{"id":20571,"date":"2025-10-27T15:35:26","date_gmt":"2025-10-27T08:35:26","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=20571"},"modified":"2025-11-15T17:12:55","modified_gmt":"2025-11-15T10:12:55","slug":"salbutamol-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/salbutamol-oral-solution\/","title":{"rendered":"Salbutamol Oral Solution"},"content":{"rendered":"

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

Beta2<\/sub>-adrenoceptor agonist; bronchodilator.<\/p>\n

DEFINITION<\/h2>\n

Salbutamol Oral Solution is a solution of Salbutamol Sulfate in a suitable flavoured vehicle.<\/p>\n

The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/p>\n

Content of salbutamol, C13<\/sub>H21<\/sub>NO3<\/sub><\/strong><\/p>\n

95.0 to 105.0% of the stated amount.<\/p>\n

IDENTIFICATION<\/h2>\n

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

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

TESTS<\/h2>\n

Acidity<\/h3>\n

pH, 3.3 to 4.0, Appendix V L.<\/p>\n

Related substances<\/h3>\n

Carry out the method for liquid chromatography, Appendix III D, using the following solutions, prepared in mobile phase A.<\/p>\n

(1) Dilute a volume of the oral solution to produce a solution containing the equivalent of 0.01% w\/v of salbutamol.<\/p>\n

(2) Dilute 1 volume of solution (1) to 200 volumes.<\/p>\n

(3) 0.012% w\/v of salbutamol sulfate BPCRS, 0.00005% w\/v each of salbutamol ketone BPCRS (impurity J) and
\nsalbutamol impurity Q BPCRS.<\/p>\n

(4) 0.012% w\/v of salbutamol for peak identification EPCRS.<\/p>\n

(5) 0.012% w\/v of salbutamol impurity standard BPCRS.<\/p>\n

(6) Dilute 1 volume of solution (2) to 5 volumes.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n

(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octylsilyl silica gel for chromatography (3 \u03bcm) (Luna C-8 is suitable).<\/p>\n

(b) Use gradient elution and the mobile phase described below.<\/p>\n

(c) Use a flow rate as described below.<\/p>\n

(d) Use a column temperature of 30\u00b0.<\/p>\n

(e) Use a detection wavelength of 225 nm.<\/p>\n

(f) Inject 40 \u03bcL of each solution.<\/p>\n

MOBILE PHASE<\/h4>\n

Mobile phase A 0.5 volumes of triethylamine and 1000 volumes of 0.025M sodium dihydrogen orthophosphate, adjusted to pH 3.0 with 10% v\/v of orthophosphoric acid.<\/p>\n

Mobile phase B 35 volumes of methanol and 65 volumes of acetonitrile.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Time (Minutes)\u00a0<\/strong><\/td>\nFlow rate (mL\/min)<\/strong><\/td>\nMobile phase A (% v\/v)\u00a0<\/strong><\/td>\nMobile phase B (% v\/v)\u00a0<\/strong><\/td>\nComment<\/strong><\/td>\n<\/tr>\n
0-5<\/td>\n1.0<\/td>\n95<\/td>\n5<\/td>\nisocratic<\/td>\n<\/tr>\n
5-10<\/td>\n1.0<\/td>\n95\u219290<\/td>\n5\u219210<\/td>\nlinear gradient<\/td>\n<\/tr>\n
10-25<\/td>\n1.0\u21921.5<\/td>\n90<\/td>\n10<\/td>\nisocratic<\/td>\n<\/tr>\n
25-45<\/td>\n1.5<\/td>\n90<\/td>\n10<\/td>\nisocratic<\/td>\n<\/tr>\n
45-45.1<\/td>\n1.5<\/td>\n0\u219210<\/td>\n10\u219290<\/td>\nlinear gradient<\/td>\n<\/tr>\n
45.1-47.0<\/td>\n1.5<\/td>\n10<\/td>\n90<\/td>\nisocratic<\/td>\n<\/tr>\n
47.0-47.1<\/td>\n1.5<\/td>\n10\u219295<\/td>\n90\u21925<\/td>\nlinear gradient<\/td>\n<\/tr>\n
47.1-55.0<\/td>\n1.5<\/td>\n95<\/td>\n5<\/td>\nre-equilibration<\/td>\n<\/tr>\n
55.0-55<\/td>\n1.5\u21921.0<\/td>\n95<\/td>\n5<\/td>\nre-equilibration<\/td>\n<\/tr>\n
55.1-60.0<\/td>\n1.0<\/td>\n95<\/td>\n5<\/td>\nre-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

