Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use <\/strong><\/p>\n Glucocorticoid.<\/p>\n Betamethasone Sodium Phosphate Tablets contain Betamethasone Sodium Phosphate.<\/p>\n The tablets comply with the requirements stated under Tablets and with the following requirements.<\/em><\/p>\n Content of betamethasone, C22<\/sub>H29<\/sub>FO5<\/sub><\/strong><\/p>\n 90.0 to 110.0% of the stated amount.<\/p>\n A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n (1) Dissolve a quantity of the powdered tablets containing the equivalent of 2 mg of betamethasone in 25 mL of water, add 2.5 g of sodium chloride and 1 mL of hydrochloric acid, extract with 25 mL of chloroform and discard the chloroform layer. Extract with 25 mL of tributyl orthophosphate and discard the aqueous layer.<\/p>\n (2) Prepare in the same manner as solution (1) but using 2.5 mg of betamethasone sodium phosphate BPCRS in place of the powdered tablets.<\/p>\n (3) Mix equal volumes of solutions (1) and (2).<\/p>\n (4) Mix equal volumes of solution (1) and a solution prepared in the same manner as solution (1) but using 2.5 mg of prednisolone sodium phosphate BPCRS in place of the powdered tablets.<\/p>\n (a) Use as the coating silica gel G.<\/p>\n (b) Use the mobile phase as described below prepared immediately before use.<\/p>\n (c) Apply 5 \u00b5L of each solution.<\/p>\n (d) Develop the plate to 15 cm.<\/p>\n (e) After removal of the plate, dry in air, heat at 110\u00b0 for 10 minutes, spray the hot plate with ethanolic sulfuric acid (20%) and again heat at 110\u00b0 for 10 minutes.<\/p>\n 20 volumes of acetic anhydride, 20 volumes of water and 60 volumes of butan-1-ol prepared immediately before use.<\/p>\n The test is not valid unless the chromatogram obtained with solution (4) shows two principal spots with almost identical Rf values.<\/p>\n The chromatograms obtained with solutions (1), (2) and (3) show single spots with identical Rf values.<\/p>\n B. Mix a quantity of the powdered tablets containing the equivalent of 0.4 mg of betamethasone with 1 mL of sulfuric acid and allow to stand for 5 minutes. A pale yellow colour is produced (distinction from prednisolone sodium phosphate tablets).<\/p>\n Disintegration<\/strong><\/p>\n Maximum time, 5 minutes, Appendix XII A1.<\/p>\n Uniformity of content<\/strong><\/p>\n Tablets containing less than the equivalent of 2 mg and\/or less than 2% w\/w of betamethasone comply with the requirements stated under Tablets using the following method of analysis. Carry out the procedure protected from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dissolve one tablet as completely as possible in 5 mL of water, add 5 mL of methanol and filter.Add sufficient (2) 0.0065% w\/v of betamethasone sodium phosphate BPCRS in water. Dilute 1 volume of this solution to 2 volumes with methanol.<\/p>\n (a) Use a stainless steel column (20 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (10 \u00b5m) (Spherisorb ODS 1 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 2 mL per minute.<\/p>\n (d) Use a column temperature of 60\u00b0.<\/p>\n (e) Use a detection wavelength of 241 nm.<\/p>\n (f) Inject 20 \u00b5L of each solution.<\/p>\n 45 volumes of methanol and 55 volumes of citro-phosphate buffer pH 5.0.<\/p>\n Calculate the content of C22<\/sub>H29<\/sub>FO5<\/sub> in each tablet, determining the exact strength of the solution of betamethasone sodium phosphate BPCRS as described in the Assay.<\/p>\n Weigh and powder 20 tablets. Carry out the procedure protected from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Shake a quantity of the powdered tablets containing 2.5 mg of betamethasone for 20 minutes with 25 mL of water, dilute to 50 mL with methanol, mix and filter through a glass fibre filter (Whatman GF\/C is suitable).<\/p>\n (2) Dilute 5 mL of a 0.014% w\/v solution of betamethasone sodium phosphate BPCRS in water (solution A) to 10 mL with The chromatographic procedure described under Uniformity of content may be used.<\/p>\n Calculate the content of C22<\/sub>H29<\/sub>FO5<\/sub> in the tablets, determining the exact strength of C22<\/sub>H29<\/sub>FO5<\/sub> in solution (2) as follows. Dilute 5 mL of solution A to 25 mL with water and measure the absorbance, Appendix II B, of the resulting solution at the maximum at 241 nm, taking 391 as the value of A(1%, 1 cm) for betamethasone.<\/p>\n Betamethasone Sodium Phosphate Tablets should be protected from light.<\/p>\n The quantity of active ingredient is stated in terms of the equivalent amount of betamethasone.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Glucocorticoid. DEFINITION Betamethasone Sodium Phosphate Tablets contain Betamethasone Sodium Phosphate. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of betamethasone, C22H29FO5 90.0 to 110.0% of the stated amount. IDENTIFICATION A. Carry out the method for thin-layer chromatography, Appendix…<\/p>\n","protected":false},"author":5,"featured_media":6108,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-6105","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\/6105","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=6105"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6105\/revisions"}],"predecessor-version":[{"id":6124,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/6105\/revisions\/6124"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/6108"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=6105"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=6105"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=6105"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
SYSTEM SUITABILITY<\/h3>\n
CONFIRMATION<\/h3>\n
TESTS<\/h2>\n
\nmethanol (50%) to produce a solution expected to contain 0.00325% w\/v of betamethasone sodium phosphate.<\/p>\nCHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
ASSAY<\/h2>\n
\nmethanol.<\/p>\nCHROMATOGRAPHIC CONDITIONS<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
STORAGE<\/h2>\n
LABELLING<\/h2>\n