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.

journal_name

J Pharm Biomed Anal

authors

Sun C,Zang H,Liu X,Dong Q,Li L,Wang F,Sui L

doi

10.1016/j.jpba.2009.11.022

subject

Has Abstract

pub_date

2010-04-06 00:00:00

pages

1060-3

issue

5

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(09)00718-3

journal_volume

51

pub_type

杂志文章