Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Benidipine and Telmisartan

ABSTRACT: The primary goal of this work was to create and test a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous detection of telmisartan (TEL) and benidipine hydrochloride (BEN) in bulk and pharmaceutical dose form. Using reverse phase chromatography, the developed method is simple, appropriate, and more efficient, stable, and reproducible. The C18 column, measuring 250 x 4.6 mm and packed with 5.0 μm particles, was used to separate TEL and BEN. When used as a mobile phase, various solvent solutions were evaluated and improved. TEL (100 μg/ml) and BEN (10 μg/ml) were used for their good peak forms and resolution in Methanol: Ammonium Dihydrogen Orthophosphate Buffer, pH 3.5 (80:20 v/v). The mobile phase was flowing at 1.0 ml/min, and both analytes were detected at 237 nm using UV/ Vis detectors. The method's development and validation were based on linearity, accuracy, precision, robustness, specificity, linearity, detection limit, and quantitation limit. TEL and BEN were found to be linear at doses of 5-15 and 50-150 μg/ml. According to this study, the impact of RP-HPLC techniques included a reduction of sample quality and standardization. The fact that the percentage relative standard deviation was less than 2% proved the exceptional precision of the proposed procedure.