Acoustic-resonance spectrometry as a process analytical technology for the quantification of active pharmaceutical ingredient in semi-solids.
The purpose of this study was to demonstrate acoustic resonance spectrometry (ARS) as an alternative process analytical technology to near infrared (NIR) spectroscopy for the quantification of active pharmaceutical ingredient (API) in semi-solids such as creams, gels, ointments, and lotions. The ARS used for this research was an inexpensive instrument constructed from readily available parts. Acoustic-resonance spectra were collected with a frequency spectrum from 0 to 22.05 KHz. NIR data were collected from 1100 to 2500 nm. Using 1-point net analyte signal (NAS) calibration, NIR for the API (colloidal oatmeal [CO]) gave an r2 prediction accuracy of 0.971, and a standard error of performance (SEP) of 0.517%CO. ARS for the API resulted in an r2 of 0.983 and SEP of 0.317%CO. NAS calibration is compared with principal component regression. This research demonstrates that ARS can sometimes outperform NIR spectrometry and can be an effective analytical method for the quantification of API in semi-solids. ARS requires no sample preparation, provides larger penetration depths into lotions than optical techniques, and measures API concentrations faster and more accurately. These results suggest that ARS is a useful process analytical technology (PAT).
Medendorp
Joseph
J
Department of Pharmaceutical Sciences, College of Pharmacy, A123 ASTeCC Building, Lexington, KY 40536-0286, USA.
Buice
Robert G
RG
Lodder
Robert A
RA
D000162:Acoustics; D019411:Clinical Laboratory Techniques; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011208:Powders / Q000737:chemistry; D013057:Spectrum Analysis / Q000379:methods; D013607:Tablets / Q000737:chemistry; D013678:Technology, Pharmaceutical
D004364:Pharmaceutical Preparations; D011208:Powders; D013607:Tablets