Validation of new analytical methodology for determining fenoterol hydrobromide by HPLC: application in pharmaceutical products
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Keywords

fenoterol hydrobromide
stress testing
high performance liquid chromatography
pharmaceutical drug validation

How to Cite

1.
Yano HM, Farias FF, Del Bianco MB, Garcia PL. Validation of new analytical methodology for determining fenoterol hydrobromide by HPLC: application in pharmaceutical products. Rev Inst Adolfo Lutz [Internet]. 2012 Feb. 1 [cited 2024 May 11];71(2):355-61. Available from: https://periodicos.saude.sp.gov.br/RIAL/article/view/32435

Abstract

Fenoterol hydrobromide is a β2-adrenergic agonist agent used for asthma and chronic obstructive pulmonary disease treatment. HPLC methodology was developed and validated for quantitative determination of fenoterol hydrobromide. The methodology was achieved by using a reversed-phase C18 column, (150 mm × 3.9 mm i.d., 5 μm) Thermo. The mobile phase was consisted of acetonitrile: water (30:70, v/v) with 0,1% triethylamine, pH adjusted to 5.0 with formic acid and flow rate of 1.0 mL.min-1 with UV detection at 276 nm. The concentration range was from 0.025 to 0.15 mg.mL-1, and the correlation coefficient of analytical curve was >0.999. The detection limit and the quantifying limit (QL) were 0.003 mg.mL-1 and 0.012 mg.mL-1, respectively. Intra- and interday relative standard deviations were ≤2.0%. The methodology accuracy showed the percentage mean of 99.53%. The described technique was found to be simple, rapid, precise, accurate and sensitive; the advantages over the others current methodologies are the low-cost and low-polluting conditions. Owing to its simplicity and reliable results, this methodology is suitable to be used in quality control of pharmaceutical drugs containing fenoterol hydrobromide as active component.
https://doi.org/10.53393/rial.2012.v71.32435
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