Acoustic-resonance spectrometry as a process analytical technology for the quantification of active pharmaceutical ingredient in semi-solids

Abstract

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).

Integrated Sensing and Processing Acoustic Resonance Spectrometry (ISP-ARS) for Sample Classification

“…To illustrate the differences between ARS and ISP-ARS in a quantitative fashion, the bootstrap error-adjusted single sample technique (BEST), a nonparametric cluster algorithm, was used to calculate multidimensional standard deviations (MSD) between clusters [15]. Table 1 reports the MSDs calculated from the ARS, using the full spectral region spanning 14-17 KHz.…”

“…Versatility and Flexibility of ISP-ARS ARS has previously been applied to the study of tablets [13][14], semisolids, and colloidal dispersions [15][16], liquids [17][18][19], and powders [20][21][22]. Clearly, ARS can be used for the analysis of samples in many phases.…”

“…A detailed description of the basic AR spectrometer components has appeared elsewhere [14][15]. The new ISP-ARS used in this research encoded the excitation signal (ISP waveform) in such a way that the detector automatically output the classification of each fuel premix as a unique voltage.…”

Real time acquisition and frequency domain analysis of acoustic patterns of fluids for applications in the field of homeland security

“…[9]- [11]. The method has accurately differentiated as well as quantified sample analytes in various forms such as tablets, powders and liquids.…”

Real-Time Analysis for Quality Control of a Reaction Process using Ultra-high Performance Liquid Chromatography. Reduction of Phenyl Ketone to Phenyl Alcohol

“…As such, Process Analytical Technology (PAT) has been introduced in the pharmaceutical industry, where many analytical methods have been examined as potential PAT tools. The ability of near-infrared spectroscopy to analyze solid samples without pretreatment has resulted in its extensive application [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17]. In contrast, chromatographic techniques, such as high-performance liquid chromatography (HPLC), have not become popular in PAT because of labor-intensive sample preparations and long run times.…”