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KMID : 0369820090390050353
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Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 5 p.353 ~ p.357
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Stability of Octreotide Acetate in Aqueous Solutions and PLGA Films
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Ryu Ki-Won
Na Dong-Hee
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Abstract
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As a synthetic analog of the naturally occurring hormone somatostatin, octreotide has been commercially formulated in poly(lactide-co-glycolide) (PLGA) microspheres for the treatment of acromegaly. The purpose of this study was to evaluate stability of octreotide acetate in aqueous solutions at various pH values and PLGA films. Stability-indicating reversed-phase high-performance liquid chromatographic method was developed with good precision and accuracy, and it was applied to the stability studies. In aqueous solutions at pH 2.5-9.0, the degradation of octreotide followed approximately first order kinetics and the most favorable stability was found at pH 4. In PLGA films, the formation of acylated octreotides reached approximately 55% of the released octreotides. Various acylated octreotides was structurally identified by liquid chromatography-mass spectrometric analysis.
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KEYWORD
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Octreotide, Stability, PLGA
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