Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA 02139, USA.
Int J Pharm. 2010 May 31;391(1-2):13-20. doi: 10.1016/j.ijpharm.2010.02.009. Epub 2010 Feb 13.
The use of a light induced fluorescence (LIF) instrument to estimate the total content of fluorescent active pharmaceutical ingredient in a tablet from surface sampling was demonstrated. Different LIF sampling strategies were compared to a total tablet ultraviolet (UV) absorbance test for each tablet. Testing was completed on tablets with triamterene as the active ingredient and on tablets with caffeine as the active ingredient, each with a range of concentrations. The LIF instrument accurately estimated the active ingredient within 10% of total tablet test greater than 95% of the time. The largest error amongst all of the tablets tested was 13%. The RMSEP between the techniques was in the range of 4.4-7.9%. Theory of the error associated with the surface sampling was developed and found to accurately predict the experimental error. This theory uses one empirically determined parameter: the deviation of estimations at different locations on the tablet surface. As this empirical parameter can be found rapidly, correct use of this prediction of error may reduce the effort required for calibration and validation studies of non-destructive surface measurement techniques, and thereby rapidly determine appropriate analytical techniques for estimating content uniformity in tablets.
利用光致荧光（LIF）仪器从表面取样估算片剂中荧光活性药物成分的总量，证明了这一点。不同的 LIF 取样策略与每种片剂的总片剂紫外（UV）吸光度测试进行了比较。对含有三氨蝶呤作为活性成分的片剂和含有咖啡因作为活性成分的片剂进行了测试，每种片剂都有一系列浓度。LIF 仪器在 95%以上的时间内准确地估算了总片剂测试中大于 10%的活性成分。所有测试片剂中最大的误差为 13%。两种技术之间的 RMSEP 在 4.4-7.9%之间。与表面取样相关的误差理论得到了发展，并发现可以准确地预测实验误差。该理论使用了一个经验确定的参数：片剂表面不同位置的估计值偏差。由于可以快速找到这个经验参数，因此正确使用该误差预测可能会减少对非破坏性表面测量技术的校准和验证研究的工作量，并能快速确定估算片剂含量均匀度的适当分析技术。
