{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T04:09:03Z","timestamp":1784088543860,"version":"3.55.0"},"reference-count":15,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:00:00Z","timestamp":1781568000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:00:00Z","timestamp":1781568000000},"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":["Chirality"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Niraparib is a potent, orally bioavailable inhibitor of poly (ADP\u2010ribose) polymerase (PARP) enzymes, specifically targeting PARP\u20101 and PARP\u20102 to induce selective cytotoxicity in malignancies by disrupting DNA repair mechanisms. Given that the S\u2010niraparib exhibits significantly higher pharmacological activity than the R\u2010isomer, the development of a precise analytical technique to ensure enantiomeric purity is a critical requirement for pharmaceutical quality control. This study details the development and validation of a stability\u2010indicating chiral high\u2010performance liquid chromatography (HPLC) method for the quantitative assessment of enantiomeric purity content. Separation was successfully achieved using a Chiralpak AS\u2010H 250\u2009\u00d7\u20094.6\u2009mm, 5\u2009\u03bcm column under isocratic conditions with a mobile phase consisting of n\u2010hexane, ethanol, methanol, and diethylamine in a 750:100:150:1.0 (v\/v\/v\/v) ratio. The system was operated at a flow rate of 0.7\u2009mL\/min and a controlled column temperature of 40\u00b0C, with detection monitored via a UV\/visible detector at 240\u2009nm. The method was rigorously validated in accordance with ICH Q2(R2) guidelines, demonstrating specificity, accuracy, and precision. A resolution factor of greater than 2.0 was maintained between niraparib and its isomer. Analytical sensitivity was established through the determination of the limit of detection (LOD) and limit of quantitation (LOQ) using signal\u2010to\u2010noise ratios of 3 and 10, respectively, with a 1\u2009mg\/mL sample concentration and a 10\u2009\u03bcL injection volume. Calibration curves proved linear over the studied range, confirming the method's reliability. The results indicate that this stability\u2010indicating approach is highly effective for routine in\u2010process quality control, batch release testing, and long\u2010term stability monitoring of niraparib drug substances.<\/jats:p>","DOI":"10.1002\/chir.70110","type":"journal-article","created":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T05:45:31Z","timestamp":1781675131000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Novel, Robust, and Isocratic HPLC\u2010UV Method for the Comprehensive Determination of Enantiomeric Impurity (R\u2010Isomer) in Niraparib Drug Substance"],"prefix":"10.1002","volume":"38","author":[{"given":"Praveen Kumar","family":"Kondaveti","sequence":"first","affiliation":[{"name":"Department of Engineering Chemistry Andhra University  Visakhapatnam India"},{"name":"Dr Reddy's Laboratories IPDO, API AR&amp;D Bachupally  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Douglas","sequence":"additional","affiliation":[{"name":"Department of Engineering Chemistry Andhra University  Visakhapatnam India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akula","family":"Raghunadh","sequence":"additional","affiliation":[{"name":"Dr Reddy's Laboratories IPDO, API AR&amp;D Bachupally  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Kalyanaraman","sequence":"additional","affiliation":[{"name":"Dr Reddy's Laboratories IPDO, API AR&amp;D Bachupally  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,16]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Wikipedia Contributors \u201cNiraparib \u201d Wikipedia (2006) accessed January 27 2026 https:\/\/en.wikipedia.org\/wiki\/Niraparib."},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0165-022X(02)00124-0"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199600525-00003"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9673(00)00532-X"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.1986.150"},{"key":"e_1_2_9_7_1","unstructured":"Food and Drug Administration \u201cFDA Policy Statement for Development of New Stereoisomeric Drugs \u201d (1992) U.S. Government Printing Office."},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/jccs.199800088"},{"key":"e_1_2_9_9_1","volume-title":"Proceedings of the International Conference on Harmonization","author":"Guideline, ICH Harmonised Tripartite","year":"2006"},{"key":"e_1_2_9_10_1","volume-title":"Proceedings of the International Conference on Harmonization","author":"International Council for Harmonisation (ICH)","year":"2023"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9673(02)01536-4"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1021\/ja00330a057"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02687754"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9673(01)83736-5"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1246\/cl.1990.909"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9673(01)01573-4"}],"container-title":["Chirality"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/chir.70110","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/chir.70110","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/chir.70110","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T03:56:37Z","timestamp":1784087797000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/chir.70110"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,16]]},"references-count":15,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1002\/chir.70110"],"URL":"https:\/\/doi.org\/10.1002\/chir.70110","archive":["Portico"],"relation":{},"ISSN":["0899-0042","1520-636X"],"issn-type":[{"value":"0899-0042","type":"print"},{"value":"1520-636X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,16]]},"assertion":[{"value":"2026-02-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70110"}}