{"id":19367,"date":"2025-10-24T17:29:28","date_gmt":"2025-10-24T10:29:28","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19367"},"modified":"2025-10-24T17:29:28","modified_gmt":"2025-10-24T10:29:28","slug":"ofloxacin-eye-drops","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/ofloxacin-eye-drops\/","title":{"rendered":"Ofloxacin Eye Drops"},"content":{"rendered":"

Action and use<\/strong><\/p>\n

Fluoroquinolone antibacterial.<\/p>\n

DEFINITION<\/h2>\n
Ofloxacin Eye Drops are a sterile solution of Ofloxacin in a suitable vehicle.<\/p>\n
The eye drops comply with the requirements stated under Eye Preparations and with the following requirements.<\/p>\n
Content of ofloxacin, C_{18<\/sub>H_{20<\/sub>FN_{3<\/sub>O_{4<\/sub><\/h3>\n93.0 to 107.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\nIn 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
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
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
TESTS<\/h2>\n
Related substances<\/h3>\nCarry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in solution A.<\/p>\n
Solution A: 10 volumes of acetonitrile and 90 volumes of 0.01M hydrochloric acid.<\/p>\n
Solution B: 0.308% w\/v of ammonium acetate and 0.538% w\/v of sodium perchlorate in water, adjusted to pH 2.2 using orthophosphoric acid.<\/p>\n
(1) Dilute a suitable volume of the eye drops to produce a solution containing 0.04% w\/v of Ofloxacin.<\/p>\n
(2) Dilute 1 volume of solution (1) to 200 volumes.<\/p>\n
(3) 0.00008% w\/v each of ofloxacin impurity D EPCRS and ofloxacin impurity E EPCRS and 0.0002% w\/v of ofloxacin BPCRS.<\/p>\n
(4) Dilute 1 volume of solution (2) to 5 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (3 \u03bcm) (YMC Pack Pro C18 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.0 mL per minute.<\/p>\n
(d) Use a column temperature of 38\u00b0.<\/p>\n
(e) Use a detection wavelength of 294 nm.<\/p>\n
(f) Inject 10 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
Mobile phase A: 16 volumes of acetonitrile and 84 volumes of solution B.<\/p>\n
Mobile phase B: 20 volumes of methanol, 30 volumes of acetonitrile and 50 volumes of solution B.<\/p>\n\n\n\n\n\n\n\n\n\nTime (Minutes) <\/strong><\/td>\n Mobile phase A (% v\/v) <\/strong><\/td>\n Mobile phase B (% v\/v) <\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-5<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n
5-10<\/td>\n 100\u219282<\/td>\n 0\u219218<\/td>\n linear gradient<\/td>\n<\/tr>\n
10-15<\/td>\n 82\u219240<\/td>\n 18\u219260<\/td>\n linear gradient<\/td>\n<\/tr>\n
15-30<\/td>\n 40<\/td>\n 60<\/td>\n isocractic<\/td>\n<\/tr>\n
30-32<\/td>\n 40\u2192100<\/td>\n 60\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n
32-40<\/td>\n 100<\/td>\n 0<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nSYSTEM SUITABILITY<\/p>\n
The test is not valid unless:<\/p>\n
in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity E and ofloxacin is at least 2.0 and;<\/p>\n
in the chromatogram obtained with solution (4), the signal-to-noise ratio of the peak due to ofloxacin is at least 90.<\/p>\n
CALCULATION OF IMPURITIES<\/p>\n
For each impurity, use the concentration of ofloxacin in solution (2).<\/p>\n
For the reporting threshold, use the concentration of ofloxacin in solution (4).<\/p>\n
For peak identification, use solution (3).<\/p>\n
Ofloxacin retention time: about 10 minutes.<\/p>\n
Relative retention: impurity D, about 0.7; impurity E, about 0.9.<\/p>\n
Correction factors: impurity D, multiply by 4.5.<\/p>\n
LIMITS<\/p>\n
\u2014 impurity D: not more than 0.2%;<\/p>\n
\u2014 up to one impurity: not more than 0.8%<\/p>\n
\u2014 any other impurities: not more than 0.2%;<\/p>\n
\u2014 total impurities: not more than 1.0%;<\/p>\n
\u2014 reporting threshold: 0.1%.<\/p>\n
ASSAY<\/h2>\nCarry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Dilute a suitable volume of the eye drops with 10% v\/v of acetonitrile to produce a solution containing 0.001% w\/v of Ofloxacin.<\/p>\n
(2) Prepare a 0.1% w\/v solution of ofloxacin BPCRS in methanol and dilute 1 volume of this solution to 100 volumes with 10% v\/v of acetonitrile.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (10 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (3.5 \u03bcm) (Symmetry C18 is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 2.0 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 294 nm.<\/p>\n
(f) Inject 20 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
10 volumes of acetonitrile and 90 volumes of a solution containing 2.72% w\/v of potassium dihydrogen orthophosphate, previously adjusted to pH 3.3 with orthophosphoric acid.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (2), the symmetry factor of the principal peak is not greater than 2.0.<\/p>\n
DETERMINATION OF CONTENT<\/p>\n
Calculate the content of ofloxacin, C_{18<\/sub>H_{20<\/sub>FN_{3<\/sub>O_{4<\/sub>, in the eye drops from the chromatograms obtained and using the declared content of C_{18<\/sub>H_{20<\/sub>FN_{3<\/sub>O_{4<\/sub> in ofloxacin BPCRS.<\/p>\n}}}}}}}}
IMPURITIES<\/h2>\nThe impurities limited by the requirements of this monograph include impurities B, C, D, E and F listed under Ofloxacin.<\/p>\n","protected":false},"excerpt":{"rendered":"
Action and use Fluoroquinolone antibacterial. DEFINITION Ofloxacin Eye Drops are a sterile solution of Ofloxacin in a suitable vehicle. The eye drops comply with the requirements stated under Eye Preparations and with the following requirements. Content of ofloxacin, C18H20FN3O4 93.0 to 107.0% of the stated amount. IDENTIFICATION In the Assay, record the UV spectrum of…<\/p>\n","protected":false},"author":2,"featured_media":19398,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19367","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19367","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=19367"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19367\/revisions"}],"predecessor-version":[{"id":19400,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19367\/revisions\/19400"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19398"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19367"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19367"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19367"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}}}}}

