Determination of potency of heparin active pharmaceutical ingredient by near infrared reflectance spectroscopy

Journal of Pharmaceutical and Biomedical Analysis

Volumn 51, Issue 5, 2010, Pages 1060-1063

  Sun, Chunxiao ^a   Zang, Hengchang ^a   Liu, Xiumei ^a   Dong, Qin ^a   Li, Lian ^a   Wang, Fengshan ^a   Sui, Linyan ^b  

^a SHANDONG UNIVERSITY   (China)

^b Jin Hongli Apparatus Company of Jinan   (China)

Author keywords

Heparin API; NIRS; Potency; SG 1st derivative

Indexed keywords

HEPARIN;

ARTICLE; CALIBRATION; DRUG DETERMINATION; DRUG FORMULATION; DRUG POTENCY; DRUG QUALITY; NEAR INFRARED REFLECTANCE SPECTROSCOPY; PARTIAL LEAST SQUARES REGRESSION; PRIORITY JOURNAL;

ALGORITHMS; ANIMALS; ANTICOAGULANTS; BLOOD COAGULATION; CALIBRATION; FEASIBILITY STUDIES; GOATS; HEPARIN; LEAST-SQUARES ANALYSIS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; SPECTROSCOPY, NEAR-INFRARED; TECHNOLOGY, PHARMACEUTICAL;

EID: 72749114263     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2009.11.022     Document Type: Article

References (18)

1. Longstaff C., Whitton C.M., Stebbings R., and Gray E. How do we assure the quality of biological medicines?. Drug Discov. Today 14 (2009) 50-55
2. Li B., Suwan J., Martin J.G., Zhang F., Zhang Z., Hoppensteadt D., Clark M., Fareed J., and Linhardt R.J. Oversulfated chondroitin sulfate interaction with heparin-binding proteins: new insights into adverse reactions from contaminated heparins. Biochem. Pharmacol. 78 (2009) 292-300
3. Capila I., and Linhardt R.J. Heparin-protein interactions. Angew. Chem. Int. Ed. Engl. 41 (2002) 391-412
4. Volpi N., Maccari F., and Linhardt R.J. Capillary electrophoresis of complex natural polysaccharides. Electrophoresis 29 (2008) 3095-3106
5. Volpi N., Maccari F., and Linhardt R.J. Quantitative capillary electrophoresis determination of oversulfated chondroitin sulfate as a contaminant in heparin preparations. Anal. Biochem. 388 (2009) 140-145
6. Linhardt R.J., and Gunay N.S. Production and chemical processing of low molecular weight heparins. Semin. Thromb. Hemost. 25 (1999) 5-16
7. Luypaert J., Massart D.L., and Vander Heyden Y. Near-infrared spectroscopy applications in pharmaceutical analysis. Talanta 72 (2007) 865-883
8. Roggo Y., Chalus P., Maurer L., Lema-Martinez C., Edmond A., and Jent N. A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J. Pharm. Biomed. Anal. 44 (2007) 683-700
9. Huang Y., Tang J., Swanson B.G., Cavinato A.G., Lin M., and Rasco B.A. Near infrared spectroscopy: a new tool for studying physical and chemical properties of polysaccharide gels. Carbohydr. Polym. 53 (2003) 281-288
10. Spencer J.A., Kauffman J.F., Reepmeyer J.C., Gryniewicz C.M., Ye W., Toler D.Y., Buhse L.F., and Westenberger B.J. Screening of heparin API by near infrared reflectance and Raman spectroscopy. J. Pharm. Sci. 98 (2009) 3540-3547
11. Zhu D., Ji B., Meng C., Shi B., Tu Z., and Qing Z. The application of direct orthogonal signal correction for linear and non-linear multivariate calibration. Chemometr. Intell. Lab. Syst. 90 (2008) 108-115
12. Ni Z., Hu C., and Feng F. Progress and effect of spectral data pretreatment in NIR analytical technique. Chin. J. Pharm. Anal. 28 (2008) 824-829
13. Chen Q., Zhao J., Liu M., Cai J., and Liu J. Determination of total polyphenols content in green tea using FT-NIR spectroscopy and different PLS algorithms. J. Pharm. Biomed. Anal. 46 (2008) 568-573
14. Liu L., Huang L., Yan Y.L., and Wang Z.Y. Progress in the study of impact of scattering on stability of quantitative analysis model using near infrared spectroscopy technology and correction methods. Guang Pu Xue Yu Guang Pu Fen Xi 28 (2008) 2290-2295
15. Geladi P., MacDougall D., Martens H., and Linearization. Scatter-correction for near-infrared reflectance spectra of meat. Appl. Spectrosc. 39 (1985) 491-500
16. Barnes R.J., Dahnoa M.S., and Lister S. Standard normal variate transformation and de-trending of near-infrared diffuse reflectance spectra. Appl. Spectrosc. 43 (1989) 772-777
17. USP XX.1990, 632.
18. Zheng Y., Lai X., Bruun S.W., Ipsen H., Larsen J.N., Løwenstein H., Søndergaard I., and Jacobsen S. Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy. J. Pharm. Biomed. Anal. 46 (2008) 592-596