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Abstract
A size exclusion liquid chromatography (SE-LC) method was validated for the determination of erythropoietin in pharmaceutical formulations without serum albumin. The LC method was carried out on a BioSep-SEC-S 2000 column (300 mm × 7.8 mm I.D.) using photodiode array (PDA) detection at 214 nm. The mobile phase consisted of 0.001 M monobasic potassium phosphate, 0.008 M dibasic sodium phosphate, and 0.2 M sodium chloride buffer, pH 7.4, run isocratically at a flow rate of 0.5 mL/min. The chromatographic separation was obtained with retention time of 14.5 min, and was linear in the range of 5–150 µg/mL (r 2 = 0.9991). The accuracy was 101.07% with bias lower than 1.36%. The limits of detection and quantitation were 0.28 and 1 µg/mL, respectively. Moreover, method validation demonstrated acceptable results for precision and robustness. The proposed method was applied for the analysis of the erythropoietin in pharmaceutical dosage forms, and the content/potencies correlated to the bioassay, contributing to establish alternatives which improve the quality control, assuring the therapeutic efficacy.
ACKNOWLEDGMENT
The authors wish to thank CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico), project 475029/2007-0 and CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior) for the financial support.
Notes
a Mean of three replicates.
b RSD = Relative standard deviation.
a Mean of three replicates.
b RSD = Relative standard deviation.
c Bias = [(Measured concentration − Nominal concentration)/Nominal concentration] × 100.
a Mean of three replicates.
b RSD = Relative standard deviation.
a Mean of three replicates.
b SD = Standard deviation.
a Non-significant difference (P > 0.05).
b Mean of three replicates.
c SD = Standard deviation.