{"id":20659,"date":"2025-10-27T16:00:24","date_gmt":"2025-10-27T09:00:24","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=20659"},"modified":"2025-10-27T16:00:24","modified_gmt":"2025-10-27T09:00:24","slug":"salbutamol-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/salbutamol-tablets\/","title":{"rendered":"Salbutamol Tablets"},"content":{"rendered":"<p><strong>Action and use<\/strong><\/p>\n<p>Beta<sub>2<\/sub>-adrenoceptor agonist; bronchodilator.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Salbutamol Tablets contain Salbutamol Sulfate.<\/p>\n<p>The tablets comply with the requirements stated under Tablets and with the following requirements.<\/p>\n<p><strong>Content of salbutamol, C<sub>13<\/sub>H<sub>21<\/sub>NO<sub>3<\/sub><\/strong><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with solutions (1) and (2) with a diode array detector in the range of 210 to 400 nm.<\/p>\n<p>The UV spectrum of the principal peak in the chromatogram obtained with solution (1) is concordant with that of the peak in the chromatogram obtained with solution (2); the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n<p>B. Shake a quantity of the powdered tablets containing the equivalent of 4 mg of salbutamol with 10 mL of water and filter. The filtrate yields the reactions characteristic of sulfates, Appendix VI.<\/p>\n<h2>TESTS<\/h2>\n<h3>Dissolution<\/h3>\n<p>Carry out the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n<h4>TEST CONDITIONS<\/h4>\n<p>(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.<\/p>\n<p>(b) Use 500 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 45 minutes withdraw a sample of the medium and filter (a 0.45-\u03bcm cellulose acetate filter is suitable). Dilute with the dissolution medium, if necessary, to produce a solution expected to contain the equivalent of 0.0004% w\/v of salbutamol.<\/p>\n<p>(2) 0.00048% w\/v of salbutamol sulfate BPCRS in water.<\/p>\n<p>(3) 0.04% w\/v of 2-tert-butylamino-1-(4-hydroxy-3-methylphenyl)ethanol BPCRS (impurity C) and 0.048% w\/v of salbutamol sulfate BPCRS in methanol (10%).<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>(a) Use a stainless steel column (10 cm \u00d7 4.6 mm) packed with cyanosilyl silica gel for chromatography (5 \u03bcm) (Spherisorb CN 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 276 nm.<\/p>\n<p>(f) Inject 20 \u03bcL of each solution.<\/p>\n<h4>MOBILE PHASE<\/h4>\n<p>5 volumes of propan-2-ol, 30 volumes of 0.05M ammonium acetate and 65 volumes of water, adjusted to pH 4.5 with glacial acetic acid.<\/p>\n<p>When the chromatograms are recorded under the prescribed conditions, the retention time of salbutamol is about 2 minutes.<\/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 due to salbutamol and impurity C is at least 1.5.<\/p>\n<h4>DETERMINATION OF CONTENT<\/h4>\n<p>Calculate the total content of salbutamol, C13H21NO3, in the medium from the chromatograms obtained and using the declared content of C13H21NO3 in salbutamol sulfate BPCRS.<\/p>\n<h4>LIMITS<\/h4>\n<p>The amount of salbutamol 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 prepared in the mobile phase.<\/p>\n<p>(1) Disperse a quantity of the powdered tablets in sufficient mobile phase to produce a solution containing the equivalent of 0.02% w\/v of salbutamol and filter.<\/p>\n<p>(2) Dilute 1 volume of solution (1) to 100 volumes and further dilute 1 volumes of this solution to 5 volumes.<\/p>\n<p>(3) 0.02% w\/v of salbutamol for peak identification EPCRS.<\/p>\n<p>(4) 0.02% w\/v of salbutamol impurity standard BPCRS.<\/p>\n<p>(5) 0.00004% w\/v of each of salbutamol sulfate BPCRS and salbutamol impurity B BPCRS.<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>(a) Use a stainless steel column (15 cm \u00d7 3.9 mm) packed with end-capped octylsilyl silica gel for chromatography (5 \u03bcm) (Symmetry C8 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 mL per minute.<\/p>\n<p>(d) Use an ambient column temperature.<\/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) For solution (1), allow the chromatography to proceed for 25 times the retention time of salbutamol.<\/p>\n<h4>MOBILE PHASE<\/h4>\n<p>22 volumes of acetonitrile R1 and 78 volumes of a solution containing 0.287% w\/v of sodium heptanesulfonate and 0.25% w\/v of potassium dihydrogen orthophosphate adjusted to pH 3.7 with 2M orthophosphoric acid.<\/p>\n<h4>SYSTEM SUITABILITY<\/h4>\n<p>The test is not valid unless, in the chromatogram obtained with solution (5), the resolution between the peaks due to salbutamol and impurity B is at least 3.0.