Ballbach R L, Brown D J, Walters S M
J Pharm Sci. 1977 Nov;66(11):1553-6. doi: 10.1002/jps.2600661113.
Methods for the determination of diphenoxylate hydrochloride and atropine sulfate combinations in solutions and powdered tablet composites are presented. A semiautomated assay for diphenoxylate hydrochloride in individual tablets (content uniformity) also is presented. The USP XIX assays for these products are cumbersome and, in the case of solutions, inaccurate due to spectral interferences; the proposed methods offer substantial improvements in sensitivity, specificity, and speed. Results obtained by the USP and proposed methods are compared for several lots of commercial products. The accuracy and precision of the proposed methods are shown by standard recovery studies.
本文介绍了测定溶液和片剂复合制剂中盐酸地芬诺酯和硫酸阿托品组合的方法。还介绍了一种用于单个片剂中盐酸地芬诺酯的半自动分析方法（含量均匀度）。美国药典第十九版中对这些产品的分析方法繁琐，对于溶液来说，由于光谱干扰而不准确；所提出的方法在灵敏度、特异性和速度方面有显著提高。将美国药典方法和所提出的方法对多个商业产品批次的测定结果进行了比较。标准回收率研究表明了所提出方法的准确性和精密度。
