Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ANALYSIS OF ENALAPRIL MALEATE IN BULK AND TABLET DOSAGE FORM

Manisha S. Phoujdar*, Prachi S. Patil and Shwetal P. Vassa

ABSTRACT

A simple, accurate, sensitive, precise and economical spectroscopic method has been developed and validated for the determination of enalapril maleate in bulk and tablet dosage formulation. The solvent used is double distilled water and methanol (for solubility purpose) to determine the enalapril maleate in bulk and tablet dosage formulation. The wavelength corresponding to maximum absorbance of the enalapril maleate was found at 206.8nm. The method obeys Beer’s law in the concentration range of 5-25 μg/mL and exhibited good correlation coefficient (R2=0.999) and the regression of the curve was found y=0.036x+0.075 with excellent mean recovery (96-100 %). The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 1.27μg/mL and 3.851μg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. The values of relative standard deviation and percentage recovery were found to be satisfactory; indicating that the proposed method is precise, accurate and economical hence can be used for the routine analysis.

Keywords: Enalapril maleate, UV spectrophotometry, Validation, Assay, ICH Guidelines.