Abstract
A simple, rapid, specific, and reliable high performance liquid chromatographic assay of chlorpheniramine maleate in tablets has been developed. Reverse phase chromatography was conducted using a mobile phase of 0.05 M ammonium acetate and acetonitrile, (60%, v/v) pH 3.5 with UV detection at 265 nm. The % recovery and coefficient of variation from six placebo tablets containing 4 mg of chlorpheniramine maleate were 100.2, 98.25, and 0.4, 2.2 by the HPLC and B.P. 93 methods, respectively. Replicate regression analyses of three standard plots in the concentration range 0.5 - 20 mcg/mL obtained on three different days gave a correlation coefficient >0.9998 and a coefficient of variation of the slopes <1.54%.
The assay was precise within day and between days as indicated by ANOVA test. The average percentage recoveries from 10 replicate tablets of chlorpheniramine maleate was 101.35 and 100.464 of the label amount, and their coefficients of variation were 0.8 and 4.6 by the HPLC and B.P. 93. methods, respectively.
A comparison of the proposed HPLC and the B.P. 93. method, indicated that the HPLC method is more rapid, simple and reproducible. It is suggested that the proposed HPLC procedure could be used for routine quality control and dosage form assay of chlorpheniramine maleate.