title: Determination of potency of heparin active pharmaceutical ingredient by near infrared reflectance spectroscopy.
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.
authors.affiliation: National Glycoengineering Research Center and College of Pharmacy, Shandong University, 250012 Jinan, China.
authors.forename: Chunxiao
authors.initials: C
authors.lastname: Sun
authors.forename: Hengchang
authors.initials: H
authors.lastname: Zang
authors.forename: Xiumei
authors.initials: X
authors.lastname: Liu
authors.forename: Qin
authors.initials: Q
authors.lastname: Dong
authors.forename: Lian
authors.initials: L
authors.lastname: Li
authors.forename: Fengshan
authors.initials: F
authors.lastname: Wang
authors.forename: Linyan
authors.initials: L
authors.lastname: Sui
mesh_terms: D000465:Algorithms; D000818:Animals; D000925:Anticoagulants / Q000032:analysis* / Q000494:pharmacology; D001777:Blood Coagulation / Q000187:drug effects; D002138:Calibration; D005240:Feasibility Studies; D006041:Goats; D006493:Heparin / Q000032:analysis* / Q000494:pharmacology; D016018:Least-Squares Analysis; D011786:Quality Control; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared / Q000592:standards; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
chemical_list: D000925:Anticoagulants; D006493:Heparin