{"id":20557,"date":"2025-10-27T15:12:15","date_gmt":"2025-10-27T08:12:15","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=20557"},"modified":"2025-10-27T15:12:15","modified_gmt":"2025-10-27T08:12:15","slug":"salbutamol-nebuliser-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/salbutamol-nebuliser-solution\/","title":{"rendered":"Salbutamol Nebuliser Solution"},"content":{"rendered":"

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

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

DEFINITION<\/h2>\n

Salbutamol Nebuliser Solution is a solution of Salbutamol Sulfate in a suitable vehicle, intended to be converted into aerosols by a nebuliser.<\/p>\n

The nebuliser solution complies with the requirements stated under Preparations for Inhalation 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

A. Dilute the solution being examined with sufficient 0.1M hydrochloric acid to produce a solution containing the equivalent of 0.008% w\/v of salbutamol. The light absorption of the resulting solution, Appendix II B, in the range 230 nm to 350 nm exhibits a maximum only at 276 nm.<\/p>\n

B. In the Assay, 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

C. Dilute the solution being examined with sufficient water to produce a solution containing the equivalent of 0.025% w\/v of salbutamol. The resulting solution yields reaction A characteristic of sulfates, Appendix VI.<\/p>\n

TESTS<\/h2>\n

Acidity<\/h3>\n

pH, 3.0 to 5.0, 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 quantity of the nebuliser solution to produce a solution containing the equivalent of 0.015% w\/v of salbutamol and mix with the aid of ultrasound.<\/p>\n

(2) Dilute 1 volume of solution (1) to 50 volumes and further dilute 1 volume to 10 volumes.<\/p>\n

(3) 0.018% w\/v of salbutamol sulfate BPCRS, 0.000075% w\/v of salbutamol ketone BPCRS (impurity J) and 0.00003% w\/v of salbutamol impurity Q BPCRS.<\/p>\n

(4) 0.018% w\/v of salbutamol for peak identification EPCRS.<\/p>\n

(5) 0.018% w\/v of salbutamol impurity standard BPCRS.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n

(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octylsilyl silica gel for chromatography (3 \u03bcm) (Hypersil BDS C8 is suitable).<\/p>\n

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

(c) Use a flow rate of 1.0 mL per minute.<\/p>\n

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

(e) Use a detection wavelength of 273 nm.<\/p>\n

(f) Inject 50 \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, adjust to pH 3.0 with 10% v\/v of orthophosphoric acid.<\/p>\n

Mobile phase B 350 volumes of methanol and 650 volumes of acetonitrile.<\/p>\n\n\n\n\n\n\n\n\n\n\n
Time (Minutes)\u00a0<\/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>\n95<\/td>\n5<\/td>\nisocratic<\/td>\n<\/tr>\n
5-18<\/td>\n95\u219270<\/td>\n5\u219230<\/td>\nlinear gradient<\/td>\n<\/tr>\n
18-20<\/td>\n70<\/td>\n30<\/td>\nisocratic<\/td>\n<\/tr>\n
20-20.1<\/td>\n70\u219210<\/td>\n30\u219290<\/td>\nlinear gradient<\/td>\n<\/tr>\n
20.1-25<\/td>\n10<\/td>\n90<\/td>\nisocratic<\/td>\n<\/tr>\n
25-25.1<\/td>\n10\u219295<\/td>\n90\u21925<\/td>\nlinear gradient<\/td>\n<\/tr>\n
25.1-33<\/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 peak-to-valley ratio is at least 6.0, where Hp is the height above the baseline of the peak due to impurity J and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to salbutamol; in the chromatogram obtained with solution (2), the signal-to-noise ratio for the peak due to salbutamol is at least 30.<\/p>\n

CALCULATION OF IMPURITIES<\/h4>\n

For impurities J and Q, use the concentration of each impurity in solution (3).<\/p>\n

For all other impurities, use the concentration of salbutamol in solution (2).<\/p>\n

