Method Development and Validation For The Quantification Of Pantoprazole By RP-HPLC And Spectrophotometry In Pharmaceutical Oral Dosage Form

Abstract

Simple, Precise, rapid and accurate methods were developed for the estimation of Pantoprazole in bulk and in dosage form. The methods are UV Spectroscopic method, Visible Spectroscopic method & RP-HPLC method. The λmax of of PNP was found to be 290nm in methanol. The bulk drug PNP obeyed Beer’s law at 5-30µg / ml. The correlation coefficient was found to be 1 for both the drugs. The dosage form of the drugs was quantified by the following three methods. Method A involves standard absorbance method. The RSD proves there producibility of the method and thus the precision of the developed method. Method B involves determination of AUC for both standard and sample spectra obtained in Method A between two selected wavelength. The correlation coefficient was found to be 0.9990 for PNP. The recovery percentage was found to be 98 to102% which proves no interference by the sample matrix. Method C involves the derivatisation of the zero order spectra to second order spectra.  The recovery spectra were also derivatized and used. All the methods have shown good linearity, precision and accuracy. The low % RSD values in recovery studies for all the above methods indicate that there is no interference due to excipients used in the formulations. Hence it is concluded that the developed UV – Visible and RP-HPLC methods were found to be simple, precise, accurate and rapid methods for the analysis of Pantoprazole in its pure form and in its pharmaceutical dosage formulation. Thus, all the above adopted methods can be effectively used for the routine analysis of Pantoprazole in pharmaceutical dosage form.