Sensitive and validated spectrophotometric methods for the determination of pantoprazole sodium in pharmaceuticals using N-bromosuccinimide based on redox and complexation reactions

Abstract

Two simple, sensitive and rapid methods are described for the determination pantoprazole sodium sesqui hydrate (PNT) in bulk drug and in formulations using N-bromosuccinimide (NBS) as the oxidimetric reagent. The methods involve the addition of a known excess of NBS to PNT in HCl medium followed by estimation of the unreacted oxidant by two reaction schemes involving the use of iron(II) and thiocyanate (method A) or tiron (method B). In both methods, the absorbance is found to decrease linearly with PNT concentration. Beer’s law is obeyed over the ranges 0.25-3.5 and 1-15 µg mL^-1 for method A and method B, respectively. The calculated molar absorptivity values are 1.4 × 10⁵ and 2.5 × 10⁴ L mol^-1cm^-1 for method A and method B, respectively. The limit of detection (LOD) and quantification (LOQ) are also reported for both methods. The RSD values for intra-day and inter-day precision studies were less than 2.5 and 3.0 %, respectively. Both the methods were applied to the determination of PNT in dosage forms and the results were satisfactory, and were comparable with those obtained by the reference method. The accuracy and reliability of the proposed methods were further ascertained by recoveries studies, and the recoveries of the spiked drug ranged between 98.5 and 102.5 %.

KEY WORDS: Pantoprazole sodium, Determination, N-bromosuccinimide, Complexation reactions, Pharmaceuticals

Bull. Chem. Soc. Ethiop. 2008, 22(1), 135-141.