Determination of a novel bile acid sequestrant in rodent diet by near-infrared spectroscopy

DMP 504 is a high molecular weight polymer currently under development by T he DuPont Merck Pharmaceutical Company as a novel bile acid sequestrant to lower serum cholesterol. To assess its safety, DMP 504 is incorporated into rodent diet for oral administration to rats and mice. An analytical method was developed to determine the accuracy and homogeneity of the blends. Sin ce a physical separation or extraction of DMP 504 from the diet was not fea sible, near-infrared spectroscopy (near-IR) was employed. The near-IR metho d provides accurate and precise results for blends containing 1.5-8.0% of D MP 504. Comparison of results at the 1.5% level with a cholate binding refe ree method is also presented. Both methods provided equivalent results for the 1.5% level. (C) 1999 Elsevier Science B.V. All rights reserved.