Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Corticosteroid.<\/p>\n Hydrocortisone Acetate Ointment contains Hydrocortisone Acetate in a suitable basis.<\/p>\n The ointment complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.<\/p>\n Content of hydrocortisone acetate, C23<\/sub>H32<\/sub>O6<\/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 For ointments containing more than 0.5% w\/w of Hydrocortisone Acetate<\/strong><\/p>\n (1) Disperse a quantity containing 25 mg of Hydrocortisone Acetate in 5 mL of hot hexane, cool, extract with 10 mL of methanol (90%) and filter.<\/p>\n (2) Equal volumes of solution (1) and a 0.25% w\/v solution of hydrocortisone acetate BPCRS in methanol.<\/p>\n For ointments containing 0.5% w\/w or less of Hydrocortisone Acetate<\/strong><\/p>\n (1) Disperse a quantity containing 5 mg of Hydrocortisone Acetate in 5 mL of hot hexane, cool, extract with 10 mL of methanol (90%) and filter.<\/p>\n (2) Equal volumes of solution (1) and a 0.05% w\/v solution of hydrocortisone acetate BPCRS in methanol.<\/p>\n (a) Use as the coating silica gel G.<\/p>\n (b) Use the mobile phase as described below.<\/p>\n (c) Apply 5 \u03bcL of each solution.<\/p>\n (d) After removal of the plate, dry in air and spray with alkaline tetrazolium blue solution.<\/p>\n 1.2 volumes of water, 8 volumes of methanol, 15 volumes of ether and 77 volumes of dichloromethane.<\/p>\n The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2) which appears as a single, compact spot.<\/p>\n B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to hydrocortisone acetate in the chromatogram obtained with solution (1).<\/p>\n Carry out the method for liquid chromatography, Appendix III D using the following solutions.<\/p>\n For ointments containing more than 0.5% w\/w of Hydrocortisone Acetate<\/strong><\/p>\n (1) Disperse a quantity of the ointment containing 25 mg of Hydrocortisone Acetate in 100 mL of hot hexane, cool and extract with 20 mL of a solution prepared by mixing 3 volumes of methanol and 1 volume of a 15% w\/v solution of sodium chloride. Repeat the extraction using two 10-mL quantities of the methanolic sodium chloride solution. Add 5 mL of methanol to the combined extracts and sufficient water to produce 100 mL, mix and filter through a glass microfibre filter (Whatman GF\/C is suitable).<\/p>\n (2) Dissolve 25 mg of hydrocortisone acetate BPCRS in 45 mL of methanol, add 5 mL of a 0.5% w\/v solution of betamethasone (internal standard) in methanol and sufficient water to produce 100 mL.<\/p>\n (3) Prepare in the same manner as solution (1) but add 5 mL of the internal standard solution in place of the 5 mL of methanol before diluting to volume.<\/p>\n For ointments containing 0.5% w\/w or less of Hydrocortisone Acetate<\/strong><\/p>\n (1) Disperse a quantity of the ointment containing 5 mg of Hydrocortisone Acetate in 100 mL of hot hexane, cool and extract with 20 mL of a solution prepared by mixing 3 volumes of methanol and 1 volume of a 15% w\/v solution of sodium chloride. Repeat the extraction using two 10-mL quantities of the methanolic sodium chloride solution. Add 5 mL of methanol to the combined extracts and sufficient water to produce 100 mL, mix and filter through a glass microfibre filter (Whatman GF\/C is suitable).<\/p>\n (2) Dissolve 5 mg of hydrocortisone acetate BPCRS in 45 mL of methanol, add 5 mL of a 0.110% w\/v solution of betamethasone (internal standard) in methanol and add sufficient water to produce 100 mL.<\/p>\n (3) Prepare in the same manner as solution (1) but add 5 mL of the internal standard solution in place of the 5 mL of methanol before diluting to volume.<\/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 an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 240 nm.<\/p>\n (f) Inject 20 \u03bcL of each solution.<\/p>\n 50 volumes of methanol and 50 volumes of water.<\/p>\n Calculate the content of C23<\/sub>H32<\/sub>O6 <\/sub>in the ointment using the declared content of C23<\/sub>H32<\/sub>O6 <\/sub>in hydrocortisone acetate BPCRS.<\/p>\n Hydrocortisone Acetate Ointment should be protected from light.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Corticosteroid. DEFINITION Hydrocortisone Acetate Ointment contains Hydrocortisone Acetate in a suitable basis. The ointment complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements. Content of hydrocortisone acetate, C23H32O6 90.0 to 110.0% of the stated amount. IDENTIFICATION A. Carry out the…<\/p>\n","protected":false},"author":5,"featured_media":17265,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-17264","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\/17264","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=17264"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17264\/revisions"}],"predecessor-version":[{"id":17268,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17264\/revisions\/17268"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17265"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17264"}],"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
CONFIRMATION<\/h3>\n
ASSAY<\/h2>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
MOBILE PHASE<\/h3>\n
DETERMINATION OF CONTENT<\/h3>\n
STORAGE<\/h2>\n