Suryanarayanan R, Herman C S
Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis 55455.
Pharm Res. 1991 Mar;8(3):393-9. doi: 10.1023/a:1015814119985.
A powder X-ray diffraction technique has been developed for the quantitative analysis of the active ingredient in intact tablets. Two model drugs were used: lithium carbonate (LC) and carbamazepine (CBZ). Mixtures containing various weight fractions of each drug and microcrystalline cellulose were compressed into tablets and the integrated intensities of several diffraction lines of each were used for quantitative purposes. The ratio of the integrated intensity of these lines in tablets, made from mixtures of drug and microcrystalline cellulose, to the intensity of the same lines in tablets made from only drug was calculated as a function of the weight fraction of the drug in the mixture. These ratios were also experimentally determined and the relative error in the determination of LC was less than 12%. CBZ tablets containing starch were also prepared. In the CBZ tablets containing microcrystalline cellulose or starch, the relative error in the determination of CBZ was less than 10% only when the weight fraction of CBZ in the tablets was greater than or equal to 0.4.
已开发出一种粉末X射线衍射技术，用于完整片剂中活性成分的定量分析。使用了两种模型药物：碳酸锂（LC）和卡马西平（CBZ）。将含有每种药物和微晶纤维素不同重量分数的混合物压制成片剂，并将每种药物几条衍射线的积分强度用于定量目的。由药物和微晶纤维素混合物制成的片剂中这些线条的积分强度与仅由药物制成的片剂中相同线条的强度之比，作为混合物中药物重量分数的函数进行计算。这些比率也通过实验确定，LC测定中的相对误差小于12%。还制备了含有淀粉的CBZ片剂。在含有微晶纤维素或淀粉的CBZ片剂中，仅当片剂中CBZ的重量分数大于或等于0.4时，CBZ测定中的相对误差才小于10%。
