A modified high-performance liquid chromatographic method for the analysis of pantoprazole sodium in pharmaceutical dosage forms using lansoprazole as internal standard

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 × 4.6 mm i.d., 5 μm particle size) using the photodiode array detector at 280 nm. The optimized mobile phase was consisted of a mixture of 0.1 M ammonium acetate solution and methanol (42:58, v/v), pumped at a flow rate 1.0 mL min−1. The retention times for pantoprazole and lansoprazole were 8.10 and 11.15 min, respectively. Linearity range was 3.06–1243.0 μg mL−1 with limit of detection value of 0.78 μg mL−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.

Keywords

• Pantoprazole sodium
• Liquid chromatography
• Pharmaceutical dosage form