Quantitative Analysis of Pantoprazole Sodium Sesquihydrate in Bulk and Solid Dosage Form via UV-Spectrophotometric Method

Abstract:

Pantoprazole sodium sesquihydrate, is a proton pump inhibitor, was analyzed by using UV spectrophotometry. The quantification of pantoprazole sodium sesquihydrate in distilled water was performed in the wavelength range of 290 nm at 20 μgmL^-1. The linearity range is 5-35 μgmL^-1 by using UV spectrophotometry. The developed method was applied directly and easily to the analysis of the pantoprazole sodium sesquihydrate in bulk and pharmaceutical tablet preparations. The developed method was completely validated according to ICH guidelines. The accuracy of the developed method was calculated in terms of percentage recovery (99.20-101.21%) and %RSD values less than 1% were found in precision. The LOD and LOQ were 0.989 and 1.954 μgmL^-1, respectively. Because of simplicity, accuracy and cost-effectiveness, this validated method is helpful for a daily laboratory analysis of pantoprazole sodium sesquihydrate.

Key words: Pantoprazole sodium sesquihydrate, Proton pump inhibitor, UVSpectrophotometer, Method development, ICH guidelines.