﻿{"id":22256,"date":"2025-10-29T17:28:31","date_gmt":"2025-10-29T10:28:31","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22256"},"modified":"2025-10-29T17:28:31","modified_gmt":"2025-10-29T10:28:31","slug":"zuclopenthixol-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/zuclopenthixol-tablets\/","title":{"rendered":"Zuclopenthixol Tablets"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Dopamine receptor antagonist; neuroleptic.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Zuclopenthixol Tablets contain Zuclopenthixol Hydrochloride.<\/p>\n<p>The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n<p><strong>Content of zuclopenthixol, C<sub>22<\/sub>H<sub>25<\/sub>ClN<sub>2<\/sub>OS<\/strong><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. To a quantity of the powdered tablets containing the equivalent of 20 mg of zuclopenthixol add 40 mL of 0.1M hydrochloric acid, heat on a water bath for 30 minutes, shaking occasionally, cool, dilute to 200 mL with water and shake thoroughly. Centrifuge a portion of the resulting solution and dilute 20 mL of the supernatant liquid to 200 mL with water. Measure the absorbance, Appendix II B at 230 nm using 0.002M hydrochloric acid in the reference cell. The light absorption, Appendix II B, in the range 205 to 350 nm of a 0.0015% w\/v solution in ethanol (96%) exhibits maxima at 230, 268 and 325 nm.<\/p>\n<p>B. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<h3>Dissolution<\/h3>\n<p>Comply with the dissolution test for tablets and capsules, Appendix XII B1. Carry out the procedure protected from light.<\/p>\n<h4>TEST CONDITIONS<\/h4>\n<p>(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n<p>(b) Use 900 mL of 0.01M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n<h4>PROCEDURE<\/h4>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions<\/p>\n<p>(1) After 30 minutes withdraw a sample of the medium, filter and dilute with the dissolution medium, if necessary, to produce a solution expected to contain the equivalent of 0.0002% w\/v of zuclopenthixol.<\/p>\n<p>(2) 0.00024% w\/v of zuclopenthixol hydrochloride BPCRS in the dissolution medium.<\/p>\n<p>(3) 0.002% w\/v each of zuclopenthixol hydrochloride BPCRS and trans-clopenthixol hydrochloride BPCRS (impurity B) in solution A.<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>(a) Use a stainless steel column (15 cm \u00d7 2.1 mm) packed with octylsilyl silica gel for chromatography (3.5 \u03bcm) (Symmetry Shield RP18 is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 0.6 mL per minute.<\/p>\n<p>(d) Use a column temperature maintained at 40\u00b0.<\/p>\n<p>(e) Use a detection wavelength of 270 nm.<\/p>\n<p>(f) Inject 250 \u03bcL of each solution.<\/p>\n<p>(g) allow the chromatography to proceed for 1.5 times the retention time of zuclopenthixol (retention time about 6 miuntes).<\/p>\n<h4>MOBILE PHASE<\/h4>\n<p>2 volumes of trifluoroacetic acid, 9 volumes of acetonitrile and 41 volumes of water.<\/p>\n<h4>SYSTEM SUITABILITY<\/h4>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks corresponding to zuclopenthixol and trans-clopenthixol hydrochloride is at least 2.0.<\/p>\n<h4>DETERMINATION OF CONTENT<\/h4>\n<p>Calculate the total content of zuclopenthixol, C<sub>22<\/sub>H<sub>25<\/sub>ClN<sub>2<\/sub>OS, in the medium from the chromatograms obtained and the declared content of C<sub>22<\/sub>H<sub>25<\/sub>ClN<sub>2<\/sub>OS, in zuclopenthixol hydrochloride BPCRS.<\/p>\n<h4>LIMITS<\/h4>\n<p>The amount of zuclopenthixol released is not less than 75% (Q) of the stated amount.<\/p>\n<h3>Related substances<\/h3>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions protected from light.<\/p>\n<p>Solution A 18 volumes of acetonitrile and 82 volumes of water.<\/p>\n<p>(1) Shake a quantity of the powdered tablets containing the equivalent of 25 mg of zuclopenthixol with 5 mL of Solution A with the aid of ultrasound. Add 15 mL of Solution A, place in a water bath for 20 minutes, allow to cool and dilute to 25 mL with solution A.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes with solution A, further dilute 1 volume of this solution to 5 volumes with solution A.<\/p>\n<p>(3) Dilute 3 volumes of solution (1) to 100 volumes with solution A.<\/p>\n<p>(4) 0.002% w\/v each of zuclopenthixol hydrochloride BPCRS and trans-clopenthixol hydrochloride BPCRS (impurity B) in solution A.<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>(a) Use a stainless steel column (5 cm \u00d7 2.1 mm) packed with octadecylsilyl silica gel for chromatography (3.5 \u03bcm) (Symmetry Shield RP18 is suitable).<\/p>\n<p>(b) Use gradient elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 0.6 ml per minute.<\/p>\n<p>(d) Use a column temperature 40\u00b0.<\/p>\n<p>(e) Use a detection wavelength of 270 nm.<\/p>\n<p>(f) Inject 5 \u03bcL of each solution.<\/p>\n<h4>MOBILE PHASE<\/h4>\n<p>Mobile phase A: 1 volume of trifluoroacetic acid and 25 volumes of water.<\/p>\n<p>Mobile phase B: 1 volume of trifluoroacetic acid and 25 volumes of acetonitrile.<\/p>\n<p>Mobile phase C: methanol.