Validated Stability Indicating RP-HPLC Method for the Quantification of Process Related Impurities of Solifenacin and Mirabegron in Pharmaceutical Formulations

Abstract

To assess solifenacin (SOL) and mirabegron (MER) simultaneously, a verified reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed to indicate stability. The method was thoroughly evaluated and found to meet satisfactory criteria for precision, linearity, accuracy, limits on detection, and robustness, limits on quantitation. The quantitation wavelength of 231 nm was determined. Linearity was successfully demonstrated across concentration ranges of 5 to 25 μg/mL of solifenacin and 50 to 250 μg/mL of mirabegron. RPHPLC separations was conducted employing a Phenomenex L. C18 column measuring 250 x 4.6 mm and containing particles as small as 5 μm. The methanol and phosphate buffer (pH 7) were combined in a volumetric ratio of 25:75 to create the mobile phase. The separation is accomplished at a 0.7 mL per minute flow rate. Time spent in retention for mirabegron and solifenacin had been established at 5.521 and 9.161 minutes, respectively. Forced degradation studies validated the stability-indicating character of the approach, which included hydrolysis under acidic and basic conditions, exposure to H2O2, thermal degradation, and photodegradation. Mirabegron and solifenacin exhibited 10 to 20% degradation under the specified conditions. Importantly, the process evaluated the two prescription drugs in detail with all degradation products generated during the forced degradation experiments. This developed method is characterized as straightforward, specific, and cost-effective, making them suitable of the simultaneous estimate of mirabegron with solifenacin in tabs dose forms.