Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride

Derivative spectrophotometry – interlaboratory method transfer in pharmaceutical analysis. [Display omitted] •Inter-laboratory verification of derivative spectrophotometry method-EP monograph.•Resolution power–amplitude A/B ratio through instrumental and algorithm’s parameters.•Algorithm’s parameter...

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Published in:	Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy Vol. 150; pp. 792 - 798
Main Authors:	Marković, Bojan, Ignjatović, Janko, Vujadinović, Mirjana, Savić, Vedrana, Vladimirov, Sote, Karljiković-Rajić, Katarina
Format:	Journal Article
Language:	English
Published:	England Elsevier B.V 05.11.2015
Subjects:	Acetylation Algorithms Chitosan - chemistry Chitosan hydrochloride-degree of deacetylation Derivative spectrophotometry (DS) European pharmacopoeia (EP) Instrumental and algorithm’s parameters Method transfer Resolution power parameter the amplitude A/B ratio Spectrophotometry Spectrophotometry, Ultraviolet European pharmacopoeia (EP) Chitosan hydrochloride-degree of deacetylation Method transfer Resolution power parameter the amplitude A/B ratio Instrumental and algorithm’s parameters Derivative spectrophotometry (DS)
ISSN:	1386-1425, 1873-3557, 1873-3557
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Abstract	Derivative spectrophotometry – interlaboratory method transfer in pharmaceutical analysis. [Display omitted] •Inter-laboratory verification of derivative spectrophotometry method-EP monograph.•Resolution power–amplitude A/B ratio through instrumental and algorithm’s parameters.•Algorithm’s parameter smoothing points (SP) 7 required for verification.•Chitosan hydrochloride-degree of deacetylation (1D202; SP 9; 2nd polynomial degree).•Accepted criteria up to 2% or 3% between averages for method transfer. 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 (±3%) 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 1D202; 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.
AbstractList	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 (±3%) 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 (1)D202; 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.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 (±3%) 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 (1)D202; 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. Derivative spectrophotometry – interlaboratory method transfer in pharmaceutical analysis. [Display omitted] •Inter-laboratory verification of derivative spectrophotometry method-EP monograph.•Resolution power–amplitude A/B ratio through instrumental and algorithm’s parameters.•Algorithm’s parameter smoothing points (SP) 7 required for verification.•Chitosan hydrochloride-degree of deacetylation (1D202; SP 9; 2nd polynomial degree).•Accepted criteria up to 2% or 3% between averages for method transfer. 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 (±3%) 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 1D202; 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. 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 (±3%) 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 (1)D202; 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.
Author	Vujadinović, Mirjana Marković, Bojan Savić, Vedrana Vladimirov, Sote Karljiković-Rajić, Katarina Ignjatović, Janko
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Keywords	European pharmacopoeia (EP) Chitosan hydrochloride-degree of deacetylation Method transfer Resolution power parameter the amplitude A/B ratio Instrumental and algorithm’s parameters Derivative spectrophotometry (DS)
Language	English
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Snippet	Derivative spectrophotometry – interlaboratory method transfer in pharmaceutical analysis. [Display omitted] •Inter-laboratory verification of derivative... Inter-laboratory verification of European pharmacopoeia (EP) monograph on derivative spectrophotometry (DS) method and its application for chitosan...
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SubjectTerms	Acetylation Algorithms Chitosan - chemistry Chitosan hydrochloride-degree of deacetylation Derivative spectrophotometry (DS) European pharmacopoeia (EP) Instrumental and algorithm’s parameters Method transfer Resolution power parameter the amplitude A/B ratio Spectrophotometry Spectrophotometry, Ultraviolet
Title	Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride
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