DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR SIMULTANEOUS ESTIMATION OF ILAPRAZOLE AND DOMPERIDONE IN BULK AND SOLID DOSAGE FORM BY UV-SPECTROSCOPY

Abstract

A Simple, rapid, precise and accurate stability indicating UV-Spectrophotometric method was developed for simultaneous estimation of Ilaprazole (ILA) and Domperidone (DOM) in bulk and capsule formulation and validated as per ICH guidelines. The solvent used for this method was methanol. The $\lambda$max of ILA and DOM were found to be 306 and 288 nm respectively. The linearity for ILA and DOM was in the range of 1-6 $\mu$g/ml and 3-18 $\mu$g/ml, respectively with regression coefficient(r²) of 0.999 for both drugs. The % recovery was found to be in the range of 99.29-100.87% and 99.92- 100.16% for ILA and DOM respectively. Percentage RSD for precision and accuracy of the method was found to be less than 2% .LOD values for ILA and DOM were found to be 0.0866 $\mu$g/ml and 0.4026 $\mu$g/ml respectively. LOQ values for ILA and DOM were found to be 0.2625 $\mu$g/ml and
1.241 $\mu$g/ml respectively. The Forced degradation study is validated as per ICH guidelines. The developed method is suitable for the analysis of tablet formulation for quality control purposes.