Quantification of active ingredients in semi-solid pharmaceutical formulations by near infrared spectroscopy
| Autor: | Lisa Schlegel, Manfred Schubert-Zsilavecz, Mona Abdel-Tawab |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Drug Compounding
Clinical Biochemistry Analytical chemistry Pharmaceutical Science 02 engineering and technology 01 natural sciences Analytical Chemistry Matrix (chemical analysis) Metronidazole Drug Discovery Partial least squares regression Least-Squares Analysis Spectroscopy Active ingredient Spectroscopy Near-Infrared Chromatography Spectrometer Chemistry Content determination 010401 analytical chemistry Near-infrared spectroscopy 021001 nanoscience & nanotechnology 0104 chemical sciences Aqueous cream Pharmaceutical Preparations Calibration 0210 nano-technology |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 142:178-189 |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/j.jpba.2017.04.048 |
| Popis: | 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 reference values. Exemplarily, one of the methods was successfully validated according to the EMA Guideline, determining several figures of merit such as specificity, linearity, accuracy, precision and robustness. |
| Databáze: | OpenAIRE |
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