<\/p>\n<h4>CALCULATION OF IMPURITIES<\/h4>\n<p>For each impurity, use the concentration of salbutamol in solution (2).<\/p>\n<p>For the reporting threshold, use the concentration of salbutamol in solution (2).<\/p>\n<p>For peak identification, use solutions (3) and (4).<\/p>\n<p>Salbutamol retention time: about 3 minutes.<\/p>\n<p>Relative retention: impurity B, about 1.4; impurity D, about 2.7; impurity F, about 6.3.<\/p>\n<p>Correction factors: impurity D, multiply by 0.5.<\/p>\n<p>LIMITS<\/p>\n<p>\u2014 impurity F: not more than 0.8%;<\/p>\n<p>\u2014 impurity D: not more than 0.6%;<\/p>\n<p>\u2014 unspecified impurities: for each impurity, not more than 0.2%;<\/p>\n<p>\u2014 total impurities: not more than 2.0%;<\/p>\n<p>\u2014 reporting threshold: 0.1%.<\/p>\n<h3>Uniformity of content<\/h3>\n<p>Tablets containing less than the equivalent of 2 mg and\/or less than 2% w\/w of salbutamol comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Add 50 mL of 0.05M hydrochloric acid to one tablet, shake for 1 hour, add sufficient 0.05M hydrochloric acid to produce 100 mL, mix, centrifuge and use the supernatant liquid.<\/p>\n<p>(2) 0.0024% w\/v of salbutamol sulfate BPCRS in water.<\/p>\n<p>(3) 0.05% w\/v of 2-tert-butylamino-1-(4-hydroxy-3-methylphenyl)ethanol BPCRS (impurity C) and 0.06% w\/v of salbutamol sulfate BPCRS in the mobile phase.<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>The chromatographic conditions described under Dissolution may be used.<\/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 due to salbutamol and impurity C is at least 1.5.<\/p>\n<h4>DETERMINATION OF CONTENT<\/h4>\n<p>Calculate the content of C<sub>13<\/sub>H<sub>21<\/sub>NO<sub>3<\/sub> in each tablet using the declared content of C<sub>13<\/sub>H<sub>21<\/sub>NO<sub>3<\/sub> in salbutamol sulfate BPCRS.<\/p>\n<h2>ASSAY<\/h2>\n<p>For tablets containing the equivalent of less than 2 mg and\/or less than 2% w\/w of salbutamol<\/p>\n<p>Use the average of the individual results determined in the test for Uniformity of content.<\/p>\n<p>For tablets containing the equivalent of 2 mg or more and 2% w\/w or more of salbutamol<\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Shake 10 tablets with 100 mL of water for 1 hour, add sufficient water to produce a solution containing the equivalent of 0.04% w\/v of salbutamol, mix, centrifuge and use the supernatant liquid.<\/p>\n<p>(2) 0.048% w\/v of salbutamol sulfate BPCRS in water.<\/p>\n<p>(3) 0.04% w\/v of 2-tert-butylamino-1-(4-hydroxy-3-methylphenyl)ethanol BPCRS (impurity C) and 0.048% w\/v of salbutamol sulfate BPCRS in methanol (10%).<\/p>\n<h4>CHROMATOGRAPHIC CONDITIONS<\/h4>\n<p>The chromatographic conditions described under Dissolution may be used.<\/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 due to salbutamol and impurity C is at least 1.5.<\/p>\n<h4>DETERMINATION OF CONTENT<\/h4>\n<p>Calculate the content of salbutamol, C<sub>13<\/sub>H<sub>21<\/sub>NO<sub>3<\/sub>, in the tablets from the chromatograms obtained and using the declared content of C<sub>13<\/sub>H<sub>21<\/sub>NO<sub>3<\/sub> in salbutamol sulfate BPCRS.<\/p>\n<h2>LABELLING<\/h2>\n<p>The quantity of active ingredient is stated in terms of the equivalent amount of salbutamol.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>The impurities limited by the requirements of this monograph include impurities A, B, C, D, E, F, G, H, I, J and P listed under Salbutamol Sulfate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Action and use Beta2-adrenoceptor agonist; bronchodilator. DEFINITION Salbutamol Tablets contain Salbutamol Sulfate. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of salbutamol, C13H21NO3 95.0 to 105.0% of the stated amount. IDENTIFICATION A. In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with&#8230;<\/p>\n","protected":false},"author":4,"featured_media":20701,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20659","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\/20659","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=20659"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20659\/revisions"}],"predecessor-version":[{"id":20703,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20659\/revisions\/20703"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/20701"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20659"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20659"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20659"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}