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Journal of pharmaceutical and biomedical analysis

Journal of pharmaceutical and biomedical analysis

IF: 3.1
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RP-HPLC method for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in tablet formulation

Published:8 July 2010 DOI: 10.1016/j.jpba.2009.10.021 PMID: 19926421
Sneha J. Joshi , Pradnya A. Karbhari , Suvarna I. Bhoir , K.S. Bindu , Chhanda Das

Abstract

A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of bisoprolol fumarate and hydrochlorothiazide in pharmaceutical dosage form. The method involves the use of easily available inexpensive laboratory reagents. The separation was achieved on an Inertsil ODS 3V (25?cm?×?4.6?mm) 5?μm column with isocratic flow. The mobile phase at a flow rate of 1.0?mL?min?1, consisted of 0.1?M potassium dihydrogen phosphate buffer and acetonitrile (70:30, v/v). The UV detection was carried out at 228?nm. A linear response was observed over the concentration range 2.5–50?μg?mL?1 of bisoprolol fumarate and the concentration range 6.25–125?μg?mL?1 of hydrochlorothiazide. Limit of detection and limit of quantitation for bisoprolol fumarate were 0.01 and 0.03?μg?mL?1, respectively and for hydrochlorothiazide were 0.01 and 0.05?μg?mL?1, respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, robustness, ruggedness and system suitability. Individual drugs (bisoprolol fumarate and hydrochlorothiazide), their combinations and the tablets were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions. The resultant stressed samples were analyzed by the proposed method. The method gave high resolution among the degradation products and the analytes. The peak purity of analyte peaks in the stressed samples was confirmed by photodiode array detector. The method was used for accelerated stability study on marketed and in-house formulations. The analysis concluded that the method was selective for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide and was stability-indicating.

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Related products
Procduct Name CAS Molecular Formula Supplier Price
Acetonitrile 75-05-8 C2H3N 1022 suppliers $61180.00
Potassium Phosphate Monobasic 7778-77-0 H2KO4P 934 suppliers $9.00-$7640.00
Hydrochlorothiazide 58-93-5 C7H8ClN3O4S2 594 suppliers $14.00-$1950.00
Bisoprolol fumarate 104344-23-2 C22H35NO8 581 suppliers $28.00-$925.00
BISOPROLOL FUMARATE 105878-43-1 C22H35NO8 4 suppliers $25.00-$113.00
BISOPROLOL FUMARATE 66722-45-0 C22H35NO5 4 suppliers Inquiry

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