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Vol. 31 No. 10 (2019): Vol 31 Issue 10

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RP-HPLC Estimation of Bumetanide and its Impurities in Oral Solid Dosage Form

https://doi.org/10.14233/ajchem.2019.22069
P. Suresh Kumar
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Vaddeswaram-522502, India
G.V. Krishna Mohan
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Vaddeswaram-522502, India
A. Naga Babu
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Vaddeswaram-522502, India

Corresponding Author(s) : G.V. Krishna Mohan

drkrishnamohangv@kluniversity.in

Asian Journal of Chemistry, Vol. 31 No. 10 (2019): Vol 31 Issue 10

Abstract

A novel and simultaneous stability indicating RP-HPLC method has been developed for quantitative analysis of bumetanide in fixed dose pharmaceutical formulations. Bumetanide and its degradation products are well separated by the Discovery C18, 250 × 4.6 mm, 5 μm column as a stationary phase and (50:50 v/v) of 0.1 % o-phthalaldehyde and acetonitrile as a mobile phase. All the compounds are monitored using photodiode array detector at 254 nm with an isocratic method and the flow rate of 1.0 mL/min was maintained. Validation of method was performed as per International Council for Harmonization (ICH) guidelines and the parameters namely; precision, accuracy, specificity, stability, robustness, linearity, limit of quantitation (LOQ) and limit of detection (LOD) were evaluated. The linearity of the proposed method was found to be 0.315-1.875 μg/mL for bumetanide and its impurities. The developed method is more economical and suitable for laboratory use because of solvent consumption is very less. Hence, the developed method can be used for the determination of bumetanide and its impurities in drug product stability studies and pharmaceutical formulations.

Keywords

RP-HPLC Bumetanide Degradation products
Kumar, P. S., Krishna Mohan, G., & Babu, A. N. (2019). RP-HPLC Estimation of Bumetanide and its Impurities in Oral Solid Dosage Form. Asian Journal of Chemistry, 31(10), 2215–2221. https://doi.org/10.14233/ajchem.2019.22069
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