METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIES FOR DETERMINATION OF BUMETANIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-UPLC

Chaitanya Boni; Raja Sundararajan

doi:10.22159/ijpps.2018v10i3.23728

Authors

Chaitanya Boni GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-Andhra Pradesh, India Pincode 530045
Raja Sundararajan GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-Andhra Pradesh, India Pincode 530045

DOI:

https://doi.org/10.22159/ijpps.2018v10i3.23728

Keywords:

UPLC, Bumetanide, Method development, ICH Guidelines

Abstract

Objective: The objective of the study was to develop a new, simple, accurate, precise and reproducible RP-UPLC method for the estimation of bumetanide in bulk and pharmaceutical dosage form.

Methods: Acquity SB C18, 2 x 100 mm, 1.8 Âµmm, 5m particle size column with the mobile phase consisting of water: acetonitrile in the ratio of 30:70 v/v were used. The effluents were moniRTat 254 nm and the flow rate was 1.0 ml/minute.

Results: The retention time was 0.852 min. Quantitative linearity was obeyed in the concentration range of 12.5 to 75 Î¼g/ml. The correlation coefficient for bumetanide was found to be 0.999. Recovery and assay studies of bumetanide were within 99 to 102%, indicating that the proposed method can be adaptable for quality control analysis of bumetanide. The % RSD for precision and accuracy of the method was found to be less than 2%. Bumetanide was subjected to stress environment of degradation in aqueous solutions including oxidation, hydrolysis, thermal and photolysis degradation.

Conclusion: Proposed method was found to be simple, accurate, precise, and quick and can be used for regular analysis. This condition was applied to tablet dosage form. The statistical parameters and recovery studies were reported.

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Author Biography

Chaitanya Boni, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-Andhra Pradesh, India Pincode 530045

Nil

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