QUANTITATIVE ANALYSIS OF MIRABEGRON ER TABLETS: A COMPREHENSIVE RP-HPLC METHOD AND VALIDATION FOR THE IMPURITY DETERMINATION

This research aimed to design as well as evaluate reverse-phase high-performance liquid chromatography (RPHPLC) process to precise quantification for potential impurities in Mirabegron (MIRA) ER Tablets. The developed method utilized an Inertsil C8 - 3, 150 x 4.6 mm, 3µm column with a gradient elution program utilizing Buffer and Acetonitrile as mobile phases. The chromatographic separation achieved on a C8 stationary phase demonstrated robustness and reproducibility, with detection at a wavelength of 240 nm and a constant column temperature of 40°C. The research study was focused on MIRA and four impurities (MIR-1, Deshydroxy, Diamide-1, and Diamide2). The method exhibited specificity, precision, linearity, accuracy, robustness, ruggedness, and stability indicating characteristics. Correlation coefficients exceeding 0.997 for MIRA and its foreign substances showcased the accuracy and sensitivity of the method. Low detection and quantization limits (ranging from 0.06ppm to 0.20ppm) highlighted its high sensitivity. Accuracy is finalized by rates of recovery as 96.1% to 100.3% for all foreign substances. The stability-indicating is validated by forced degradation studies, meeting peak purity circumstances also achieving mass balance. Robustness studies further established the method's reliability, demonstrating resilience to minor chromatographic variations. This proposed RP-HPLC method accommodates a dependable, reproducible, highly accurate, and more sensitive means to quantifying MIRA-related substances in MIRA ER Tablets, making it a valuable tool for pharmaceutical quality control.