{"id":19140,"date":"2025-10-24T15:21:45","date_gmt":"2025-10-24T08:21:45","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19140"},"modified":"2025-10-24T15:21:45","modified_gmt":"2025-10-24T08:21:45","slug":"nabumetone-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nabumetone-tablets\/","title":{"rendered":"Nabumetone Tablets"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

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

Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.<\/p>\n

DEFINITION<\/h2>\n
Nabumetone Tablets contain Nabumetone.<\/p>\n
The tablets comply with the requirements stated under Tablets and with the following requirements.<\/em><\/p>\n
Content of nabumetone, C_{15<\/sub>H_{16<\/sub>O_{2<\/sub><\/strong><\/p>\n}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
The infrared absorption spectrum of the powdered tablets, Appendix II A, is concordant with the reference spectrum of nabumetone\u00a0 (RS 239).<\/p>\n
TESTS<\/h2>\n
Related substances<\/strong><\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in acetonitrile.<\/p>\n
(1) Shake a quantity of the powdered tablets containing 0.25 g of Nabumetone with 50 mL of acetonitrile, filter through a glass-fibre filter (Whatman GF\/C is suitable) and use the filtrate.<\/p>\n
(2) Dilute 1 volume of solution (1) to 200 volumes.<\/p>\n
(3) 0.0015% w\/v of nabumetone impurity F EPCRS.<\/p>\n
(4) 0.002% w\/v of each of nabumetone BPCRS and nabumetone impurity D BPCRS.<\/p>\n
(5) Dilute 1 volume of solution (2) to 10 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated octadecylsilyl silica gel for chromatography (4 \u00b5m) (Genesis C18 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use a column temperature of 40\u00b0.<\/p>\n
(e) Use a detection wavelength of 254 nm.<\/p>\n
(f) Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
Mobile phase A<\/em> 12 volumes of tetrahydrofuran, 28 volumes of acetonitrile and 60 volumes of a 0.1% v\/v solution of glacial acetic acid in carbon dioxide-free water.<\/p>\n
Mobile phase B<\/em> 24 volumes of tetrahydrofuran, 56 volumes of acetonitrile and 20 volumes of a 0.1% v\/v solution of glacial acetic acid in carbon dioxide-free water.<\/p>\n\n\n\n\n\n\n\n\n
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
0-12<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n
12-28<\/td>\n 100\u21920<\/td>\n 0\u2192100<\/td>\n linear gradient<\/td>\n<\/tr>\n
28-33<\/td>\n 0<\/td>\n 100<\/td>\n isocratic<\/td>\n<\/tr>\n
33-34<\/td>\n 0\u2192100<\/td>\n 100\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n
34-35<\/td>\n 100<\/td>\n 0<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to nabumetone (retention time about 11 minutes) are: impurity D, about 1.1 and impurity F, about 2.7.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the two principal peaks is at least 1.5.<\/p>\n
LIMITS<\/h3>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to impurity F is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.3%);<\/p>\n
the area of any other secondary peak is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n
the sum of the areas of any other secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).<\/p>\n
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (5) (0.05%).<\/p>\n
ASSAY<\/h2>\n
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) To a quantity of powdered tablets containing 0.5 g of Nabumetone, add 400 mL of acetonitrile, mix with the aid of ultrasound, allow to cool, add sufficient acetonitrile to produce 500 mL, mix and filter through a glass-fibre filter (Whatman GF\/C is suitable). Dilute 1 volume of the filtrate to 20 volumes with the mobile phase.<\/p>\n
(2) Dilute 1 volume of a 0.1% w\/v solution of nabumetone BPCRS in acetonitrile to 20 volumes with the mobile phase.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated octadecylsilyl silica gel for chromatography (4 \u00b5m) (Genesis C18 is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 254 nm.<\/p>\n
(f) Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
18 volumes of tetrahydrofuran, 40 volumes of a 0.1% v\/v solution of glacial acetic acid in carbon dioxide-free water and 42 volumes of acetonitrile.<\/p>\n
When the chromatograms are recorded under the prescribed conditions the retention time of nabumetone is about 4 minutes.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of nabumetone, C_{15<\/sub>H_{16<\/sub>O_{2<\/sub>, in the tablets from the chromatograms obtained and using the declared content of C_{15<\/sub>H_{16<\/sub>O_{2<\/sub> in nabumetone BPCRS.<\/p>\n}}}}}}
