{"id":18737,"date":"2025-10-24T08:56:08","date_gmt":"2025-10-24T01:56:08","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=18737"},"modified":"2025-10-24T08:56:08","modified_gmt":"2025-10-24T01:56:08","slug":"nevirapine-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nevirapine-tablets\/","title":{"rendered":"Nevirapine Tablets"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Non-nucleoside reverse transcriptase inhibitor; antiviral (HIV).<\/p>\n<h2>DEFINITION<\/h2>\n<p>Nevirapine Tablets contain Nevirapine.<\/p>\n<p>The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n<h3>Content of nevirapine, C<sub>15<\/sub>H<sub>14<\/sub>N<sub>4<\/sub>O<\/h3>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>Shake a quantity of the powdered tablets containing 25 mg of Nevirapine with 10 mL of dichloromethane and filter through a sintered-glass funnel. Using a glass syringe, pass the filtrate through a 0.45-\u03bcm PTFE syringe filter and dry the residue at 105\u00b0 for 1 hour. Triturate the dried residue with 0.2 g of potassium bromide. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of nevirapine (RS 507).<\/p>\n<h2>TESTS<\/h2>\n<h3>Dissolution<\/h3>\n<p>Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n<p>TEST CONDITIONS<\/p>\n<p>(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n<p>(b) Use as the medium 900 mL of a phosphate buffer, at a temperature of 37\u00b0, prepared in the following manner. Mix 3.9 mL of orthophosphoric acid and 5.73 g of sodium dihydrogen orthophosphate monohydrate, and dilute to 1000 mL with water. If necessary, adjust the pH to 2.0 using orthophosphoric acid.<\/p>\n<p>PROCEDURE<\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) After 45 minutes withdraw a sample of the medium and filter (a 0.45-\u03bcm Nylon filter is suitable). Use the filtered medium, diluted with the dissolution medium, if necessary, to produce a solution expected to contain 0.0011% w\/v of Nevirapine.<\/p>\n<p>(2) 0.054% w\/v of nevirapine BPCRS in ethanol (96%). Dilute 1 volume to 50 volumes with dissolution medium.<\/p>\n<p>(3) Dissolve the contents of a vial of nevirapine for peak identification EPCRS in 2 mL of the dissolution medium.<\/p>\n<p>Nevirapine Tablets<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (15 cm \u00d7 3.9 mm) packed with end-capped octadecylsilyl silica gel for chromatography (4 \u03bcm) (Nova-pak C18 is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 1.0 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/p>\n<p>(e) Use a detection wavelength of 214 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>23 volumes of acetonitrile R1 and 77 volumes of water R1. When the chromatograms are recorded under the prescribed conditions the retention time of nevirapine is about 4 minutes.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and nevirapine is at least 3.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the total content of nevirapine, C15H14N4O, in the medium from the chromatograms obtained and using the declared content of C15H14N4O in nevirapine BPCRS.<\/p>\n<p>LIMITS<\/p>\n<p>The amount of nevirapine 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.<\/p>\n<p>(1) Mix with the aid of ultrasound a quantity of the powdered tablets containing 0.2 g of Nevirapine with 40 mL of acetonitrile and 20 mL of the mobile phase. Dilute to 200 mL with the mobile phase and filter through a 0.45-\u03bcm membrane filter.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes with the mobile phase. Dilute 1 volume of this solution to 5 volumes with the mobile phase.<\/p>\n<p>(3) Dissolve the contents of a vial of nevirapine for peak identification EPCRS in 2 mL of the mobile phase.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped amidohexadecylsilyl silica gel for chromatography (5 \u03bcm) (Supelcosil LC-ABZ is suitable).<\/p>\n<p>(b) Use isocratic elution and the mobile phase described below.<\/p>\n<p>(c) Use a flow rate of 1.0 mL per minute.<\/p>\n<p>(d) Use a column temperature of 35\u00b0.<\/p>\n<p>(e) Use a detection wavelength of 220 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<p>(g) Allow chromatography to proceed for 4 times the retention time of nevirapine.<\/p>\n<p>MOBILE PHASE<\/p>\n<p>15 volumes of acetonitrile and 85 volumes of a 0.288% w\/v solution of ammonium dihydrogen orthophosphate previously adjusted to pH 5.0 using dilute sodium hydroxide solution.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to nevirapine (retention time about 13 minutes) are: impurity B, about 0.7; impurity A, 1.5; impurity C, about 2.8.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and nevirapine is at least 3.0.<\/p>\n<p>LIMITS<\/p>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any 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 all secondary peaks is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.6%).<\/p>\n<p>Disregard any peak with an area 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 in solution A.<\/p>\n<p>Solution A: equal volumes of ethanol and water.<\/p>\n<p>(1) Mix with the aid of ultrasound a quantity of the powdered tablets containing 0.2 g of Nevirapine with 150 mL, and dilute to 200 mL. Mix and centrifuge a portion of the solution. Dilute 1 volume of the supernatant liquid to 50 volumes, filter through a membrane filter (nominal pore size 0.45 \u03bcm), and use the filtrate.<\/p>\n<p>(2) 0.002% w\/v solution of nevirapine BPCRS.<\/p>\n<p>(3) Dissolve the contents of a vial of nevirapine for peak identification EPCRS in 2 mL.<\/p>\n<p>CHROMATOGRAPHIC CONDITIONS<\/p>\n<p>The chromatographic conditions described under Dissolution may be used.<\/p>\n<p>SYSTEM SUITABILITY<\/p>\n<p>The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and nevirapine is at least 3.0.<\/p>\n<p>DETERMINATION OF CONTENT<\/p>\n<p>Calculate the content of nevirapine, C<sub>15<\/sub>H<sub>14<\/sub>N<sub>4<\/sub>O, in the tablets from the chromatograms obtained and using the declared content of C<sub>15<\/sub>H<sub>14<\/sub>N<sub>4<\/sub>O in nevirapine BPCRS.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include those listed under Nevirapine.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Non-nucleoside reverse transcriptase inhibitor; antiviral (HIV). DEFINITION Nevirapine Tablets contain Nevirapine. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of nevirapine, C15H14N4O 95.0 to 105.0% of the stated amount. IDENTIFICATION Shake a quantity of the powdered tablets containing 25 mg of Nevirapine with 10 mL&#8230;<\/p>\n","protected":false},"author":2,"featured_media":18740,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-18737","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\/18737","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=18737"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18737\/revisions"}],"predecessor-version":[{"id":18742,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/18737\/revisions\/18742"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/18740"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=18737"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=18737"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=18737"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}