{"id":14856,"date":"2025-10-16T09:18:29","date_gmt":"2025-10-16T02:18:29","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=14856"},"modified":"2025-10-16T09:19:42","modified_gmt":"2025-10-16T02:19:42","slug":"fluconazole-capsules","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/fluconazole-capsules\/","title":{"rendered":"Fluconazole Capsules"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Antifungal.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Fluconazole Capsules contain Fluconazole.<\/p>\n<p>The capsules comply with the requirements stated under Capsules and with the following requirements.<\/p>\n<p><strong>Content of fluconazole, C<sub>13<\/sub>H<sub>12<\/sub>F<sub>2<\/sub>N<sub>6<\/sub>O<\/strong><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<br \/>\n(1) Shake a quantity of the powdered capsule contents containing 100 mg of Fluconazole with 10 mL of methanol. Filter<br \/>\nand use the filtrate.<br \/>\n(2) 1.0% w\/v of fluconazole BPCRS in methanol.<br \/>\n(3) 0.2% w\/v of fluconazole BPCRS and 0.1% w\/v of ketoconazole BPCRS in methanol.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use as the coating silica gel F254.<br \/>\n(b) Use the mobile phase as described below.<br \/>\n(c) Apply 10 \u03bcL of each solution.<br \/>\n(d) Develop the plate to 15 cm.<br \/>\n(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>1 volume of 13.5M ammonia, 20 volumes of methanol and 80 volumes of dichloromethane.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.<\/p>\n<h3>CONFIRMATION<\/h3>\n<p>The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<\/p>\n<p>B. In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) corresponds to that of the principal peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<p><strong>Dissolution<\/strong><\/p>\n<p>Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n<h3>TEST CONDITIONS<\/h3>\n<p>(a) Use Apparatus 1, and rotate the basket at 100 revolutions per minute.<br \/>\n(b) Use 900 mL of 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n<h3>PROCEDURE<\/h3>\n<p>(1) After 45 minutes withdraw a sample of the medium and measure the absorbance of the filtered sample, diluted with the dissolution medium, if necessary, to produce a solution containing 0.0056% w\/v of Fluconazole, at 261 nm, Appendix II B using dissolution medium in the reference cell.<br \/>\n(2) Measure the absorbance of a 0.0056% w\/v solution of fluconazole BPCRS in dissolution medium at 261 nm using dissolution medium in the reference cell.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the total content of fluconazole, C<sub>13<\/sub>H<sub>12<\/sub>F<sub>2<\/sub>N<sub>6<\/sub>O, in the medium from the absorbances obtained and using the declared content of C<sub>13<\/sub>H<sub>12<\/sub>F<sub>2<\/sub>N<sub>6<\/sub>O in fluconazole BPCRS.<\/p>\n<h3>LIMITS<\/h3>\n<p>The amount of fluconazole released is not less than 75% (Q) of the stated amount.<\/p>\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.<br \/>\n(1) To a quantity of powdered capsule contents containing 0.5 g of Fluconazole, add 25 mL and mix with the aid of ultrasound. Dilute to produce 50 mL, filter and use the filtrate.<br \/>\n(2) Dilute 1 volume of solution (1) to 100 volumes and further dilute 1 volume to 10 volumes.<br \/>\n(3) 0.1% w\/v of fluconazole impurity standard BPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Waters Symmetry C18 is suitable).<br \/>\n(b) Use isocratic elution and the mobile phase described below.<br \/>\n(c) Use a flow rate of 1.0 mL per minute.<br \/>\n(d) Use a column temperature of 40\u00b0.<br \/>\n(e) Use a detection wavelength of 260 nm.<br \/>\n(f) Inject 20 \u03bcL of each solution.<br \/>\n(g) Allow the chromatography to proceed for 3.5 times the retention time of fluconazole.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>14 volumes of acetonitrile and 86 volumes of 0.01M ammonium formate.<br \/>\nWhen the chromatograms are recorded under the prescribed conditions, the retention times relative to fluconazole (retention time about 11 minutes) are: impurity B, about 0.4; impurity A, about 0.5 and impurity C, about 0.8.<\/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<br \/>\nimpurity C and fluconazole is at least 3.0.<\/p>\n<h3>LIMITS<\/h3>\n<p>Identify any peaks corresponding to impurities B and C in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and multiply the areas of these peaks by correction factors of 0.15 and 0.05, respectively.<br \/>\nIn the chromatogram obtained with solution (1):<br \/>\nthe area of any peak due to impurity A is not greater than 4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.4%);<br \/>\nthe area of any peak due to impurity B is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<br \/>\nthe area of any other secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<br \/>\nthe total content of impurities is not greater than 10 times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).<br \/>\nDisregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Weigh and powder the content of 20 capsules. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<br \/>\n(1) To a quantity of powdered capsule contents containing 0.5 g of Fluconazole add 50 mL, mix with the aid of ultrasound and dilute to produce 100 mL. Dilute 1 volume to 10 volumes, filter and use the filtrate.<br \/>\n(2) 0.05% w\/v of fluconazole BPCRS.<br \/>\n(3) 0.1% w\/v of fluconazole impurity standard BPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Related substances may be used.<\/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 impurity C and fluconazole is at least 3.0.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C<sub>13<\/sub>H<sub>12<\/sub>F<sub>2<\/sub>N<sub>6<\/sub>O in the capsules using the declared content of C<sub>13<\/sub>H<sub>12<\/sub>F<sub>2<\/sub>N<sub>6<\/sub>O in fluconazole BPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those listed under Fluconazole.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Antifungal. DEFINITION Fluconazole Capsules contain Fluconazole. The capsules comply with the requirements stated under Capsules and with the following requirements. Content of fluconazole, C13H12F2N6O 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. (1) Shake a quantity of&#8230;<\/p>\n","protected":false},"author":5,"featured_media":14866,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-14856","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\/14856","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=14856"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14856\/revisions"}],"predecessor-version":[{"id":14882,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14856\/revisions\/14882"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14866"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14856"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14856"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}