Yeung David Yong-Hoi, Lee Tony, Grant Gail, Ma Minhui, Kwong Elizabeth
Merck Frosst Canada and Co., 16711 Trans Canada Hwy, Quebec, Kirkland, Canada.
J Pharm Biomed Anal. 2003 Jan 1;30(5):1469-77. doi: 10.1016/s0731-7085(02)00484-3.
A method was developed using solid-phase microextraction (SPME) and gas chromatography to monitor the peppermint flavor loss in a taste-masked tablet formulation. This was accomplished by headspace sampling of two major components of peppermint: menthone and menthol. It was found that the excipients from the tablet produced an important matrix effect and that standard addition analysis was necessary for improved accuracy of the determination. The method was shown to be specific and precise. Furthermore, the method produced acceptable results with adequate quantitation limits to determine peppermint flavors in taste-masked tablets. The optimized extraction procedure was successfully used to monitor the stability of peppermint flavor in an oral solid formulation. The accelerated stability studies of the tablet showed that the menthone and menthol was lost in an exponential manner and levels off after several days of heat exposure.
开发了一种使用固相微萃取（SPME）和气相色谱法来监测掩味片剂配方中薄荷香味损失的方法。这是通过对薄荷的两种主要成分：薄荷酮和薄荷醇进行顶空采样来实现的。发现片剂中的辅料产生了重要的基质效应，并且需要进行标准加入分析以提高测定的准确性。该方法具有特异性和精确性。此外，该方法产生了可接受的结果，具有足够的定量限来测定掩味片剂中的薄荷香味。优化后的萃取程序成功用于监测口服固体制剂中薄荷香味的稳定性。片剂的加速稳定性研究表明，薄荷酮和薄荷醇以指数方式损失，并在热暴露几天后趋于平稳。
