Abstract
A Simple and rapid reversed-phase high-performance liquid chromatographic method for the direct determination of pantoprazole in pharmaceutical dosage forms was developed and validated. Lansoprazole was used as internal standard. The chromatographic separation of pantoprazole and lansoprazole was achieved on a Nucleodur C8 column (250×4.6mm i.d., 5μm particle size) using the photodiode array detector at 280nm. The optimized mobile phase was consisted of a mixture of 0.1M ammonium acetate solution and methanol (42:58, v/v), pumped at a flow rate 1.0mLmin−1. The retention times for pantoprazole and lansoprazole were 8.10 and 11.15min, respectively. Linearity range was 3.06–1243.0μgmL−1 with limit of detection value of 0.78μgmL−1. The precision of the method was demonstrated using intra- and inter-day assay RSD% values which were less than 2.07%, while the recovery was 99.07–103.95%. No interference from any components of pharmaceutical dosage forms or degradation products was observed. According to the validation results, the proposed method was found to be specific, accurate, precise and could be applied to the quantitative analysis of pantoprazole in tablets.
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