Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride
Authorized Users Only
2015
Authors
Marković, Bojan
Ignjatović, Janko

Vujadinović, Mirjana
Savić, Vedrana
Vladimirov, Sote
Karljiković-Rajić, Katarina

Article (Published version)

Metadata
Show full item recordAbstract
Inter-laboratory verification of European pharmacopoeia (EP) monograph on derivative spectrophotometry (DS) method and its application for chitosan hydrochloride was carried out on two generation of instruments (earlier GBC Cintra 20 and current technology TS Evolution 300). Instruments operate with different versions of Savitzky-Golay algorithm and modes of generating digital derivative spectra. For resolution power parameter, defined as the amplitude ratio A/B in DS method EP monograph, comparable results were obtained only with algorithm's parameters smoothing points (SP) 7 and the 2nd degree polynomial and those provided corresponding data with other two modes on TS Evolution 300 Medium digital indirect and Medium digital direct. Using quoted algorithm's parameters, the differences in percentages between the amplitude ratio A/B averages, were within accepted criteria (+/- 13%) for assay of drug product for method transfer. The deviation of 1.76% for the degree of deacetylation asse...ssment of chitosan hydrochloride, determined on two instruments, (amplitude D-1(202); the 2nd degree polynomial and SP 9 in Savitzky-Golay algorithm), was acceptable, since it was within allowed criteria (+/- 2%) for assay deviation of drug substance, for method transfer in pharmaceutical analyses.
Source:
Spectroscopy Letters, 2015, 150, 792-798Publisher:
- Pergamon-Elsevier Science Ltd, Oxford
Funding / projects:
DOI: 10.1016/j.saa.2015.06.022
ISSN: 1386-1425
PubMed: 26112102
WoS: 000361774900093
Scopus: 2-s2.0-84934946333
Collections
Institution/Community
PharmacyTY - JOUR AU - Marković, Bojan AU - Ignjatović, Janko AU - Vujadinović, Mirjana AU - Savić, Vedrana AU - Vladimirov, Sote AU - Karljiković-Rajić, Katarina PY - 2015 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2323 AB - Inter-laboratory verification of European pharmacopoeia (EP) monograph on derivative spectrophotometry (DS) method and its application for chitosan hydrochloride was carried out on two generation of instruments (earlier GBC Cintra 20 and current technology TS Evolution 300). Instruments operate with different versions of Savitzky-Golay algorithm and modes of generating digital derivative spectra. For resolution power parameter, defined as the amplitude ratio A/B in DS method EP monograph, comparable results were obtained only with algorithm's parameters smoothing points (SP) 7 and the 2nd degree polynomial and those provided corresponding data with other two modes on TS Evolution 300 Medium digital indirect and Medium digital direct. Using quoted algorithm's parameters, the differences in percentages between the amplitude ratio A/B averages, were within accepted criteria (+/- 13%) for assay of drug product for method transfer. The deviation of 1.76% for the degree of deacetylation assessment of chitosan hydrochloride, determined on two instruments, (amplitude D-1(202); the 2nd degree polynomial and SP 9 in Savitzky-Golay algorithm), was acceptable, since it was within allowed criteria (+/- 2%) for assay deviation of drug substance, for method transfer in pharmaceutical analyses. PB - Pergamon-Elsevier Science Ltd, Oxford T2 - Spectroscopy Letters T1 - Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride VL - 150 SP - 792 EP - 798 DO - 10.1016/j.saa.2015.06.022 ER -
@article{ author = "Marković, Bojan and Ignjatović, Janko and Vujadinović, Mirjana and Savić, Vedrana and Vladimirov, Sote and Karljiković-Rajić, Katarina", year = "2015", abstract = "Inter-laboratory verification of European pharmacopoeia (EP) monograph on derivative spectrophotometry (DS) method and its application for chitosan hydrochloride was carried out on two generation of instruments (earlier GBC Cintra 20 and current technology TS Evolution 300). Instruments operate with different versions of Savitzky-Golay algorithm and modes of generating digital derivative spectra. For resolution power parameter, defined as the amplitude ratio A/B in DS method EP monograph, comparable results were obtained only with algorithm's parameters smoothing points (SP) 7 and the 2nd degree polynomial and those provided corresponding data with other two modes on TS Evolution 300 Medium digital indirect and Medium digital direct. Using quoted algorithm's parameters, the differences in percentages between the amplitude ratio A/B averages, were within accepted criteria (+/- 13%) for assay of drug product for method transfer. The deviation of 1.76% for the degree of deacetylation assessment of chitosan hydrochloride, determined on two instruments, (amplitude D-1(202); the 2nd degree polynomial and SP 9 in Savitzky-Golay algorithm), was acceptable, since it was within allowed criteria (+/- 2%) for assay deviation of drug substance, for method transfer in pharmaceutical analyses.", publisher = "Pergamon-Elsevier Science Ltd, Oxford", journal = "Spectroscopy Letters", title = "Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride", volume = "150", pages = "792-798", doi = "10.1016/j.saa.2015.06.022" }
Marković, B., Ignjatović, J., Vujadinović, M., Savić, V., Vladimirov, S.,& Karljiković-Rajić, K.. (2015). Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride. in Spectroscopy Letters Pergamon-Elsevier Science Ltd, Oxford., 150, 792-798. https://doi.org/10.1016/j.saa.2015.06.022
Marković B, Ignjatović J, Vujadinović M, Savić V, Vladimirov S, Karljiković-Rajić K. Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride. in Spectroscopy Letters. 2015;150:792-798. doi:10.1016/j.saa.2015.06.022 .
Marković, Bojan, Ignjatović, Janko, Vujadinović, Mirjana, Savić, Vedrana, Vladimirov, Sote, Karljiković-Rajić, Katarina, "Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride" in Spectroscopy Letters, 150 (2015):792-798, https://doi.org/10.1016/j.saa.2015.06.022 . .