Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AZELNIDIPINE AND METOPROLOL SUCCINATE FROM THE SYNTHETIC MIXTURE BY THREE DIFFERENT UV SPECTROPHOTOMETRIC METHODS

Dhruvin M. Prajapati*, Apexa Kadam and Dr. Rajashree Mashru

Abstract

Three new UV spectrophotometric methods namely simultaneous equation, Q-absorbance ratio, and first derivative (zero-crossing) spectroscopic methods were developed and validated for simultaneous estimation of Azelnidipine and Metoprolol Succinate in tablet formulation which was simple, sensitive, precise and accurate. In the simultaneous equation method, absorbance was measured at 223 and 257 nm for both drugs. Azelnidipine and Metoprolol Succinate showed an iso-absorptive point at 233 nm in the Q- absorbance ratio method. The second wavelength used was 257 nm which is λ max of Azelnidipine in Methanol: Water (80:20) solvent. The first derivative (zero-crossing) method was based on the transformation of UV spectra into first derivative spectra followed by measurement of the first derivative signal at 241 and 234 nm for Azelnidipine and Metoprolol Succinate, respectively using 2 nm as wavelength interval (Δλ) and 1 as scaling factor. Developed methods were validated according to ICH guidelines including parameters viz., specificity, linearity and range, precision, accuracy, the limit of detection, and quantification. All three methods showed a linear response in the concentration range of 1-5 μg/ml and 6.25-31.25 μg/ml for Azelnidipine and Metoprolol succinate respectively. Results of method validation parameters follow ICH guidelines is in acceptable limits. Based on the assay results obtained, methods were compared using one-way ANOVA. The outcome of the statistical analysis proved that there was no considerable dissimilarity between all the developed methods. Methods were found to be simple, fast, highly sensitive, cost-effective, and hence can be useful for simultaneous estimation of Azelnidipine and Metoprolol Succinate which showed good applicability of the developed method.

Keywords: Azelnidipine (AZE), Metoprolol Succinate (MET), simultaneous equation, Q-absorbance ratio, first derivative (zero-crossing) spectroscopic methods.