Abstract

VALIDATION AND DEVELOPMENT OF NEW SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF AZELNIDIPINE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

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

.

Abstract

A simple, precise, and accurate zero-order derivative spectroscopic approach has been developed and validated for the estimating Azelnidipine in bulk and pharmaceutical dosage forms. The medication has a maximum absorption (λ max) at 254nm in acetonitrile solution and obeys Beer's law in the concentration range of 2-12μg/ml. The linearity parameter was carried out, and the regression coefficient was found to be 0.9986 and it has showed good linearity and precision within this concentration range. The percent recovery was found to be 98.59-100.8, these results are within the limit and it shows method followed was accurate. The limit of detection and limit of quantification were found to be 0.050 and 0.151μg/ml, respectively. The percentage relative standard deviation was found to be less than 2. According to ICH guidelines the technique has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD, and LOQ. The developed and validated method can be successfully applied for routine quantification of Azelnidipine in bulk and pharmaceutical dosage form.

Keywords: Azelnidipine, Zero order derivative spectroscopy, Validation, Pharmaceutical formulation.