Quantitative analysis of diphenhydramine hydrochloride in pharmaceutical wafers using near infrared and Raman spectroscopy

• Published in: Analytical and bioanalytical chemistry Vol. 395; no. 6; pp. 1777 - 1785
• Main Authors: Haag, Maren, Brüning, Michael, Molt, Karl
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Berlin/Heidelberg : Springer-Verlag 01.11.2009; Springer-Verlag
• Subjects: Active pharmaceutical ingredient (API) quantification; Analytical Chemistry; Biochemistry; Calibration; Characterization and Evaluation of Materials; Chemistry; Chemistry and Materials Science; crystallization; Diphenhydramine - chemistry; Dosage Forms; Food Science; Hydrochlorides; Infrared; Ingredients; Laboratory Medicine; Mathematical models; Monitoring/Environmental Analysis; near-infrared spectroscopy; Original Paper; Pharmaceutical Preparations - chemistry; Pharmaceutical wafers; Pharmaceuticals; Process analytical technology (PAT); Quantitative analysis; Raman spectroscopy; Spectroscopy, Near-Infrared - methods; Spectrum Analysis, Raman - methods; Thin strips; Wafers; Near infrared spectroscopy; Active pharmaceutical ingredient (API) quantification; Process analytical technology (PAT); Pharmaceutical wafers; Thin strips; Crystallization; Raman spectroscopy
• ISSN: 1618-2642; 1618-2650
• DOI: 10.1007/s00216-009-3130-0

Wafers with varying concentrations of diphenhydramine hydrochloride (DPH-HCl) as active pharmaceutical ingredient (API) were prepared and their near infrared (NIR) and Raman spectra recorded. The purpose of this study was to compare the suitability of these two vibrational spectroscopic techniques for the quantification of DPH-HCl in pharmaceutical wafers. Partial least squares (PLS1) calibration models with different data pretreatments were tested. Both NIR and Raman spectroscopy proved to be suitable to predict DPH-HCl contents at lower concentration ranges. At higher concentrations, interference by crystallization processes was observed. For investigating the general applicability of the quantification methods, two commercially available products were examined.