{"id":31409,"date":"2025-11-13T15:55:13","date_gmt":"2025-11-13T08:55:13","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=31409"},"modified":"2025-11-13T15:55:13","modified_gmt":"2025-11-13T08:55:13","slug":"vinpocetine","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/vinpocetine\/","title":{"rendered":"Vinpocetine"},"content":{"rendered":"

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

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

Vasodilator.<\/p>\n

DEFINITION<\/h2>\n

Ethyl (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12- carboxylate.<\/p>\n

Content<\/strong><\/p>\n

98.5 per cent to 101.5 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or slightly yellow, crystalline powder.<\/p>\n

Solubility<\/h3>\n

Practically insoluble in water, soluble in methylene chloride, slightly soluble in anhydrous ethanol.<\/p>\n

IDENTIFICATION<\/h2>\n

A. Specific optical rotation (see Tests).<\/p>\n

B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison\u00a0 vinpocetine CRS.<\/p>\n

TESTS<\/h2>\n

Specific optical rotation (2.2.7)<\/p>\n

+ 127 to + 134 (dried substance).<\/p>\n

Dissolve 0.25 g in dimethylformamide R and dilute to 25.0 mL with the same solvent.<\/p>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29).<\/p>\n

Test solution Dissolve 50.0 mg of the substance to be examined in the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n

Reference solution (a)\u00a0 Dilute 1.0 mL of the test solution to 50.0 mL with the mobile phase.<\/p>\n

Reference solution (b) Dissolve 5.0 mg of vinpocetine impurity B CRS, 6.0 mg of vinpocetine impurity A CRS, 5.0 mg of vinpocetine impurity C CRS and 5.0 mg of vinpocetine impurity D CRS in the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n

Reference solution (c) Dilute 1.0 mL of reference solution (a) and 1.0 mL of reference solution (b) to 20.0 mL with the mobile phase.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n

Mobile phase 15.4 g\/L solution of ammonium acetate R, acetonitrile R (45:55 V\/V). Flow rate 1.0 mL\/min.<\/p>\n

Detection\u00a0 Spectrophotometer at 280 nm.<\/p>\n

Injection\u00a0 15 \u00b5L.<\/p>\n

Run time\u00a0 3 times the retention time of vinpocetine.<\/p>\n

Relative retention With reference to vinpocetine (retention time = about 16 min): impurity A = about 0.4; impurity D = about 0.68; impurity B = about 0.75; impurity C = about 0.83.<\/p>\n

System suitability\u00a0 Reference solution (c):<\/p>\n

\u2014 resolution: minimum 2.0 between the peaks due to impurities D and B.<\/p>\n

Limits:<\/p>\n

\u2014 impurity A: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (c) (0.6 per cent);<\/p>\n

\u2014 impurities B, D: for each impurity, not more than the area of the corresponding peak in the chromatogram obtained with reference solution (c) (0.5 per cent);<\/p>\n

\u2014 impurity C: not more than 0.6 times the area of the corresponding peak in the chromatogram obtained with reference solution (c) (0.3 per cent);<\/p>\n

\u2014 unspecified impurities: for each impurity, not more than the area of the peak due to vinpocetine in the chromatogram obtained with reference solution (c) (0.10 per cent);<\/p>\n

\u2014 total: not more than 10 times the area of the peak due to vinpocetine in the chromatogram obtained with reference solution (c) (1.0 per cent);<\/p>\n

\u2014 disregard limit: 0.5 times the area of the peak due to vinpocetine in the chromatogram obtained with reference solution (c) (0.05 per cent).<\/p>\n

Loss on drying (2.2.32)<\/h4>\n

Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo in an oven at 100 \u00b0C for 3 h.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n

Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\n

Dissolve 0.300 g in 50 mL of a mixture of equal volumes of acetic anhydride R and anhydrous acetic acid R. Titrate with<\/p>\n

0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20). 1 mL of 0.1 M perchloric acid is equivalent to 35.05 mg of C22<\/sub>H26<\/sub>N2<\/sub>O2<\/sub>.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities\u00a0 A, B, C, D.<\/em><\/p>\n

A. ethyl (12S,13aS,13bS)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate),<\/p>\n

B. methyl (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12- carboxylate (apovincamine),<\/p>\n

C. ethyl (13aS,13bS)-13a-ethyl-10-methoxy-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (methoxyvinpocetine),<\/p>\n

D. ethyl (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine).<\/p>\n","protected":false},"excerpt":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Vasodilator. DEFINITION Ethyl (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12- carboxylate. Content 98.5 per cent to 101.5 per cent (dried substance). CHARACTERS Appearance White or slightly yellow, crystalline powder. Solubility Practically insoluble in water, soluble in methylene chloride, slightly soluble in anhydrous ethanol. IDENTIFICATION A. Specific optical rotation (see Tests). B….<\/p>\n","protected":false},"author":5,"featured_media":31410,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-31409","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31409","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=31409"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31409\/revisions"}],"predecessor-version":[{"id":31440,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/31409\/revisions\/31440"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/31410"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=31409"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=31409"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=31409"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}