{"id":15646,"date":"2025-10-17T17:32:55","date_gmt":"2025-10-17T10:32:55","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=15646"},"modified":"2025-10-17T17:32:55","modified_gmt":"2025-10-17T10:32:55","slug":"fenofibrate-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/fenofibrate-tablets\/","title":{"rendered":"Fenofibrate Tablets"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Fibrate; lipid-regulating drug.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Fenofibrate Tablets contain Fenofibrate.<\/p>\n<p>The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n<p>Content of fenofibrate, C<sub>20<\/sub>H<sub>21<\/sub>ClO<sub>4<\/sub><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>Disperse a quantity of the powdered tablets containing 0.2 g of Fenofibrate in 20 mL of acetone, filter through a 0.45-\u03bcm nylon syringe filter and evaporate to dryness under a stream of nitrogen. Add 5 mL of water to the residue and mix with the aid of ultrasound. Filter the suspension and dry the resulting powder at 60\u00b0 at a pressure of 1 kPa for 30 minutes. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of fenofibrate (RS 511).<\/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 2, rotating the paddle at 50 revolutions per minute.<br \/>\n(b) Use 900 mL of 0.05M sodium lauryl sulfate, at a temperature of 37\u00b0, as the medium.<\/p>\n<h3>PROCEDURE<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) After 45 minutes withdraw a sample of the medium and filter. Use the filtered medium, diluted with 0.025M sodium dodecyl sulfate, if necessary, to produce a solution expected to contain 0.0074% w\/v of Fenofibrate.<br \/>\n(2) 0.0074% w\/v of fenofibrate BPCRS in 0.025M sodium dodecyl sulfate.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a stainless steel column (25 cm \u00d7 4.0 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Hypersil 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 an ambient column temperature.<br \/>\n(e) Use a detection wavelength of 286 nm.<br \/>\n(f) Inject 5 \u03bcL of each solution.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>30 volumes of water previously adjusted to pH 2.5 with orthophosphoric acid and 70 volumes of acetonitrile.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the retention time of fenofibrate is about 10 minutes.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the total content of fenofibrate, C<sub>20<\/sub>H<sub>21<\/sub>ClO<sub>4<\/sub>, in the medium from the chromatograms obtained and using the declared content of C<sub>20<\/sub>H<sub>21<\/sub>ClO<sub>4<\/sub> in fenofibrate BPCRS.<\/p>\n<h3>LIMITS<\/h3>\n<p>The amount of fenofibrate 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 prepared in the mobile phase.<\/p>\n<p>(1) Shake a quantity of the powdered tablets containing 0.1 g of Fenofibrate with 80 mL of the mobile phase, mix with the aid of ultrasound and intermittent shaking. Dilute to 100 mL, mix and filter (a 0.45-\u03bcm nylon syringe filter is suitable).<br \/>\n(2) Dilute 1 volume of solution (1) to 100 volumes. Further dilute 1 volume to 5 volumes.<br \/>\n(3) 0.0001% w\/v each of fenofibrate impurity A EPCRS and fenofibrate impurity B EPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Dissolution may be used with an injection volume of 20 \u03bcL. Allow the chromatography to proceed for twice the retention time of fenofibrate.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to fenofibrate (retention time about 10 minutes) are: impurity A, about 0.34 and impurity B, about 0.36.<\/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 A and impurity B is at least 1.5.<\/p>\n<h3>LIMITS<\/h3>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n<p>the sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).<\/p>\n<p>Disregard any peak with an area less than half 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 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in the mobile phase.<\/p>\n<p>(1) Shake a quantity of the powdered tablets containing 0.1 g of Fenofibrate with 80 mL of the mobile phase, mix with the aid of ultrasound and intermittent shaking. Dilute to 100 mL, mix and filter (a 0.45-\u03bcm nylon syringe filter is suitable).<br \/>\n(2) 0.1% w\/v of fenofibrate BPCRS.<br \/>\n(3) 0.0001% w\/v each of fenofibrate impurity A EPCRS and fenofibrate impurity B EPCRS.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under Dissolution may be used with an injection volume of 10 \u03bcL.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity A and impurity B is at least 1.5.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C<sub>20<\/sub>H<sub>21<\/sub>ClO<sub>4<\/sub> in the tablets from the chromatograms obtained and using the declared content of C<sub>20<\/sub>H<sub>21<\/sub>ClO<sub>4<\/sub> in fenofibrate BPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those listed under Fenofibrate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Fibrate; lipid-regulating drug. DEFINITION Fenofibrate Tablets contain Fenofibrate. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of fenofibrate, C20H21ClO4 95.0 to 105.0% of the stated amount. IDENTIFICATION Disperse a quantity of the powdered tablets containing 0.2 g of&#8230;<\/p>\n","protected":false},"author":5,"featured_media":15669,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-15646","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\/15646","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=15646"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/15646\/revisions"}],"predecessor-version":[{"id":15743,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/15646\/revisions\/15743"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/15669"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=15646"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=15646"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=15646"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}