{"id":20681,"date":"2025-10-27T16:02:50","date_gmt":"2025-10-27T09:02:50","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=20681"},"modified":"2025-10-27T16:02:50","modified_gmt":"2025-10-27T09:02:50","slug":"levofloxacin-eye-drops","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/levofloxacin-eye-drops\/","title":{"rendered":"Levofloxacin Eye Drops"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Fluoroquinolone antibacterial.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Levofloxacin Eye Drops are a sterile solution of Levofloxacin Hemihydrate in a suitable vehicle.<\/p>\n<p><em>The eye drops comply with the requirements stated under Eye preparations and with the following requirements.<\/em><\/p>\n<p><strong>Content of levofloxacin, C<sub>18<\/sub>H<sub>20<\/sub>FN<sub>3<\/sub>O<sub>4<\/sub><\/strong><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with solutions (1) and (2) with a diode array detector in the range of 210 to 400 nm.<\/p>\n<p>The UV spectrum of the principal peak in the chromatogram obtained with solution (1) is concordant with that of the peak in the chromatogram obtained with solution (2);<\/p>\n<p>the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<p><strong>Related substances<\/strong><\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<\/p>\n<p>(1) Shake a quantity of the eye drops containing the equivalent of 0.1 g of levofloxacin with 15 mL of 20% v\/v of acetonitrile. Dilute with 20% v\/v of acetonitrile to produce 50 mL and filter (0.45-\u03bcm pore size is suitable). Dilute 1 volume to 4 volumes.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 200 volumes.<\/p>\n<p>(3) Dissolve the contents of a vial of levofloxacin for system suitability EPCRS in 1 mL.<\/p>\n<p>(4) Dilute 1 volume of solution (2) to 5 volumes.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Inertsil ODS is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 0.8 mL per minute.<\/p>\n<p>(d) Use a column temperature of 45\u00b0.<\/p>\n<p>(e) Use a detection wavelength of 360 nm.<\/p>\n<p>(f) Inject 25 \u03bcL of each solution.<\/p>\n<p>(g) Allow the chromatography to proceed for three times the retention time of levofloxacin.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>0.0874% w\/v of copper sulphate pentahydrate, 0.091% w\/v of isoleucine and 0.594% w\/v of ammonium acetate in 30% v\/v of methanol.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurities B and G is at least 1.5.<\/p>\n<h3>CALCULATION OF IMPURITIES<\/h3>\n<p>For all impurities, use the concentration of levofloxacin in solution (2).<\/p>\n<p>For the reporting threshold, use the concentration of levofloxacin in solution (4).<\/p>\n<p>For peak identification, use solution (3).<\/p>\n<p>Levofloxacin retention time: about 20 minutes.<\/p>\n<p>Relative retention: impurity E, about 0.4; impurity B, about 0.5; impurity G, about 0.56; impurity 1, about 0.63; impurity A, about 1.2.<\/p>\n<p>Correction factors: impurity B, multiply by 1.3; impurity E, multiply by 1.7.<\/p>\n<h3>LIMITS<\/h3>\n<p>\u2014 impurity A: not more than 0.8%;<\/p>\n<p>\u2014 unspecified impurities: for each impurity, not more than 0.2%;<\/p>\n<p>\u2014 total unspecified impurities: not more than 1.0%;<\/p>\n<p>\u2014 reporting threshold: 0.1%.<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Shake a quantity of the eye drops containing 0.1 g of levofloxacin with 15 mL of 20% v\/v of acetonitrile. Dilute with 20% v\/v of acetonitrile to produce 100 mL and filter. Dilute 1 volume to 5 volumes with the mobile phase.<\/p>\n<p>(2) 0.2% w\/v of levofloxacin hemihydrate BPCRS in 20% v\/v of acetonitrile, dissolved with the aid of ultrasound if necessary. Dilute 1 volume to 10 volumes with the mobile phase.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Related substances may be used.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C<sub>18<\/sub>H<sub>20<\/sub>FN<sub>3<\/sub>O<sub>4<\/sub> in the eye drops using the declared content of C<sub>18<\/sub>H<sub>20<\/sub>FN<sub>3<\/sub>O4,1\u20442H<sub>2<\/sub>O in levofloxacin hemihydrate BPCRS. Each mg of C<sub>18<\/sub>H<sub>20<\/sub>FN<sub>3<\/sub>O<sub>4<\/sub>,1\u20442H<sub>2<\/sub>O is equivalent to 0.9757 mg of C<sub>18<\/sub>H<sub>20<\/sub>FN<sub>3<\/sub>O<sub>4<\/sub>.<\/p>\n<h2>STORAGE<\/h2>\n<p>Levofloxacin Eye Drops should be kept in an airtight container and protected from light.<\/p>\n<h2>LABELLING<\/h2>\n<p>The quantity of active ingredient is stated in terms of the equivalent amount of levofloxacin.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include impurities A, B, C, D, E, G, H and I listed under Levofloxacin Hemihydrate and:<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-20706\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Eye-Drops-1.jpg\" alt=\"Levofloxacin Eye Drops\" width=\"1200\" height=\"650\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Eye-Drops-1.jpg 1200w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Eye-Drops-1-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Eye-Drops-1-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Levofloxacin-Eye-Drops-1-768x416.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/p>\n<p>1. (S)-4-(6-Carboxy-9-fluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido-[1,2,3-de][1,4]benzoxazine-10-yl)-1-methylpiperazine 1-oxide (N-Oxide)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Fluoroquinolone antibacterial. DEFINITION Levofloxacin Eye Drops are a sterile solution of Levofloxacin Hemihydrate in a suitable vehicle. The eye drops comply with the requirements stated under Eye preparations and with the following requirements. Content of levofloxacin, C18H20FN3O4 95.0 to 105.0% of the stated amount. IDENTIFICATION&#8230;<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20681","post","type-post","status-publish","format-standard","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20681","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=20681"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20681\/revisions"}],"predecessor-version":[{"id":20708,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20681\/revisions\/20708"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20681"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20681"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}