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Nabumetone.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. DEFINITION Nabumetone Tablets contain Nabumetone. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of nabumetone, C15H16O2 95.0 to 105.0% of the stated amount. IDENTIFICATION The infrared absorption spectrum of the powdered tablets, Appendix II…<\/p>\n","protected":false},"author":5,"featured_media":19141,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19140","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\/19140","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=19140"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19140\/revisions"}],"predecessor-version":[{"id":19149,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19140\/revisions\/19149"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19141"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19140"}],"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
0-12<\/td>\n	100<\/td>\n	0<\/td>\n	isocratic<\/td>\n<\/tr>\n
12-28<\/td>\n	100\u21920<\/td>\n	0\u2192100<\/td>\n	linear gradient<\/td>\n<\/tr>\n
28-33<\/td>\n	0<\/td>\n	100<\/td>\n	isocratic<\/td>\n<\/tr>\n
33-34<\/td>\n	0\u2192100<\/td>\n	100\u21920<\/td>\n	linear gradient<\/td>\n<\/tr>\n
34-35<\/td>\n	100<\/td>\n	0<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to nabumetone (retention time about 11 minutes) are: impurity D, about 1.1 and impurity F, about 2.7.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the two principal peaks is at least 1.5.<\/p>\n LIMITS<\/h3>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity F is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.3%);<\/p>\n the area of any other secondary peak is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n the sum of the areas of any other secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).<\/p>\n Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (5) (0.05%).<\/p>\n ASSAY<\/h2>\n Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) To a quantity of powdered tablets containing 0.5 g of Nabumetone, add 400 mL of acetonitrile, mix with the aid of ultrasound, allow to cool, add sufficient acetonitrile to produce 500 mL, mix and filter through a glass-fibre filter (Whatman GF\/C is suitable). Dilute 1 volume of the filtrate to 20 volumes with the mobile phase.<\/p>\n (2) Dilute 1 volume of a 0.1% w\/v solution of nabumetone BPCRS in acetonitrile to 20 volumes with the mobile phase.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h3>\n (a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated octadecylsilyl silica gel for chromatography (4 \u00b5m) (Genesis C18 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 254 nm.<\/p>\n (f) Inject 20 \u00b5L of each solution.<\/p>\n MOBILE PHASE<\/h3>\n 18 volumes of tetrahydrofuran, 40 volumes of a 0.1% v\/v solution of glacial acetic acid in carbon dioxide-free water and 42 volumes of acetonitrile.<\/p>\n When the chromatograms are recorded under the prescribed conditions the retention time of nabumetone is about 4 minutes.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Calculate the content of nabumetone, C_{15<\/sub>H_{16<\/sub>O_{2<\/sub>, in the tablets from the chromatograms obtained and using the declared content of C_{15<\/sub>H_{16<\/sub>O_{2<\/sub> in nabumetone BPCRS.<\/p>\n}}}}}} IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Nabumetone.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. DEFINITION Nabumetone Tablets contain Nabumetone. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of nabumetone, C15H16O2 95.0 to 105.0% of the stated amount. IDENTIFICATION The infrared absorption spectrum of the powdered tablets, Appendix II…<\/p>\n","protected":false},"author":5,"featured_media":19141,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19140","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\/19140","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=19140"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19140\/revisions"}],"predecessor-version":[{"id":19149,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19140\/revisions\/19149"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19141"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the two principal peaks is at least 1.5.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nCalculate the content of nabumetone, C15<\/sub>H16<\/sub>O2<\/sub>, in the tablets from the chromatograms obtained and using the declared content of C15<\/sub>H16<\/sub>O2<\/sub> in nabumetone BPCRS.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the two principal peaks is at least 1.5.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of nabumetone, C_{15<\/sub>H_{16<\/sub>O_{2<\/sub>, in the tablets from the chromatograms obtained and using the declared content of C_{15<\/sub>H_{16<\/sub>O_{2<\/sub> in nabumetone BPCRS.<\/p>\n}}}}}}