SYSTEM SUITABILITY<\/h4>\n

The test is not valid unless: in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity J and salbutamol is at
\nleast 1.2; in the chromatogram obtained with solution (6), the signal-to-noise ratio for the peak due to salbutamol is at least 30.<\/p>\n

CALCULATION OF IMPURITIES<\/h4>\n

For each impurity, use the concentration of salbutamol in solution (2).<\/p>\n

For the reporting threshold, use the concentration of salbutamol in solution (6). For impurity N, apply the reporting threshold to the sum of impurity N peaks 1 and 2.<\/p>\n

For peak identification, use solutions (3), (4) and (5).<\/p>\n

Salbutamol retention time: about 8 minutes.<\/p>\n

Relative retention: impurity J, about 0.9; impurity Q, about 1.7; impurity D, about 2.4; impurity N (peak 1), about 3.1; impurity N (peak 2), about 3.2; impurity O, about 3.3 and impurity F, about 3.8.<\/p>\n

Correction factors: impurity F, multiply by 0.3; impurity N, multiply by 0.6; impurity O, multiply by 0.3; impurity Q, multiply by 2.4.<\/p>\n

LIMITS<\/h4>\n

\u2014 impurities D and F: for each impurity, not more than 0.6%;<\/p>\n

\u2014 impurities J, N (sum of peaks 1 and 2), O and Q: for each impurity, not more than 0.3%;<\/p>\n

\u2014 unspecified impurities: for each impurity, not more than 0.2%;<\/p>\n

\u2014 total impurities: not more than 2.0%;<\/p>\n

\u2014 reporting threshold: 0.1%.<\/p>\n

ASSAY<\/h2>\n

Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared in the mobile phase.<\/p>\n

(1) Dilute a weighed amount of the oral solution to produce a solution containing the equivalent of 0.01% w\/v of salbutamol.<\/p>\n

(2) 0.012% w\/v of salbutamol sulfate BPCRS.<\/p>\n

(3) 0.012% w\/v of salbutamol sulfate BPCRS and 0.00005% w\/v of salbutamol ketone BPCRS (impurity J).<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n

The chromatographic conditions described under Related substances may be used.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity J and salbutamol is at least 1.2.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n

Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C13<\/sub>H21<\/sub>NO3<\/sub>, weight in volume, using the declared content of C13<\/sub>H21<\/sub>NO3<\/sub> in salbutamol sulfate BPCRS.<\/p>\n

STORAGE<\/h2>\n

Salbutamol Oral Solution should be protected from light.<\/p>\n

LABELLING<\/h2>\n

The quantity of active ingredient is stated in terms of the equivalent amount of salbutamol.<\/p>\n

IMPURITIES<\/h2>\n

The impurities limited by the requirements of this monograph include impurity C, D, F, I, J, K, M, N, O and Q listed under Salbutamol Sulfate.<\/p>\n","protected":false},"excerpt":{"rendered":"

Action and use Beta2-adrenoceptor agonist; bronchodilator. DEFINITION Salbutamol Oral Solution is a solution of Salbutamol Sulfate in a suitable flavoured vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of salbutamol, C13H21NO3 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay, record the UV…<\/p>\n","protected":false},"author":4,"featured_media":20614,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20571","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\/20571","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=20571"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20571\/revisions"}],"predecessor-version":[{"id":20618,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20571\/revisions\/20618"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/20614"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20571"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20571"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20571"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}