Abstract
A simple, accurate and sensitive spectrophotometric method for determination of H-2-receptor antagonists: cimetidine (CIM), famotidine (FAM), nizatidine (NIZ), and ranitidine hydrochloride (RAN) has been fully developed and validated. The method was based on the reaction of these drugs with NBS and subsequent measurement of the excess N-bromosuccinimide by its reaction with p-aminophenol to give a violet colored product (lambda(max) at 552 nm). Decrease in the absorption intensity (Delta A) of the colored product, due to the presence of the drug, was correlated with its concentration in the sample solution. Different variables affecting the reaction were carefully studied and optimized. Under optimal conditions, linear relationships with good correlation coefficients (0.9988-0.9998) were found between Delta A values and the corresponding concentrations of the drugs in a concentration range of 8-30, 6-22, 6-25, and 4-20 mu g mL(-1) for CIM, FAM, NIZ, and RAN, respectively. Limits of detection were 1.22, 1.01, 1.08, and 0.74 mu g mL(-1) for CIM, FAM, NIZ, and RAN, respectively. The method was validated in terms of accuracy, precision, ruggedness, and robustness; the results were satisfactory. The proposed method was successfully applied to the analysis of the above mentioned drugs in bulk substance and in pharmaceutical dosage forms; percent recoveries ranged from 98.5 +/- 0.9 to 102.4 +/- 0.8% without interference from the common excipients. The results obtained by the proposed method were comparable with those obtained by the official methods.