<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 148px;\">\n<tbody>\n<tr style=\"height: 64px;\">\n<td style=\"width: 20%; height: 64px; text-align: center;\"><strong>Time (Minutes)<\/strong><\/td>\n<td style=\"width: 20%; height: 64px; text-align: center;\"><strong>Mobile phase A (% v\/v)<\/strong><\/td>\n<td style=\"width: 20%; height: 64px; text-align: center;\"><strong>Mobile phase A (% v\/v)<\/strong><\/td>\n<td style=\"width: 20%; height: 64px; text-align: center;\"><strong>Mobile phase A (% v\/v)<\/strong><\/td>\n<td style=\"width: 20%; height: 64px; text-align: center;\"><strong>Comment<\/strong><\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 20%; height: 21px; text-align: center;\">0-8<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">82<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">18<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">0<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">isocratic<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 20%; height: 21px; text-align: center;\">8-17<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">82\u21925<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">18\u219210<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">0\u219285<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">linear gradient<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 20%; height: 21px; text-align: center;\">17-19<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">5\u219282<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">10\u219218<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">85\u21920<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">linear gradient<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 20%; height: 21px; text-align: center;\">19-30<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">82<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">18<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">0<\/td>\n<td style=\"width: 20%; height: 21px; text-align: center;\">re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>When the chromatograms are recorded under the prescribed conditions, the retention times relative to zuclopenthixol (retention time about 6 minutes) are: impurity A, about 0.1; trans-clopenthixol hydrochloride, about 1.2.<\/p>\n<h4>SYSTEM SUITABILITY<\/h4>\n<p>The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks corresponding to zuclopenthixol and trans-clopenthixol hydrochloride is at least 2.0.<\/p>\n<h4>LIMITS<\/h4>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>The area of any peak due to trans-zuclopenthixol is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (3%).<\/p>\n<p>The area of any peak due to zuclopenthixol impurity A is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%).<\/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 sum of the areas of any secondary peak, excluding trans-clopenthixol hydrochloride, is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1%).<\/p>\n<p>Disregard any peak with an area of less than half the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions protected from light.<\/p>\n<p>Solution A: 18 volumes of acetonitrile and 82 volumes of water.<\/p>\n<p>(1) To a quantity of the powdered tablets containing the equivalent of 25 mg of zuclopenthixol add 50 mL of solution A and mix with the aid of ultrasound. Add 150 mL of solution A and place in a water bath for 20 minutes, allow to cool and dilute to 250 mL with solution A.<\/p>\n<p>(2) 0.012% w\/v of zuclopenthixol hydrochloride BPCRS in solution A.<\/p>\n<p>(3) 0.002% w\/v each of zuclopenthixol hydrochloride BPCRS and trans-clopenthixol hydrochloride BPCRS (impurity B) in solution A.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>The chromatographic conditions described under the Dissolution may be used, with an injection volume of 5\u03bcL.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks corresponding to zuclopenthixol and trans-clopenthixol hydrochloride is at least 2.0.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the total content of zuclopenthixol, C<sub>22<\/sub>H<sub>25<\/sub>ClN<sub>2<\/sub>OS, in the medium from the chromatograms obtained and the declared content of C<sub>22<\/sub>H<sub>25<\/sub>ClN<sub>2<\/sub>OS, in zuclopenthixol hydrochloride BPCRS.<\/p>\n<h2>LABELLING<\/h2>\n<p>The quantity of active ingredient is stated in terms of the equivalent amount of zuclopenthixol.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those shown under Zuclopenthixol Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Dopamine receptor antagonist; neuroleptic. DEFINITION Zuclopenthixol Tablets contain Zuclopenthixol Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of zuclopenthixol, C22H25ClN2OS 95.0 to 105.0% of the stated amount. IDENTIFICATION A. To a quantity of the powdered tablets containing the equivalent of 20 mg of zuclopenthixol&#8230;<\/p>\n","protected":false},"author":4,"featured_media":22267,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22256","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\/22256","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=22256"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22256\/revisions"}],"predecessor-version":[{"id":22269,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22256\/revisions\/22269"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22267"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22256"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22256"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22256"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}