{"id":17481,"date":"2025-10-22T11:45:47","date_gmt":"2025-10-22T04:45:47","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=17481"},"modified":"2025-10-22T11:45:47","modified_gmt":"2025-10-22T04:45:47","slug":"hydrocortisone-cream","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/hydrocortisone-cream\/","title":{"rendered":"Hydrocortisone Cream"},"content":{"rendered":"<p data-start=\"302\" data-end=\"352\">General Notices<br data-start=\"317\" data-end=\"320\" \/><strong>Action and use<\/strong><br data-start=\"334\" data-end=\"337\" \/>Corticosteroid.<\/p>\n<h2 data-start=\"354\" data-end=\"364\">DEFINITION<\/h2>\n<p data-start=\"366\" data-end=\"632\">Hydrocortisone Cream contains Hydrocortisone in a suitable basis.<br data-start=\"431\" data-end=\"434\" \/>The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.<br data-start=\"556\" data-end=\"559\" \/>Content of hydrocortisone, C21H30O5: 90.0 to 110.0% of the stated amount.<\/p>\n<h2 data-start=\"634\" data-end=\"648\">IDENTIFICATION<\/h2>\n<p data-start=\"650\" data-end=\"751\">A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n<p data-start=\"753\" data-end=\"1185\">For creams containing more than 0.5% w\/w of Hydrocortisone:<\/p>\n<p data-start=\"753\" data-end=\"1185\">(1) Mix a quantity containing 25 mg of Hydrocortisone with 10 mL of methanol (90%), add 50 mL of hot hexane and shake. Separate the lower layer, add 5 g of anhydrous sodium sulfate, mix and filter through a glass microfibre filter (Whatman GF\/C is suitable).<\/p>\n<p data-start=\"753\" data-end=\"1185\">(2) 0.25% w\/v of hydrocortisone BPCRS in methanol.<\/p>\n<p data-start=\"753\" data-end=\"1185\">(3) A mixture of equal volumes of solutions (1) and (2).<\/p>\n<p data-start=\"1187\" data-end=\"1465\">For creams containing 0.5% w\/w or less of Hydrocortisone:<\/p>\n<p data-start=\"1187\" data-end=\"1465\">(1) Prepare in the same manner as solution (1) above but use a quantity containing 5 mg of Hydrocortisone.<\/p>\n<p data-start=\"1187\" data-end=\"1465\">(2) 0.05% w\/v of hydrocortisone BPCRS in methanol.<\/p>\n<p data-start=\"1187\" data-end=\"1465\">(3) A mixture of equal volumes of solutions (1) and (2).<\/p>\n<h3 data-start=\"1467\" data-end=\"1493\">CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p data-start=\"1495\" data-end=\"1767\">(a) Use as the coating silica gel G.<br data-start=\"1531\" data-end=\"1534\" \/>(b) Use the mobile phase as described below.<br data-start=\"1578\" data-end=\"1581\" \/>(c) Apply 5 \u03bcL of each solution.<br data-start=\"1613\" data-end=\"1616\" \/>(d) Develop the plate to 15 cm.<br data-start=\"1647\" data-end=\"1650\" \/>(e) After removal of the plate, dry in air, spray with alkaline tetrazolium blue solution and examine in white light.<\/p>\n<h3 data-start=\"1769\" data-end=\"1781\">MOBILE PHASE<\/h3>\n<p data-start=\"1783\" data-end=\"1882\">1.2 volumes of water, 8 volumes of methanol, 15 volumes of ether and 77 volumes of dichloromethane.<\/p>\n<h3 data-start=\"1884\" data-end=\"1896\">CONFIRMATION<\/h3>\n<p data-start=\"1898\" data-end=\"2148\">The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2); if it does not, the principal spot in the chromatogram obtained with solution (3) appears as a single, compact spot.<\/p>\n<p data-start=\"2150\" data-end=\"2334\">B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to hydrocortisone in the chromatogram obtained with solution (3).<\/p>\n<h2 data-start=\"2336\" data-end=\"2341\">ASSAY<\/h2>\n<p data-start=\"2343\" data-end=\"2437\">Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p data-start=\"2439\" data-end=\"3353\">For creams containing more than 0.5% w\/w of Hydrocortisone:<\/p>\n<p data-start=\"2439\" data-end=\"3353\">Prepare a 0.5% w\/v solution of betamethasone (internal standard) in methanol (solution A).