieved on a Daicel-CSP, Chiralpack IA 4.6\u2009\u00d7\u2009250\u00a0mm, 5\u00a0\u03bcm; because of its advantages of high degree of retention, high resolution capacity, better reproducibility, ability to produce lower back pressure and low degree of tailing. The mobile phase was maintained as methanol: glacial acetic acid (499.50\u00a0ml:50\u00a0\u03bcL). Ultraviolet wavelength for detection was 220\u00a0nm. PMD enantiomer-I and enantiomer-II were separated at 8.83 and 15.34\u00a0min, respectively. Limit of detection and limit of quantification for each enantiomer and the calibration curve of standard PMD was linear in range between 10\u20135,000\u00a0ng\u00a0mL\u22121. The method was validated according to The International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH(Q2R1)) specific guidelines. We found no interference peak with PMD chromatogram obtained. This is a simple, reliable and specific method for detection and quantification of enantiomer of PMD in human plasma sample.<\/jats:p>","DOI":"10.1093\/chromsci\/bmae026","type":"journal-article","created":{"date-parts":[[2024,5,15]],"date-time":"2024-05-15T07:41:18Z","timestamp":1715758878000},"source":"Crossref","is-referenced-by-count":1,"title":["A Validated Chiral Chromatography Method for Enantiomeric Separation of Pomalidomide in Human Plasma"],"prefix":"10.1093","author":[{"given":"Gyan","family":"Vardhan","sequence":"first","affiliation":[{"name":"Department of Pharmacology, All India Institute of Medical Sciences , Rishikesh, Dehradun-249203, Uttarakhand, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vikas","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, All India Institute of Medical Sciences , Bathinda-151001, Punjab, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Puran Lal","family":"Sahu","sequence":"additional","affiliation":[{"name":"National Dope Testing Laboratory , JLN Stadium-G.10, New Delhi, 110003, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anuj","family":"Prakash","sequence":"additional","affiliation":[{"name":"Analytical Division, Indian Pharmacopeia Commission , Ghaziabad 201002, UP, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ramasare","family":"Prasad","sequence":"additional","affiliation":[{"name":"Department of Biotechnology, Indian Institute of Technology , Roorkee-247667, Uttarakhand India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shailendra","family":"Handu","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, All India Institute of Medical Sciences , Rishikesh, Dehradun-249203, Uttarakhand, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uttam Kumar","family":"Nath","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology and Hematology, All India Institute of Medical Sciences , Rishikesh-249203, Dehradun, Uttarakhand, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Puneet","family":"Dhamija","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, All India Institute of Medical Sciences , Rishikesh, Dehradun-249203, Uttarakhand, India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,5,14]]},"reference":[{"key":"2024051506143788000_ref1","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1038\/leu.2009.236","article-title":"Mechanism of action of immunomodulatory drugs (IMiDS) in multiple myeloma","volume":"24","author":"Quach","year":"2010","journal-title":"Leukemia"},{"key":"2024051506143788000_ref2","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1002\/ajh.21610","article-title":"Pomalidomide: a new IMiD with remarkable activity in both multiple myeloma and myelofibrosis","volume":"85","author":"Lacy","year":"2010","journal-title":"American Journal of Hematology"},{"key":"2024051506143788000_ref3","doi-asserted-by":"crossref","first-page":"4563","DOI":"10.1200\/JCO.2008.21.7356","article-title":"Pomalidomide is active in the treatment of anemia associated with myelofibrosis","volume":"27","author":"Tefferi","year":"2009","journal-title":"Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology"},{"key":"2024051506143788000_ref4","doi-asserted-by":"crossref","first-page":"489","DOI":"10.1007\/s00280-012-2040-6","article-title":"Absorption, metabolism and excretion of [14C]pomalidomide in humans following oral administration","volume":"71","author":"Hoffmann","year":"2013","journal-title":"Cancer Chemotherapy and Pharmacology"},{"key":"2024051506143788000_ref5","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1016\/j.jpba.2013.08.036","article-title":"Sensitive liquid chromatography\/mass spectrometry methods for quantification of pomalidomide in mouse plasma and brain