DETERMINATION AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF MIRABEGRON IN TABLET DOSAGE FORM
Keywords:Reverse phase high-performance liquid chromatography, Mirabegron, Potassium dihydrogen phosphate, Acetone, UV detector
Objective: A reversed phase liquid chromatography was determined and validated for the estimation of Mirabegron in tablet dosage form.
Methods: The validation study of RP-HPLC showed a simple, rapid, accurate, precise, reproducible results by using a stationary phase: Waters Acquity HSS T-3 C18 (100 Ã— 2.1 mm, 1.7Î¼m and Mobile Phase-Potassium di-hydrogen phosphate: acetone in the ratio (40:60 v/v) at PH6.0Â±0.02. Detection is carried out at 243 nm using UV detector.
Results: The total chromatographic analysis time per sample was about 6 min with Mirabegron eluting at a retention time of 2.754. Tailing factor obtained from the standard injection is 1.6. Theoretical Plates obtained from the standard injection is 2736.7. The flow rate is 1 ml/min and linearity in the concentration range of 30-70Î¼g/ml (R2=0.999). The precision was 0.4% the intermediate precision was 0.08%. The deliberately varied chromatographic conditions in the concentration range for the evaluation of robustness is 10-50 Âµg/ml, (n=3). The limit of detection (LOD) and limit of quantitation (LOQ) for Mirabegron were 0.01Âµg/ml and 0.05Âµg/ml respectively. The % recovery is 99.8 % with % R. SD of 0.09. The results proved that the optimized HPLC method fulfills these requirements within the ICH accepted limits.
Conclusion: The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of Mirabegron in tablet dosage form.
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