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Inventi Impact: Biomedical Analysis
publication date: 2012/10/15

DEVELOPMENT AND VALIDATION OF DRONEDARONE HCL IN PLASMA BY RP-HPLC METHOD COUPLED WITH UV-DETECTOR
                  Disha Patel*, Avijit Choudhury

ABSTRACT
A new and rapid method has been developed and validated for quantification of Dronedarone HCl in plasma using reverse phase high performance liquid chromatography combined with UV-detection. Sample preparation includes the simple protein precipitation. Chromatographic separation was performed on Luna C18, X-bridge waters column (250×4.6 mm, 5μm) by using isocratic mobile phase containing Buffer(pH 4.9):methnol:acetonitrile (30/30/40)(Buffer containing glacial acetic acid and pH adjusted with ammonia) at the flow rate of 1ml/min at 240nm. Retention time was found 5.8 min. The different analytical performance parameters such as system suitability, specificity and selectivity, linearity range, recovery, precision, limit of detection (LOD) and limit of quantification (LOQ) were determined. The calibration curves were linear (r2=0.999) over the concentration range 300-700 ng/ml for Dronedarone HCl and 300-700 ng/ml for Dronedarone HCl in plasma (r2= 0.999). Average % recovery was found to be 87.69%. The LOD and LOQ for Dronedarone were 42.17 ng/ml and 127.78 ng/ml, respectively. The lower limit of quantification for bioanalytical method of Dronedarone HCl was 133.87ng/ml. The proposed methods are highly sensitive, precise and accurate and hence were successfully applied for the reliable quantification of Dronedarone HCl in plasma.

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How to Cite This Article

Disha Patel*, Avijit Choudhury,  " DEVELOPMENT AND VALIDATION OF DRONEDARONE HCL IN PLASMA BY RP-HPLC METHOD COUPLED WITH UV-DETECTOR ",  Inventi Impact: Biomedical Analysis ,  Vol. 2012 , Article ID- " Inventi:pba/47/12 " 2012  [ cited 2014 Jul 23 ]  Available From  


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