Time (Minutes) <\/strong><\/td>\n	Mobile phase A (% v\/v) <\/strong><\/td>\n	Mobile phase B (% v\/v) <\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-5<\/td>\n	100<\/td>\n	0<\/td>\n	isocratic<\/td>\n<\/tr>\n
5-10<\/td>\n	100\u219282<\/td>\n	0\u219218<\/td>\n	linear gradient<\/td>\n<\/tr>\n
10-15<\/td>\n	82\u219240<\/td>\n	18\u219260<\/td>\n	linear gradient<\/td>\n<\/tr>\n
15-30<\/td>\n	40<\/td>\n	60<\/td>\n	isocractic<\/td>\n<\/tr>\n
30-32<\/td>\n	40\u2192100<\/td>\n	60\u21920<\/td>\n	linear gradient<\/td>\n<\/tr>\n
32-40<\/td>\n	100<\/td>\n	0<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless:<\/p>\n in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity E and ofloxacin is at least 2.0 and;<\/p>\n in the chromatogram obtained with solution (4), the signal-to-noise ratio of the peak due to ofloxacin is at least 90.<\/p>\n CALCULATION OF IMPURITIES<\/p>\n For each impurity, use the concentration of ofloxacin in solution (2).<\/p>\n For the reporting threshold, use the concentration of ofloxacin in solution (4).<\/p>\n For peak identification, use solution (3).<\/p>\n Ofloxacin retention time: about 10 minutes.<\/p>\n Relative retention: impurity D, about 0.7; impurity E, about 0.9.<\/p>\n Correction factors: impurity D, multiply by 4.5.<\/p>\n LIMITS<\/p>\n \u2014 impurity D: not more than 0.2%;<\/p>\n \u2014 up to one impurity: not more than 0.8%<\/p>\n \u2014 any other impurities: not more than 0.2%;<\/p>\n \u2014 total impurities: not more than 1.0%;<\/p>\n \u2014 reporting threshold: 0.1%.<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dilute a suitable volume of the eye drops with 10% v\/v of acetonitrile to produce a solution containing 0.001% w\/v of Ofloxacin.<\/p>\n (2) Prepare a 0.1% w\/v solution of ofloxacin BPCRS in methanol and dilute 1 volume of this solution to 100 volumes with 10% v\/v of acetonitrile.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (10 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (3.5 \u03bcm) (Symmetry C18 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2.0 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 294 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/p>\n 10 volumes of acetonitrile and 90 volumes of a solution containing 2.72% w\/v of potassium dihydrogen orthophosphate, previously adjusted to pH 3.3 with orthophosphoric acid.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (2), the symmetry factor of the principal peak is not greater than 2.0.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the content of ofloxacin, C_{18<\/sub>H_{20<\/sub>FN_{3<\/sub>O_{4<\/sub>, in the eye drops from the chromatograms obtained and using the declared content of C_{18<\/sub>H_{20<\/sub>FN_{3<\/sub>O_{4<\/sub> in ofloxacin BPCRS.<\/p>\n}}}}}}}} IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include impurities B, C, D, E and F listed under Ofloxacin.<\/p>\n","protected":false},"excerpt":{"rendered":" Action and use Fluoroquinolone antibacterial. DEFINITION Ofloxacin Eye Drops are a sterile solution of Ofloxacin in a suitable vehicle. The eye drops comply with the requirements stated under Eye Preparations and with the following requirements. Content of ofloxacin, C18H20FN3O4 93.0 to 107.0% of the stated amount. IDENTIFICATION In the Assay, record the UV spectrum of…<\/p>\n","protected":false},"author":2,"featured_media":19398,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19367","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19367","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=19367"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19367\/revisions"}],"predecessor-version":[{"id":19400,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19367\/revisions\/19400"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19398"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19367"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19367"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19367"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}