Development and Validation of UV and RP-HPLC Methods for Simultaneous Estimation of Mirabegron and Solifenacin Succinate in Their Pharmaceutical Dosage Form

Abstract

Recently, a new formulation containing Mirabegron (MB) and Solifenacin succinate (SFS) has been approved for the management of over active bladder. However, only one analytical method has been reported for the simultaneous determination of both the analytes. Therefore, the current study was design to develop simple UV derivative spectroscopic and rapid RP-HPLC methods for simultaneous determination of MB and SFS. The chromatographic separation of MB and SFS was performed using Phenomenex Kinetex C₁₈ (150mm × 4.5 mm × 5 µm) analytical column. A mixture of Water: Acetonitrile (20:80%v/v) was consider as mobile phase, at a flow rate of 1ml/min and at detector wavelength 225nm. A linear response was observe over the concentration range 2.5-12.5 µg/ml and 0.5-2.5 µg/ml respectively. The first order derivative method was develop by derivatisation of the zero absorption spectra for the first absorption spectra. The Zero crossing point of MB and SFS at 221 nm and 266 nm was obtain respectively. Beer’s law is obey in the concentration range of 7.5-20 µg/ml and 1.5-4 µg/ml for MB and SFS with correlation coefficient (R2) of 0.9984 and 0.9993 respectively. Both the methods were validated in accordance to guidelines for linearity, precision, repeatability, limit of detection (LOD), Limit of Quantification (LOQ), accuracy and robustness. Further, both the methods were validated and compared statistically using Student’s-t-test and employed for the concurrent estimation of MB and SFS in formulations. The proposed methods were simple, accurate, precise, and rapid. Therefore, they can be use for regular quality control of MB and SFS formulations and dissolution studies as well.