{"id":16411,"date":"2025-10-21T09:58:41","date_gmt":"2025-10-21T02:58:41","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16411"},"modified":"2025-10-21T09:58:41","modified_gmt":"2025-10-21T02:58:41","slug":"lacidipine","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/lacidipine\/","title":{"rendered":"Lacidipine"},"content":{"rendered":"<p>C<sub>26<\/sub>H<sub>33<\/sub>NO<sub>6<\/sub> \u00a0 \u00a0 \u00a0455.6\u00a0 \u00a0 \u00a0 \u00a0103890-78-4<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Calcium channel blocker.<\/p>\n<p><strong>Preparation<\/strong><\/p>\n<p>Lacidipine Tablets<\/p>\n<h2>DEFINITION<\/h2>\n<p>Lacidipine is diethyl (E)-4-{2-[(tert-butoxycarbonyl)vinyl]phenyl}-1,4-dihydro-2,6-dimethylpyridine-3,5- dicarboxylate. It contains not less than 97.5% and not more than 102.0% of C26H33NO6, calculated with reference to the anhydrous, propan-2-ol\u2013free substance.<\/p>\n<h2>CHARACTERISTICS<\/h2>\n<p>A white to pale yellow crystalline powder. It melts at about 178\u00b0.<\/p>\n<p>Practically insoluble in water; freely soluble in acetone; sparingly soluble in absolute ethanol.<\/p>\n<p>Carry out all of the following procedures protected from light and prepare solutions immediately before use.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of Lacidipine (RS 407).<\/p>\n<p>B. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n<h3>TESTS<\/h3>\n<h4>Propan-2-ol<\/h4>\n<p>Carry out the method for gas chromatography, Appendix III B. Prepare a 0.002% v\/v solution of 1,4-dioxan (internal standard) in dimethylacetamide (solution A).<\/p>\n<p>(1) 0.002% v\/v solution of propan-2-ol in solution A.<\/p>\n<p>(2) 2% w\/v of the substance being examined in solution A.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a glass column (60 m \u00d7 0.32 mm) bonded with a film (5 \u03bcm) of polymethylsiloxane (CP-Sil 5CB is suitable).<\/p>\n<p>(b) Use helium as the carrier gas at 1.7 mL per minute.<\/p>\n<p>(c) Use a temperature gradient as described below.<\/p>\n<p>(d) Use an injection temperature of 170\u00b0.<\/p>\n<p>(e) Use a detector temperature of 250\u00b0.<\/p>\n<p>(f) Inject 1 \u03bcL of each solution.<\/p>\n<p>&nbsp;<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless the chromatogram obtained with solution (1) shows two clearly separated peaks.<\/p>\n<p>The retention time for propan-2-ol is about 6.2 minutes and that for dioxan is about 15 minutes.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (2): the percentage content of propan-2-ol is not more than 0.5% w\/w.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Dilute 1 volume of a 0.1% w\/v solution of the substance being examined in absolute ethanol to 5 volumes with the mobile phase.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 500 volumes with the mobile phase.<\/p>\n<p>(3) Dilute 1 volume of a 0.1% w\/v solution of lacidipine impurity standard BPCRS in absolute ethanol to 5 volumes with the mobile phase.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (25 cm x 4.6 mm) packed with cyanosilyl silica gel for chromatography (5 \u03bcm) (Spherisorb CN is suitable).<\/p>\n<p>(b) Use isocratic elution using the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 2 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 240 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>(g) If necessary adjust the composition of the mobile phase so that, in the chromatogram obtained with solution (3), the retention time of the peak due to lacidipine is about 10 minutes.<\/p>\n<p>(h) For solution (1), allow the chromatography to proceed for 2 times the retention time of the principal peak.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>3 volumes of absolute ethanol and 97 volumes of n-hexane.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless the chromatogram obtained with solution (3) closely resembles the chromatogram supplied with lacidipine impurity standard BPCRS.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any peak due to lacidipine impurity B is not greater than 0.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%, taking into account the correction factor of 0.5);<\/p>\n<p>the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n<p>the total nominal content of impurities is not greater than 0.5%.<\/p>\n<h4>Water<\/h4>\n<p>Not more than 0.2% w\/w, Appendix IX C. Use 0.5 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Dilute 5 volumes of a 0.1% w\/v solution of the substance being examined in absolute ethanol to 100 volumes with the mobile phase.<\/p>\n<p>(2) Dilute 5 volumes of a 0.1% w\/v solution of lacidipine BPCRS in absolute ethanol to 100 volumes with the mobile phase.<\/p>\n<p>(3) Dilute 1 volume of a 0.1% w\/v solution of lacidipine impurity standard BPCRS in absolute ethanol to 5 volumes with the mobile phase.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The chromatographic procedure described under Related substances may be used.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless the chromatogram obtained with solution (3) closely resembles the corresponding chromatogram supplied with lacidipine impurity standard BPCRS.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of C<sub>26<\/sub>H<sub>33<\/sub>NO<sub>6<\/sub> from the chromatograms obtained and using the declared content of C<sub>26<\/sub>H<sub>33<\/sub>NO<sub>6<\/sub> in lacidipine BPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16698\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-A-300x163.jpg\" alt=\"Lacidipine\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-A-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-A-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-A-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-A.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>A. Ethyl methyl (E)-4-{2-[2-(tert-butoxycarbonyl)vinyl]phenyl}-1,4-dihydro-2,6-dimethylpyridine-3,5- dicarboxylate,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16699\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-B-300x163.jpg\" alt=\"Lacidipine\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-B-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-B-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-B-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-B.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>B. Diethyl (E)-4-{2-[2-(tert-butoxycarbonyl)vinyl]phenyl}-2,6-dimethylpyridine-3,5-dicarboxylate,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-16700\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-C-300x163.jpg\" alt=\"Lacidipine\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-C-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-C-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-C-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/Lacidipine-C.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. Diethyl (Z)-4-{2-[2-(tert-butoxycarbonyl)vinyl]phenyl}-1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>C26H33NO6 \u00a0 \u00a0 \u00a0455.6\u00a0 \u00a0 \u00a0 \u00a0103890-78-4 Action and use Calcium channel blocker. Preparation Lacidipine Tablets DEFINITION Lacidipine is diethyl (E)-4-{2-[(tert-butoxycarbonyl)vinyl]phenyl}-1,4-dihydro-2,6-dimethylpyridine-3,5- dicarboxylate. It contains not less than 97.5% and not more than 102.0% of C26H33NO6, calculated with reference to the anhydrous, propan-2-ol\u2013free substance. CHARACTERISTICS A white to pale yellow crystalline powder. It melts at about&#8230;<\/p>\n","protected":false},"author":2,"featured_media":16701,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-16411","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\/16411","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=16411"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16411\/revisions"}],"predecessor-version":[{"id":16702,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16411\/revisions\/16702"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16701"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16411"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16411"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16411"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}