UV METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AZELNIDIPINE AND OLMISARTAN IN FIXED DOSE COMBINATION
Gulam Farid Ansari, Pushpendra Kumar Soni, Rajeev Kumar Malviya
ABSTRACT
A simple, rapid, and reliable UV spectrophotometric method was developed and validated for the simultaneous estimation of Azelnidipine (ALD) and Olmesartan (OST) in fixed dose combination tablet dosage form. The method was based on the simultaneous equation approach using two selected wavelengths. The maximum absorption (?max) of Azelnidipine and Olmesartan were found to be 264 nm and 282 nm respectively. The linearity of the method was established in the concentration range of 5–25 µg/ml for both drugs with correlation coefficients of 0.9999 for ALD and 0.9993 for OST, indicating excellent linearity. The developed method was validated according to analytical validation guidelines and parameters such as accuracy, precision, repeatability, intermediate precision, and reproducibility were evaluated. The percentage recovery values ranged from 98.31% to 98.78% for ALD and 98.33% to 98.94% for OST, demonstrating the accuracy of the method. Precision studies showed %RSD values less than 2%, confirming the reliability and reproducibility of the method. The developed method was successfully applied for the analysis of marketed tablet formulations and the percentage assay results were found to be within acceptable limits. Therefore, the proposed UV spectrophotometric method is simple, precise, accurate, and suitable for routine quality control analysis of Azelnidipine and Olmesartan in combined pharmaceutical dosage forms.
[Full Text Article]