Quantification of active ingredients in semi-solid pharmaceutical formulations by near infrared spectroscopy

Journal of Pharmaceutical and Biomedical Analysis
Lisa B SchlegelMona Abdel-Tawab

Abstract

Near infrared (NIR) spectroscopy is increasingly gaining significance in the pharmaceutical industry for quality and in-process control. However, the potential of this method for quantitative quality control in pharmacies has long been neglected and little data is available on its application in analysis of creams and ointments. This study evaluated the applicability of NIR spectrometer with limited wavelength range (1000-1900nm) for quantitative quality control of six different dermatological semi-solid pharmaceutical preparations. Each contained a frequently used active ingredient in a common concentration either in a water-free lipid base or in an aqueous cream matrix. Based on direct NIR transflectance measurements through standardized glass beakers and partial least squares (PLS) multivariate calibration, quantitative models were generated comparing several data pre-processing methods Whereas difficulties were observed for mixtures containing 2% (w/w) metronidazole or 4% (w/w) erythromycin, content determination was possible with sufficient accuracy for salicylic acid (5 % (w/w)) and urea (10% (w/w)) in hydrophilic as well as in lipophilic formulations meeting the limit of a maximum deviation of±5% (relative) from the refe...Continue Reading

Citations

Jan 3, 2021·Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy·Xuefen SunChao Chen
Aug 28, 2021·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Alessandra BiancolilloFederico Marini

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