DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF AZELNIDIPINE IN BULK AND TABLET DOSAGE FORM

Sahana K. M.*, Naveen Kumar G. S. and Suresh D. N.

ABSTRACT

Simple, precise and accurate area under curve spectroscopic method has been developed and validated for the estimation of Azelnidipine in bulk and pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 254nm in acetonitrile solution and Area under Curve [AUC] in absorption spectra were measured between the wavelength range 249 to 259nm which obeys Beer’s law in the concentration range of 2-12μg/ml. The linearity study carried and regression coefficient was found to be 0.9993 and it has showed good linearity, precision during this concentration range. The % recovery was found to be 98.6-101.9. The LOD and LOQ were found to be 0.04 and 0.13μg/ml. The % relative standard deviation were found less than 2. According to ICH guidelines the method has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for reliable quantification of Azelnidipine in bulk form and pharmaceutical dosage form.

Keywords: Azelnidipine, Area under curve spectroscopy, Validation, Pharmaceutical formulations.