tissue","volume":"88","author":"Jiang","year":"2014","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"key":"2024051506143788000_ref6","first-page":"70","article-title":"Stereochemistry in drug action","volume":"5","author":"McConathy","year":"2003","journal-title":"Prim Care Companion Journal of Clinical Psychiatry"},{"key":"2024051506143788000_ref7","doi-asserted-by":"crossref","first-page":"e07581","DOI":"10.1016\/j.heliyon.2021.e07581","article-title":"Inclusion complexation of the anticancer drug pomalidomide with cyclodextrins: fast dissolution and improved solubility","volume":"7","author":"Szab\u00f3","year":"2021","journal-title":"Heliyon"},{"key":"2024051506143788000_ref8","doi-asserted-by":"crossref","first-page":"14778","DOI":"10.1038\/s41598-023-41941-5","article-title":"Enantioseparation and molecular docking study of selected chiral pharmaceuticals on a commercialized phenylcarbamate-\u03b2-cyclodextrin column using polar organic mode","volume":"13","author":"Dob\u00f3","year":"2023","journal-title":"Scientific Reports"},{"issue":"2","key":"2024051506143788000_ref9","doi-asserted-by":"crossref","DOI":"10.1002\/chir.23520","article-title":"Development and validation of a novel chiral chromatographic method for separation of lenalidomide enantiomers in human plasma","volume":"35","author":"Vardhan","year":"2023","journal-title":"Chirality"},{"year":"2023","author":"ECA Academy","key":"2024051506143788000_ref10"},{"key":"2024051506143788000_ref11","doi-asserted-by":"crossref","first-page":"185","DOI":"10.4103\/0976-500X.162004","article-title":"International conference on harmonization of technical requirements for registration of pharmaceuticals for human use","volume":"6","author":"Singh","year":"2015","journal-title":"Journal of Pharmacology and Pharmacotherapeutics"},{"year":"2023","author":"New Drug Development","key":"2024051506143788000_ref12"},{"key":"2024051506143788000_ref13","doi-asserted-by":"crossref","first-page":"2941","DOI":"10.1002\/jssc.201600354","article-title":"Liquid chromatography with mass spectrometry enantioseparation of pomalidomide on cyclodextrin-bonded chiral stationary phases and the elucidation of the chiral recognition mechanisms by NMR spectroscopy and molecular modeling","volume":"39","author":"Szab\u00f3","year":"2016","journal-title":"Journal of Separation Science"},{"key":"2024051506143788000_ref14","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1002\/chir.22563","article-title":"Chiral separation of uncharged pomalidomide enantiomers using carboxymethyl-\u03b2-cyclodextrin: a validated capillary electrophoretic method","volume":"28","author":"Szab\u00f3","year":"2016","journal-title":"Chirality"},{"key":"2024051506143788000_ref15","doi-asserted-by":"crossref","first-page":"111","DOI":"10.3390\/molecules27010111","article-title":"Comparative chiral separation of thalidomide class of drugs using polysaccharide-type stationary phases with emphasis on elution order and hysteresis in polar organic mode","volume":"27","author":"Foroughbakhshfasaei","year":"2021","journal-title":"Molecules"},{"key":"2024051506143788000_ref16","doi-asserted-by":"crossref","first-page":"730","DOI":"10.1093\/chromsci\/bmv247","article-title":"A validated stability-indicating and stereoselective HPLC method for the determination of lenalidomide enantiomers in bulk form and capsules","volume":"54","author":"Alzoman","year":"2016","journal-title":"Journal of Chromatographic Science"},{"key":"2024051506143788000_ref17","doi-asserted-by":"crossref","first-page":"1198","DOI":"10.1182\/blood-2017-05-782961","article-title":"Pomalidomide, bortezomib, and dexamethasone for patients with relapsed lenalidomide-refractory multiple myeloma","volume":"130","author":"Paludo","year":"2017","journal-title":"Blood"}],"container-title":["Journal of Chromatographic Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/chromsci\/advance-article-pdf\/doi\/10.1093\/chromsci\/bmae026\/57655128\/bmae026.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/chromsci\/advance-article-pdf\/doi\/10.1093\/chromsci\/bmae026\/57655128\/bmae026.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,15]],"date-time":"2024-05-15T07:41:26Z","timestamp":1715758886000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/chromsci\/advance-article\/doi\/10.1093\/chromsci\/bmae026\/7672962"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,14]]},"references-count":17,"URL":"https:\/\/doi.org\/10.1093\/chromsci\/bmae026","relation":{},"ISSN":["0021-9665","1945-239X"],"issn-type":[{"type":"print","value":"0021-9665"},{"type":"electronic","value":"1945-239X"}],"subject":[],"published":{"date-parts":[[2024,5,14]]},"article-number":"bmae026"}}