{"id":26154,"date":"2025-11-05T11:31:36","date_gmt":"2025-11-05T04:31:36","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26154"},"modified":"2025-11-06T09:39:55","modified_gmt":"2025-11-06T02:39:55","slug":"nicardipine-hydrochloride","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nicardipine-hydrochloride\/","title":{"rendered":"Nicardipine Hydrochloride"},"content":{"rendered":"

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

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

Calcium channel blocker.<\/p>\n

Ph Eur<\/p>\n

\n

DEFINITION<\/h2>\n

3-[2-[Benzyl(methyl)amino]ethyl] 5-methyl (4RS)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5- dicarboxylate hydrochloride.<\/p>\n

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

99.0 per cent to 101.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

Pale yellow or pale greenish-yellow, crystalline powder.<\/p>\n

Solubility<\/h3>\n

Slightly soluble in water, soluble in methanol, sparingly soluble in ethanol (96 per cent). It shows polymorphism (5.9).<\/p>\n

IDENTIFICATION<\/h2>\n

First identification: A, C. <\/em><\/p>\n

Second identification: B.<\/em><\/p>\n

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

Comparison\u00a0 nicardipine hydrochloride CRS.<\/p>\n

If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in the minimum volume of methanol R, evaporate to dryness and record new spectra using the residues.<\/p>\n

B. Thin-layer chromatography (2.2.27).<\/p>\n

Test solution\u00a0 Dissolve 10 mg of the substance to be examined in methanol R and dilute to 10.0 mL with the same solvent.<\/p>\n

Reference solution\u00a0 Dissolve 10 mg of nicardipine hydrochloride CRS in methanol R and dilute to 10.0 mL with the same solvent.<\/p>\n

Plate\u00a0 TLC silica gel F254 plate R.<\/p>\n

Mobile phase cyclohexane R, ethyl acetate R (40:60 V\/V). Application 2 \u00b5L.<\/p>\n

Development\u00a0 Over 3\/4 of the plate.<\/p>\n

Drying\u00a0 In air.<\/p>\n

Detection A\u00a0 Examine in ultraviolet light at 254 nm.<\/p>\n

Results A\u00a0 The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution.<\/p>\n

Detection B\u00a0 Spray with iodoplatinate reagent R; examine the chromatogram in daylight.<\/p>\n

Results B\u00a0 The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.<\/p>\n

C. Dissolve 30 mg in 10 mL of water R and shake vigorously. The solution gives reaction (a) of chlorides (2.3.1).<\/p>\n

TESTS<\/h2>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29). Carry out the test protected from light.<\/p>\n

Test solution\u00a0 Dissolve 50.0 mg of the substance to be examined in the mobile phase and dilute to 25.0 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. Dilute 1.0 mL of this solution to 20.0 mL with the mobile phase.<\/p>\n

Reference solution (b)\u00a0 Dissolve 4 mg of nicardipine for system suitability CRS (containing impurities A, B and C) in 2 mL of the mobile phase.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n

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

\u2014 temperature: 30 \u00b0C.<\/p>\n

Mobile phase\u00a0 Mix 35 volumes of acetonitrile R and 65 volumes of a 1.5 g\/L solution of perchloric acid R. Flow rate 1.5 mL\/min.<\/p>\n

Detection\u00a0 Spectrophotometer at 254 nm.<\/p>\n

Injection\u00a0 10 \u00b5L.<\/p>\n

Run time\u00a0 4 times the retention time of nicardipine.<\/p>\n

Identification of impurities\u00a0 Use the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A, B and C.<\/p>\n

Relative retention\u00a0 With reference to nicardipine (retention time = about 8 min): impurity B = about 0.5; impurity A = about 0.8; impurity C = about 2.1.<\/p>\n

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

\u2014 resolution: minimum 1.5 between the peaks due to impurity A and nicardipine.<\/p>\n

Calculation of percentage contents:<\/p>\n

\u2014 for each impurity, use the concentration of nicardipine hydrochloride in reference solution (a).<\/p>\n

Limits:<\/p>\n

\u2014 impurity B: maximum 0.5 per cent;<\/p>\n

\u2014 impurities A, C: for each impurity, maximum 0.15 per cent;<\/p>\n

\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n

\u2014 total: maximum 1.0 per cent;<\/p>\n

\u2014 reporting threshold: 0.05 per cent.<\/p>\n

Loss on drying (2.2.32)<\/strong><\/p>\n

Maximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 2 h.<\/p>\n

Sulfated ash (2.4.14)<\/strong><\/p>\n

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

ASSAY<\/h2>\n

Dissolve 0.400 g in 50 mL of ethanol (96 per cent) R. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20).<\/p>\n

1 mL of 0.1 M sodium hydroxide is equivalent to 51.60 mg of C26<\/sub>H30<\/sub>ClN3<\/sub>O6<\/sub>.<\/p>\n

STORAGE<\/h2>\n

In an airtight container, protected from light.<\/p>\n

IMPURITIES<\/h2>\n

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

\"Nicardipine<\/p>\n

A. 3-[2-[benzyl(methyl)amino]ethyl] 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate,<\/p>\n

\"Nicardipine<\/p>\n

B. bis[2-[benzyl(methyl)amino]ethyl]\u00a0 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate,<\/p>\n

\"Nicardipine<\/p>\n

C. dimethyl\u00a0 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate.<\/p>\n

\n

Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Calcium channel blocker. Ph Eur DEFINITION 3-[2-[Benzyl(methyl)amino]ethyl] 5-methyl (4RS)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5- dicarboxylate hydrochloride. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance Pale yellow or pale greenish-yellow, crystalline powder. Solubility Slightly soluble in water, soluble in methanol, sparingly soluble in ethanol (96 per cent)….<\/p>\n","protected":false},"author":5,"featured_media":26128,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26154","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\/26154","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=26154"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26154\/revisions"}],"predecessor-version":[{"id":26752,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26154\/revisions\/26752"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26128"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26154"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26154"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26154"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}