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Stability indicating method development for low level calcitonin

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Abstract
Salmon calcitonin is a 32 amino acid peptide drug, therapeutically used in Paget’s disease and osteoporosis in post-menopausal women. The assay and degradation of salmon calcitonin formulated at low concentrations (400 ppm m/m) in a bioadhesive nasal powder is examined. Sample preparation was developed and optimized using Plackett-Burman and Onion designs. Best results were obtained by treating the sample with 0.45% (v/v) trifluoroacetic acid at 60°C for 40 minutes, obtaining maximum recovery of 99.63% without yielding any observable degradation. Two HPLC–UV/MS methods were developed and validated as well, showing fitness for their intended use of assay respectively degradation monitoring Pilot stability tests of the bioadhesive powder under different storage conditions showed a temperature dependent decrease in salmon calcitonin assay, with no equivalent increase in degradation products, which can be explained by the chemical interaction between calcitonin and carbomer present in the finished drug product.
Keywords
stability, assay, DOE, polymer excipients interaction, salmon calcitonin, degradation

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Chicago
D’Hondt, Matthias, Sylvia Van Dorpe, and Bart De Spiegeleer. 2010. “Stability Indicating Method Development for Low Level Calcitonin.” In Flemish Youth Conference of Chemistry, 10th, Presentations. Koninklijke Vlaamse Chemische Vereniging. Jongerensectie.
APA
D’Hondt, M., Van Dorpe, S., & De Spiegeleer, B. (2010). Stability indicating method development for low level calcitonin. Flemish Youth Conference of Chemistry, 10th, Presentations. Presented at the 10th Flemish Youth Conference of Chemistry (VJC 10), Koninklijke Vlaamse Chemische Vereniging. Jongerensectie.
Vancouver
1.
D’Hondt M, Van Dorpe S, De Spiegeleer B. Stability indicating method development for low level calcitonin. Flemish Youth Conference of Chemistry, 10th, Presentations. Koninklijke Vlaamse Chemische Vereniging. Jongerensectie; 2010.
MLA
D’Hondt, Matthias, Sylvia Van Dorpe, and Bart De Spiegeleer. “Stability Indicating Method Development for Low Level Calcitonin.” Flemish Youth Conference of Chemistry, 10th, Presentations. Koninklijke Vlaamse Chemische Vereniging. Jongerensectie, 2010. Print.
@inproceedings{888686,
  abstract     = {Salmon calcitonin is a 32 amino acid peptide drug, therapeutically used in Paget’s disease and osteoporosis in post-menopausal women. The assay and degradation of salmon calcitonin formulated at low concentrations (400 ppm m/m) in a bioadhesive nasal powder is examined.
Sample preparation was developed and optimized using Plackett-Burman and Onion designs. Best results were obtained by treating the sample with 0.45% (v/v) trifluoroacetic acid at 60°C for 40 minutes, obtaining maximum recovery of 99.63% without yielding any observable degradation.
Two HPLC–UV/MS methods were developed and validated as well, showing fitness for their intended use of assay respectively degradation monitoring
Pilot stability tests of the bioadhesive powder under different storage conditions showed a temperature dependent decrease in salmon calcitonin assay, with no equivalent increase in degradation products, which can be explained by the chemical interaction between calcitonin and carbomer present in the finished drug product.},
  author       = {D'Hondt, Matthias and Van Dorpe, Sylvia and De Spiegeleer, Bart},
  booktitle    = {Flemish Youth Conference of Chemistry, 10th, Presentations},
  keywords     = {stability,assay,DOE,polymer excipients interaction,salmon calcitonin,degradation},
  language     = {eng},
  location     = {Blankenberge, Belgium},
  pages        = {14 slides},
  publisher    = {Koninklijke Vlaamse Chemische Vereniging. Jongerensectie},
  title        = {Stability indicating method development for low level calcitonin},
  year         = {2010},
}