Development of NIRS method for quality control of drug combination artesunate-azithromycin for the treatment of severe malaria.

Journal of Pharmaceutical and Biomedical Analysis
Chantal BoyerJean-Pierre Dubost

Abstract

Near infrared spectroscopy (NIRS) methods were developed for the determination of analytical content of an antimalarial-antibiotic (artesunate and azithromycin) co-formulation in hard gelatin capsule (HGC). The NIRS consists of pre-processing treatment of spectra (raw spectra and first-derivation of two spectral zones), a unique principal component analysis model to ensure the specificity and then two partial least-squares regression models for the determination content of each active pharmaceutical ingredient. The NIRS methods were developed and validated with no reference method, since the manufacturing process of HGC is basically mixed excipients with active pharmaceutical ingredients. The accuracy profiles showed β-expectation tolerance limits within the acceptance limits (±5%). The analytical control approach performed by reversed phase (HPLC) required two different methods involving two different preparation and chromatographic methods. NIRS offers advantages in terms of lower costs of equipment and procedures, time saving, environmentally friendly.

References

Apr 1, 1995·International Journal for Parasitology·A E Yeo, K H Rieckmann
Mar 4, 2000·Journal of Pharmaceutical and Biomedical Analysis·M GabriëlsJ Plaizier-Vercammen
Jan 30, 2002·The Analyst·S H Scafi, C Pasquini
Nov 4, 2004·Journal of Pharmaceutical and Biomedical Analysis·Ph HubertL Valat
Jul 14, 2007·Journal of Pharmaceutical and Biomedical Analysis·C BodsonL Delattre
Aug 24, 2007·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Y DouY L Ren
Mar 11, 2008·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·M BlancoM Bautista
Aug 16, 2008·Journal of Pharmaceutical and Biomedical Analysis·Floyd E DowellMichael D Green
Dec 23, 2008·Journal of Separation Science·Karen GaudinJean-Pierre Dubost
Jul 9, 2010·Journal of Pharmaceutical and Biomedical Analysis·E ZiémonsPh Hubert
Aug 6, 2010·International Journal of Pharmaceutics·Tina KaussPascal Millet

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Methods Mentioned

BETA
light scattering
infrared spectroscopy
electrophoresis
PCA

Software Mentioned

TQ Analyst
Omnic
Result

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