Development and Validation of a UV Spectroscopy Absorption Ratio Method for Simultaneous Estimation of Nitrendipine and Hydrochlorothiazide

Abstract

A novel UV-spectroscopic method, characterized by its novelty, simplicity, accuracy, precision, linearity, and sensitivity, has been successfully developed and validated for the simultaneous estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form. The method relied on the absorption factor approach, employing the analysis of isosbestic points within the zero-order absorption spectra. Specifically, the isoabsorptive points at a wavelength of 282 nm were employed for the determination of Nitrendipine and Hydrochlorothiazide. The absorbance corresponding to each compound at the isoabsorptive point of 282 nm was calculated using the absorbance factor, derived as the average absorbance of various concentrations of pure Nitrendipine utilizing the isoabsorptive point at 282 nm. Subsequently, the developed method underwent a comprehensive validation process, adhering to the guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The linearity range was determined based on their respective λ max at the isoabsorptive point of 282 nm. The culmination of these results leads to the conclusion that the present research is characterized by novelty, accuracy, efficiency, precision, rapidity, reproducibility, simplicity, and sensitivity. Consequently, the proposed method is deemed suitable for the successful estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form.