Multivariate Control Charts for Simultaneous Quality Monitoring ofIsoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable NearInfrared Spectrometer

Journal of the Brazilian Chemical Society

Fernanda S. L. Costa¹  Ricardo H. P. Pedroza¹  Dayanne L. Porto¹  Marcelo V. P. Amorim¹  Kássio M. G. Lima¹ 

关键词: multivariate control chart;    principal component analysis;    net analyte signal;    process analyte technology;    near infrared spectroscopy;   

DOI  :  10.5935/0103-5053.20140214

来源: SciELO

【 摘 要 】

One of the keys to maintain high manufacturing quality improvement is the use ofcontrol charts. In this work, multivariate control charts based on significantprincipal component (PC) scores and net analytical signal (NAS) were developed tosimultaneously monitor the quality of two active pharmaceutical ingredients (API)(isoniazid and rifampicin) in pharmaceutical formulation (laboratory samples andproduction samples) using a portable near infrared spectrometer. The limits for bothmultivariate charts were estimated using the quality specifications from thepharmaceutical formulation (± 5% of the nominal content of each API). The use ofthese multivariate control charts has provided a simple and powerful tool to evaluatethe content of pharmaceutical formulations based on isoniazid and rifampicin capsulescombined with near infrared spectroscopy. The procedure is rapid and adjustable formonitoring the production of the pharmaceutical preparations produced at UFRN/Braziltoward the process analytical technology (PAT) for the treatment of pulmonarytuberculosis.

【 授权许可】

CC BY   
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