Titre du document / Document title

Determination of albuterol sulfate and its related substances in albuterol sulfate inhalation solution, 0.5% by RP-HPLC

Auteur(s) / Author(s)

ERRAM Satyajit V. ⁽¹⁾ ; FANSKA Cindy B. ⁽¹⁾ ; ASIF Muhammad ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Analytical Development, Dey L.P, Napa, CA 94558, ETATS-UNIS

Résumé / Abstract

An isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated forthe determination ofalbuterol sulfate and six of its related substances in albuterol sulfate inhalation solution, 0.5% (w/v). The separation was achieved using a YMC phenyl column (250 mm x 4.6mm ID, 5 μm fitted with a direct connect YMC phenyl guard column (20mm x 4mm ID) maintained at ambient conditions, and a mobile phase of 25 mM monobasic potassium phosphate (pH 3.0) and methanol (95:5, v/v). The mobile phase flow rate was 1.5 mL/min and the detection wavelength was 225 nm. Albuterol is quantitated versus an external standard. The method was capable of resolving six of the seven known albuterol-related substances. Bis-ether albuterol, a drug substance process related impurity, is retained on the column due to its different hydrophilic character. The related substances are determined by area percent. However, a correction factor of 1.6 is applied for the determination of albuterol aldehyde, a potential impurity and a degradation product, since its molar absorptivity is about 1.6 times that of albuterol. The limits of detection and quantitation for albuterol and six of its related substances ranged between 0.01 and 0.21% of the assay concentration of 0.3 mg/mL as albuterol base. The method was found to be linear for albuterol over the range of 50-150% of the active label claim. The method was also found to be linear for the six related substances over the range 0.05-0.5%. No interferences from the blank, placebo (formulation matrix), related substances or force-degraded placebo samples were observed for the determination of the active or the individual related substances. The method was found to be accurate, precise, linear, specific, sensitive, rugged, robust, and stability-indicating.

Revue / Journal Title

Journal of pharmaceutical and biomedical analysis   ISSN 0731-7085   CODEN JPBADA 

Source / Source

2006, vol. 40, n^o4, pp. 864-874 [11 page(s) (article)] (11 ref.)

Langue / Language

Anglais

Editeur / Publisher

Elsevier Science, Amsterdam, PAYS-BAS  (1983) (Revue)

Mots-clés anglais / English Keywords

β-Adrenergic receptor agonist ; β2-Adrenergic receptor ; Agonist ; Bronchodilator ; HPLC chromatography ; Inhalation ; Sulfates ; Salbutamol ; Quantitative analysis ;

Mots-clés français / French Keywords

Stimulant β-adrénergique ; Récepteur β2-adrénergique ; Agoniste ; Bronchodilatateur ; Chromatographie HPLC ; Inhalation ; Sulfate ; Salbutamol ; Analyse quantitative ;

Mots-clés espagnols / Spanish Keywords

Estimulante β-adrenérgico ; Receptor β2-adrenérgico ; Agonista ; Broncodilatador ; Cromatografía HPLC ; Inhalación ; Sulfato ; Salbutamol ; Análisis cuantitativo ;

Mots-clés d'auteur / Author Keywords

Albuterol sulfate ; Related substances ; RP-HPLC ; HPLC: Assay ; Validation ;

Localisation / Location

INIST-CNRS, Cote INIST : 19962, 35400013308292.0070