Abstract:
:Potency is an important parameter for evaluation of quality of heparin active pharmaceutical ingredient (API). In this paper the feasibility to determine potency of heparin API with near infrared reflectance spectroscopy (NIRS) coupled with partial least squares (PLS) algorithm is attempted. PLS factors, correlation coefficient of calibration set (R(c)), the root mean square of cross-validation (RMSECV), correlation coefficient of prediction set (R(p)) and the root mean square of prediction (RMSEP) were used to evaluate the performance of the models. The optimal calibration model was obtained with R(p)=0.9721 and RMSEP=0.55 in the 1700-1898nm spectral region when using SG-1st derivative spectral transform method and division of calibration/prediction samples was 1/1. Three other additional samples demonstrated good prediction capability of the final model and three validation samples gave good repeatability result. NIRS has the potential to be a final lot release test to be performed in a QC laboratory.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Sun C,Zang H,Liu X,Dong Q,Li L,Wang F,Sui Ldoi
10.1016/j.jpba.2009.11.022subject
Has Abstractpub_date
2010-04-06 00:00:00pages
1060-3issue
5eissn
0731-7085issn
1873-264Xpii
S0731-7085(09)00718-3journal_volume
51pub_type
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