Assessment of Aliskiren Hemifumarate and Amlodipine Besylate in combined Tablet Dosage form by Three Simple UV Spectrophotometric Methods

Background: For a cardiovascular patient's blood pressure to be effectively controlled, more than one drug is required. When coupled with amlodipine besylate (AMLO), a calcium channel blocker, Aliskiren hemifumarate (ALI) is the 1st nonpeptide, low molecular mass, orally active transition state rennin inhibitor to efficaciously normalize blood pressure and cardiac ailments.

Objective: Three innovative, easy, sensitive, exact, and accurate UV spectrophotometric approaches, including simultaneous equation method (SEM), absorbance ratio method (ARM) and 1st derivative (zero-crossing) spectroscopic approach (FDR), were created and authenticated by validation for synchronized estimation of ALI and AMLO in tablet formulation.

Materials and Methods: The SEM was used to measure the absorbance of both medicines at 237 and 280 nm. ALI and AMLO were calculated using 237 and 271 nm, respectively, in the ARM. ALI and AMLO, on the other hand, used the FDR technique to transform UV spectra to first derivative spectra, with the first derivative signal captured at 237 and 254 nm, respectively. The wavelength interval (Δλ) was kept at 2 and the scaling factor was kept at 1 when transforming zero-order spectra using the first derivative approach. Validation of the proposed processes was done in compliance with the “International Conference on Harmonization” (ICH) recommendations.

Results: SEM and ARM both showed a linear outcome in the range of 1-50 µg/ml for ALI and AMLO. FDR, on the other hand, was shown to be more sensitive and linear between 0.5 and 50 µg/ml for both medications. The results of the method validation parameters were within the allowed ranges of the ICH guidelines.

Conclusion: The proposed procedures were shown to be relatively quick, sensitive, simple, and cost-effective, and can thus be used for scheduled quality control analysis of ALI and AMLO in the mixed tablet.