Drug testing and analysis

Spectrophotometric determination of peptic ulcer sulfur-containing drugs in bulk form and in tablets.

PMID 20878884


Two spectrophotometric procedures are suggested for the determination of three irreversible proton pump inhibitors, rabeprazole (RAB), omeprazole (OMP) and pantoprazole (PAN) in pure form and in different pharmaceutical formulations. The first method is based on the oxidation of RAB and PAN with potassium iodate in an acidic medium followed by extracting the liberated iodine with cyclohexane and measurement at λ = 520 nm. Beer's law is valid in the concentration ranges from 10-400 and 5-400 µg ml(-1) for RAB and PAN, respectively. The apparent molar absorptivities of the resulting coloured product were found to be 1.34 × 10(3) and 1.64 × 10(3) l.mol(-1). cm(-1) for RAB and PAN, respectively. The second method is based on the interaction of the basic drugs, OMP, RAB and PAN, in 1,2-dichloroethane with bromophenol blue (BPB), bromocresol green (BCG) and bromocresol purple (BCP) in the same solvent to produce stable coloured ion pairs with maximum absorbance at 385-405 nm. Regression analysis of Beer's plots showed good correlation in the concentration ranges 10-60, 10-60 and 5-40 µg ml(-1) for OMP, 10-150, 10-150 and 10-60 µg ml(-1) for RAB and 10-250, 10-150 and 10-100 µg ml(-1) for PAN with BPB, BCG and BCP reagents, respectively. The limits of detection are 0.46-7.69 µg ml(-1) and limits of quantitation range between 1.52-8.53 µg ml(-1). The optimum assay conditions were investigated and the recovery of the drugs from their dosage forms ranged from 99.33% to 100.5%. Intraday relative standard deviations (RSD) were 0.029-1.397% and the correlation coefficients ranged from 0.9992 to 1. The two methods can be applied successfully for the determination of these drugs in tablets. The results of analysis were validated statistically through recovery studies.