A fluorescence-based assay for octreotide in kinetic release from depot formulations

Abstract

Recebido em 2/8/11; aceito em 25/11/11; publicado na web em 28/2/12Here we report the validation of a derivatization method that makes use of fluorescamine as a selective reactant for the quantitative analysis of peptide and protein drugs in the dissolution profile from depot formulations. Typical current methods require separation of the nano/microparticles and time-consuming chromatographic runs. In this study we report a method which can be conducted without the need for complete physical separation of the particles or removal of the unreacted probe. This method was used here for the analysis of the release profile of octreotide in a depot formulation, with results in excellent agreement with reported chromatographic assays.

Sustained release and pharmacologic effects of human glucagon-like peptide-1 and liraglutide from polymeric microparticles

“…The quantification of the peptides was performed by derivatization with fluorescamine and fluorimetric analysis (Guerreiro et al, 2012b;Udenfriend et al, 1972). Briefly, an analytical curve (between 0.4 and 0.0065 µg/µL) was performed by using the respective peptide (either liraglutide or hGLP-1) as standards.…”

Facile spectrofluorimetric quantitation of octreotide, a synthetic peptide, in its pure form and pharmaceutical formulation; evaluation of the method’s greenness

“…There are not a large number of analytical methods for determining octreotide in its pure form and pharmaceutical formulation. These methods include high‐performance liquid chromatography, [ 9–11 ] liquid chromatography, [ 12–14 ] electrophoresis, [ 15 ] proton ( 1 H) quantitative nuclear magnetic resonance, [ 16 ] spectrofluorimetry, [ 17 ] and voltammetry. [ 18 ]…”

“…[4][5][6][7][8] There are not a large number of analytical methods for determining octreotide in its pure form and pharmaceutical formulation. These methods include high-performance liquid chromatography, [9][10][11] liquid chromatography, [12][13][14] electrophoresis, [15] proton ( 1 H) quantitative nuclear magnetic resonance, [16] spectrofluorimetry, [17] and voltammetry. [18] Generally, direct spectrofluorimetric methods based primarily on the measurement of the native drug fluorescence are of great interest.…”

“…[17] The proposed method is simpler as there is no need for multiple steps, is more rapid, and has a higher sensitivity with good linearity. However, the previously reported spectrofluorimetric method [17] is based on the derivatization of octreotide with fluorescamine reagent which is highly expensive; in addition, the different factors that may affect the fluorescence were not optimized in the published work. Torell and Stenhagen buffer has been prepared in a pH range 2.0-12.0 by mixing NaOH (1 M) with citric and phosphoric acids, then treated with 0.1 M HCl to obtain the appropriate pH.…”