Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF MIRABEGRON IN NOVEL DRUG DELIVERY SYSTEM

Abhijeet Arjun Chaudhari*, Jagdish Chaudhari, Vijay Munipalli, Raman Singh, Smita Nayak and Bhaskar Vaidhun

ABSTRACT

Backgrounds: In this study, a simple, rapid, accurate, sensitive and reproducible RP-HPLC method for determination of mirabegron from prolonged-release tablets was developed using methylparaben as internal standard has been described. The different analytical performance validation parameters such as linearity, accuracy, specificity, precision and robustness were determined according to International Conference of Harmonization ICH Q2 (R1) guidelines and found to be within limits. Materials and Methods: Successful separation was achieved by isocratic elution on a Thermo BDS Hypersil C18 column (250mm X 4.6mm, i.d., 5μm,). The mobile phase was composed of buffer pH: 2.0 sodium perchlorate and acetonitrile (70:30 v/v) at the flow rate of 1 mL/min using UV detection at 254 nm, column oven temperature 40ºC and injection volume 10 μL. Results: The retention time for mirabegron was found to be 4.830 min. The absorption was found to be linear in the concentration range of 5 to 30 μg/mL. Recovery studies were carried out and % RSD for reproducibility was found to be below 2%. The method was sufficiently robust for normally expected variations in chromatographic conditions. Conclusion: The developed RP-HPLC method for the determination of mirabegron is simple, rapid, accurate, precise and reproducible. The developed method was validated based on ICH guidelines.

Keywords: .