Medendorp Joseph, Buice Robert G, Lodder Robert A
Department of Pharmaceutical Sciences, College of Pharmacy, A123 ASTeCC Building, 40536-0286, Lexington, KY.
Chattem Inc, 1715 West 38th Street, 37409, Chattanooga, TN.
AAPS PharmSciTech. 2006 Sep;7(3):E22-E29. doi: 10.1208/pt070359. Epub 2017 Mar 8.
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 ingradient (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 anr prediction accuracy of 0.971, and a standard error of performance (SEP) of 0.517%CO. ARS for the API resulted in anr 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).
本研究的目的是证明声共振光谱法（ARS）可作为一种替代过程分析技术，用于替代近红外（NIR）光谱法，以定量测定乳膏、凝胶、软膏和洗剂等半固体制剂中的活性药物成分（API）。本研究中使用的ARS是一种由易于获得的部件构建而成的廉价仪器。在0至22.05千赫兹的频谱范围内收集声共振光谱。近红外数据在1100至2500纳米范围内收集。使用单点净分析物信号（NAS）校准，API（胶体燕麦片[CO]）的近红外预测准确度为0.971，性能标准误差（SEP）为0.517%CO。API的ARS结果显示预测准确度为0.983，SEP为0.317%CO。将NAS校准与主成分回归进行比较。本研究表明，ARS有时可优于近红外光谱法，并且可以成为定量测定半固体制剂中API的有效分析方法。ARS无需样品制备，与光学技术相比，对洗剂具有更大的穿透深度，并且能够更快、更准确地测量API浓度。这些结果表明，ARS是一种有用的过程分析技术（PAT）。