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

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 1, about 0.6; impurity 3, about 0.8; impurity J, about 0.95; impurity Q, about 1.4; impurity D, about 1.7; impurity N (peak 1), about 1.77; impurity N (peak 2), about 1.79; impurity F, about 1.9; impurity 2, about 2.2.<\/p>\n

Correction factors: impurity D, multiply by 1.5.<\/p>\n

LIMITS<\/h4>\n

\u2014 impurities D, F and J: for each impurity, not more than 0.5%;<\/p>\n

\u2014 impurity 1: not more than 0.4%;<\/p>\n

\u2014 impurities N (sum of peaks 1 and 2), 2 and 3: for each impurity, not more than 0.3%;<\/p>\n

\u2014 impurity Q: not more than 0.2%;<\/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 water.<\/p>\n

(1) Dilute a volume of the nebuliser solution to produce a solution containing the equivalent of 0.05% w\/v of salbutamol.<\/p>\n

(2) 0.06% w\/v of salbutamol sulfate BPCRS.<\/p>\n

(3) 0.06% w\/v of salbutamol sulfate BPCRS and 0.04% w\/v of 2-tert-butylamino-1-(4-hydroxy-3-methylphenyl)ethanol BPCRS (impurity C).<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n

(a) Use a stainless steel column (20 cm \u00d7 5 mm) packed with cyanosilyl silica gel for chromatography (5 \u03bcm) (Spherisorb CN is suitable).<\/p>\n

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

(c) Use a flow rate of 2 mL per minute.<\/p>\n

(d) Use an ambient column temperature.<\/p>\n

(e) Use a detection wavelength of 276 nm.<\/p>\n

(f) Inject 10 \u03bcL of each solution.<\/p>\n

MOBILE PHASE<\/h4>\n

5 volumes of propan-2-ol, 30 volumes of 0.05M ammonium acetate and 65 volumes of water, adjusted to pH 4.5 with dilute acetic acid.<\/p>\n

When the chromatograms are recorded under the prescribed conditions, the retention time of salbutamol is about 2 minutes.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n

The test is not valid unless:<\/p>\n

in the chromatogram obtained with solution (3), the resolution between the peaks due to salbutamol and impurity C is at least 1.5; in the chromatogram obtained with solution (2), the symmetry factor for the peak due to salbutamol is within 0.8 to 2.8.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n

Calculate the content of C13<\/sub>H21<\/sub>NO3<\/sub> in the nebuliser solution from the chromatograms obtained and using the declared content of C13<\/sub>H21<\/sub>NO3<\/sub> in salbutamol sulfate BPCRS.<\/p>\n

STORAGE<\/h2>\n

Salbutamol Nebuliser 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, J, K, M, N, O and Q listed under Salbutamol Sulfate and:<\/p>\n

\"Salbutamol<\/p>\n

1. 2,2-dihydroxy-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone (glyoxal impurity)<\/p>\n

\"Salbutamol<\/p>\n

2. 2-[4-hydroxy-3-(hydroxymethyl)benzyl]-4-{1-hydroxy-2-[(2-methyl-2-propanyl)amino]ethyl}phenol (head-to-tail dimer impurity).<\/p>\n","protected":false},"excerpt":{"rendered":"

Action and use Beta2-adrenoceptor agonist; bronchodilator. DEFINITION Salbutamol Nebuliser Solution is a solution of Salbutamol Sulfate in a suitable vehicle, intended to be converted into aerosols by a nebuliser. The nebuliser solution complies with the requirements stated under Preparations for Inhalation and with the following requirements. Content of salbutamol, C13H21NO3 95.0 to 105.0% of the…<\/p>\n","protected":false},"author":4,"featured_media":20566,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-20557","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\/20557","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=20557"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20557\/revisions"}],"predecessor-version":[{"id":20569,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/20557\/revisions\/20569"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/20566"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=20557"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=20557"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=20557"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}