Abstract
A simple, rapid and reliable high performance liquid chromatographic procedure for the quantitation of phenylbutazone in pharmaceutical dosage forms was developed, and compared with the U. S. P. XXI method and a spectrophotometric assay developed in this laboratory. A comparison of the three methods indicated that the HPLC method is the most rapid, simple and reproducible. The recoveries based on six placebo samples were 100.2, 99.2, and 99.4% by HPLC, UV and the U. S. P. method, respectively, and their respective CVs were 0.39, 0.73, and 1.5%. Replicate regression analyses of three standard plots in the concentration range of 0.02-0.12 mg/ml obtained using the HPLC assay on three different days yielded a correlation coefficient <0.999 and the coefficient of variation for the three slopes was 1.05%. It is suggested that the proposed HPLC method should be used for routine quality control and dosage form assay of phenylbutazone.