{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T19:03:20Z","timestamp":1788289400844,"version":"build-2803163510"},"reference-count":22,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2016,8,26]],"date-time":"2016-08-26T00:00:00Z","timestamp":1472169600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Chirality"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Besifloxacin is a unique chiral broad\u2010spectrum flouroquinolone used in the treatment of bacterial conjunctivitis. <jats:italic>R<\/jats:italic>\u2010form of besifloxacin hydrochloride shows higher antibacterial activity as compared to the <jats:italic>S\u2010<\/jats:italic>isomer. Therefore, it is necessary to establish chiral purity. To establish chiral purity a high\u2010performance liquid chromatography (HPLC) method for determination of <jats:italic>R<\/jats:italic>\u2010besifloxacin and <jats:italic>S<\/jats:italic>\u2010besifloxacin (BES impurity A) was developed and validated for in\u2010process quality control and stability studies. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD), and lower limit of quantification (LOQ) were determined according to International Council for Harmonization ICH Q2(R1) guidelines. HPLC separation was achieved on Chiralpak AD\u2010H (250 x 4.6\u00a0mm, 5\u00a0\u03bcm) column using <jats:italic>n<\/jats:italic>\u2010heptane: ethanol: ethylenediamine: acetic acid (800:200:0.5:0.5) (v\/v\/v\/v) as the mobile phase in an isocratic elution. The eluents were monitored by UV\/Visible detector at 290\u00a0nm. The resolution between S\u2010isomer and besifloxacin hydrochloride was more than 2.0. Based on a signal\u2010to\u2010noise ratio of 3 and 10 the LOD of besifloxacin was 0.30\u00a0\u03bcg\/mL, while the LOQ was 0.90\u00a0\u03bcg\/mL. The calibration curves were linear in the range of 0.9\u20137.5\u00a0\u03bcg\/mL. Precision of the method was established within the acceptable range. The method was suitable for the quality control enantiomeric impurity in besifloxacin hydrochloride.  <jats:italic>Chirality 28:628\u2013632, 2016<\/jats:italic>. \u00a9 2016 Wiley Periodicals, Inc.<\/jats:p>","DOI":"10.1002\/chir.22626","type":"journal-article","created":{"date-parts":[[2016,8,26]],"date-time":"2016-08-26T15:25:55Z","timestamp":1472225155000},"page":"628-632","source":"Crossref","is-referenced-by-count":10,"title":["Simple Isocratic HPLC Method for Determination of Enantiomeric Impurity in Besifloxacin Hydrochloride"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9948-3150","authenticated-orcid":false,"given":"G. 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