<\/p>\n<p data-start=\"2439\" data-end=\"3353\">(1) Disperse, by shaking, a quantity of the cream containing 25 mg of Hydrocortisone in 40 mL of a mixture of 3 volumes of methanol and 1 volume of a 15% w\/v solution of sodium chloride. Add 50 mL of hot hexane, shake and separate the lower layer. Repeat the extraction using a further two 10-mL quantities of the methanolic sodium chloride solution. To the combined extracts add 5 mL of solution A and sufficient water to produce 100 mL, mix and filter through a glass microfibre paper (Whatman GF\/C is suitable).<\/p>\n<p data-start=\"2439\" data-end=\"3353\">(2) Prepare in the same manner as solution (1), but add 5 mL of methanol in place of the 5 mL of solution A.<\/p>\n<p data-start=\"2439\" data-end=\"3353\">(3) Dissolve 25 mg of hydrocortisone BPCRS in 45 mL of methanol, add 5 mL of solution A and add sufficient water to produce 100 mL.<\/p>\n<p data-start=\"3355\" data-end=\"4266\">For creams containing 0.5% w\/w or less of Hydrocortisone:<\/p>\n<p data-start=\"3355\" data-end=\"4266\">Prepare a 0.110% w\/v solution of betamethasone (internal standard) in methanol (solution B).<\/p>\n<p data-start=\"3355\" data-end=\"4266\">(1) Disperse, by shaking, a quantity of the cream containing 5 mg of Hydrocortisone in 40 mL of a mixture of 3 volumes of methanol and 1 volume of a 15% w\/v solution of sodium chloride. Add 50 mL of hot hexane, shake and separate the lower layer. Repeat the extraction using a further two 10-mL quantities of the methanolic sodium chloride solution. To the combined extracts add 5 mL of solution B and sufficient water to produce 100 mL, mix and filter through a glass microfibre paper (Whatman GF\/C is suitable).<\/p>\n<p data-start=\"3355\" data-end=\"4266\">(2) Prepare in the same manner as solution (1), but add 5 mL of methanol in place of the 5 mL of solution B.<\/p>\n<p data-start=\"3355\" data-end=\"4266\">(3) Dissolve 5 mg of hydrocortisone BPCRS in 45 mL of methanol and add 5 mL of solution B and sufficient water to produce 100 mL.<\/p>\n<h3 data-start=\"4268\" data-end=\"4294\">CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p data-start=\"4296\" data-end=\"4669\">(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).<br data-start=\"4439\" data-end=\"4442\" \/>(b) Use isocratic elution and the mobile phase described below.<br data-start=\"4505\" data-end=\"4508\" \/>(c) Use a flow rate of 2 mL per minute.<br data-start=\"4547\" data-end=\"4550\" \/>(d) Use an ambient column temperature.<br data-start=\"4588\" data-end=\"4591\" \/>(e) Use a detection wavelength of 240 nm.<br data-start=\"4632\" data-end=\"4635\" \/>(f) Inject 20 \u03bcL of each solution.<\/p>\n<h3 data-start=\"4671\" data-end=\"4683\">MOBILE PHASE<\/h3>\n<p data-start=\"4685\" data-end=\"4700\">methanol (50%).<\/p>\n<h3 data-start=\"4702\" data-end=\"4726\">DETERMINATION OF CONTENT<\/h3>\n<p data-start=\"4728\" data-end=\"4866\">Calculate the content of C21H30O5 in the cream using the ratios of the peaks and the declared content of C21H30O5 in hydrocortisone BPCRS.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>General NoticesAction and useCorticosteroid. DEFINITION Hydrocortisone Cream contains Hydrocortisone in a suitable basis.The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.Content of hydrocortisone, C21H30O5: 90.0 to 110.0% of the stated amount. IDENTIFICATION A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. For&#8230;<\/p>\n","protected":false},"author":5,"featured_media":17483,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-17481","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\/17481","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=17481"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17481\/revisions"}],"predecessor-version":[{"id":17487,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17481\/revisions\/17487"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17483"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17481"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17481"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17481"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}