Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Glucocorticoid.<\/p>\n Betamethasone and Clioquinol Cream contains Betamethasone Valerate and Clioquinol, the latter in very fine powder, in a suitable basis.<\/p>\n The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.<\/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 Content of clioquinol, C9<\/sub>H5<\/sub>ClINO<\/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) Disperse a quantity of the preparation being examined containing the equivalent of 0.5 mg of betamethasone in 20 mL of methanol (80%) by heating on a water bath until the methanol begins to boil. Shake vigorously, cool in ice and centrifuge. Transfer 10 mL of the supernatant liquid to a separating funnel, add 3 mL of water and 5 mL of chloroform, shake vigorously, allow the layers to separate and evaporate the chloroform layer to dryness in a current of nitrogen with gentle heating. Dissolve the residue in 1 mL of chloroform.<\/p>\n (2) 0.03% w\/v of betamethasone valerate BPCRS in chloroform.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/strong><\/p>\n (a) Use as the coating silica gel G.<\/p>\n (b) Use the mobile phase as described below.<\/p>\n (c) Apply 10 \u03bcL of each solution.<\/p>\n (d) Develop the plate to 15 cm.<\/p>\n (e) After removal of the plate, allow it to dry in air, heat at 105\u00b0 for 5 minutes and spray while hot with alkaline tetrazolium blue solution.<\/p>\n MOBILE PHASE<\/strong><\/p>\n 5 volumes of absolute ethanol, 10 volumes of acetone and 100 volumes of chloroform.<\/p>\n CONFIRMATION<\/strong><\/p>\n The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).<\/p>\n B. In the Assay for betamethasone the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to betamethasone valerate in the chromatogram obtained with solution (3).<\/p>\n C. In the Assay for clioquinol the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to clioquinol in the chromatogram obtained with solution (2).<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Shake a quantity of the cream containing the equivalent of 2 mg of betamethasone with 100 mL of hot hexane for 2 minutes, cool, extract the mixture with 20 mL of ethanol (96%) and filter the lower, ethanolic layer through absorbent cotton previously washed with ethanol (75%). Repeat the extraction of the hexane mixture with two 10-mL quantities of ethanol (75%), filtering each extract in turn through the absorbent cotton and dilute the combined filtrates to 50 mL with ethanol (75%).<\/p>\n (2) Prepared in the same manner as solution (1) but add 5 mL of a 0.072% w\/v solution of beclometasone dipropionate BPCRS (internal standard) in ethanol (80%) before diluting to 50 mL.<\/p>\n (3) Mix 2 volumes of a solution containing 0.024% w\/v of betamethasone valerate BPCRS and 0.0012% w\/v of betamethasone 21-valerate BPCRS in ethanol (80%) with 1 volume of a 0.072% w\/v solution of the internal standard in ethanol (80%) and dilute to 10 volumes with the same solvent.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/strong><\/p>\n (a) Use a stainless steel column (10 cm \u00d7 5 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (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 238 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/strong><\/p>\n 42 volumes of absolute ethanol and 58 volumes of water.<\/p>\n SYSTEM SUITABILITY<\/strong><\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to betamethasone valerate (retention time about 5 minutes) and betamethasone 21-valerate (retention time about 7 minutes) is more than 1.0, if necessary adjust the mixture of absolute ethanol and water in the mobile phase.<\/p>\n DETERMINATION OF CONTENT<\/strong><\/p>\n Calculate the content of C22<\/sub>H29<\/sub>FO5<\/sub> in the cream using the declared content of C22<\/sub>H29<\/sub>FO5<\/sub> in betamethasone valerate BPCRS.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Add 80 mL of a hot 80% v\/v solution of 2-methoxyethanol to a quantity of the cream containing 30 mg of Clioquinol and heat on a water bath for 5 minutes, swirling vigorously. Cool to room temperature, dilute to 100 mL with the same solvent, mix and filter. To 5 mL of the filtrate add 1 mL of a solution containing 1% w\/v of nickel(II) chloride hexahydrate and dilute to 50 mL with the mobile phase.<\/p>\n (2) Mix 5 mL of a solution containing 0.024% w\/v of clioquinol BPCRS in an 80% v\/v solution of 2-methoxyethanol and 1 mL of a solution containing 1% w\/v of nickel(II) chloride hexahydrate in water and dilute to 50 mL with the mobile phase.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/strong><\/p>\n (a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with phenyl silica gel for chromatography (5 \u03bcm) (Spherisorb Phenyl is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.5 mL per minute.<\/p>\n (d) Use an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 273 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/strong><\/p>\n 0.024% w\/v of nickel(II) chloride hexahydrate in a mixture of 2 volumes of methanol, 3 volumes of acetonitrile and 5 volumes of water.<\/p>\n DETERMINATION OF CONTENT<\/strong><\/p>\n Calculate the content of C9<\/sub>H5<\/sub>ClINO in the cream using the declared content of C9H5ClINO in clioquinol BPCRS.<\/p>\n Betamethasone and Clioquinol Cream should be protected from light.<\/p>\n The quantity of active ingredient with respect to Betamethasone Valerate 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 and Clioquinol Cream contains Betamethasone Valerate and Clioquinol, the latter in very fine powder, in a suitable basis. The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements. Content of betamethasone, C22H29FO5 90.0 to 110.0% of…<\/p>\n","protected":false},"author":5,"featured_media":4130,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-4126","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\/4126","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=4126"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4126\/revisions"}],"predecessor-version":[{"id":5848,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4126\/revisions\/5848"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/4130"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=4126"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=4126"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=4126"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
IDENTIFICATION<\/h2>\n
ASSAY<\/h2>\n
For betamethasone<\/h3>\n
For clioquinol<\/h3>\n
STORAGE<\/h2>\n
LABELLING<\/h2>\n