DETERMINATION AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF MIRABEGRON IN TABLET DOSAGE FORM


B. Mounika, L. Srikanth, A. Venkatesha

Abstract


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 × 2.1 mm, 1.7μm and Mobile Phase-Potassium di-hydrogen phosphate: acetone in the ratio (40:60 v/v) at PH6.0±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 30-70μg/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 µg/ml, (n=3). The limit of detection (LOD) and limit of quantitation (LOQ) for Mirabegron were 0.01µg/ml and 0.05µg/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.

 


Keywords


Reverse phase high-performance liquid chromatography, Mirabegron, Potassium dihydrogen phosphate, Acetone, UV detector

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About this article

Title

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

DOI

10.22159/ijcpr.2017v9i5.22158

Date

21-09-2017

Additional Links

Manuscript Submission

Journal

International Journal of Current Pharmaceutical Research
Vol 9, Issue 5 (Aug-Sep), 2017 Page: 140-151

Online ISSN

0975-7066

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Authors & Affiliations

B. Mounika
SVS Group of Institutions, School of Pharmacy, Hanamkonda Warangal, Telangana 506015
India

L. Srikanth
SVS Group of Institutions, School of Pharmacy, Hanamkonda Warangal, Telangana 506015
India

A. Venkatesha
SVS Group of Institutions, School of Pharmacy, Hanamkonda Warangal, Telangana 506015
India


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