Development and validation of new RP-HPLC method for simultaneous estimation of drug Duloxetine and Mecobalamin in tablet dosage form
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2016, Vol 4, Issue 4
Abstract
A simple, economic, accurate and precise reverse phase high performance liquid chromatography method for analysis of Duloxetine and Mecobalamin was developed and validated according to ICH guidelines. The quantification of the drug was carried out using PDA (photodiode array) detector. Column in isocratic mode, with mobile phase Methanol:Water in ratio of 80:20 was used. The flow rate was 1.0 ml/min and effluent was monitored at 210nm.the retention times were 2.956 and 3.538min for Duloxetine and Mecobalamin respectively. The injection volume was 20µl.as per ICH guidelines the method was validated and the method was found to be linear in the range of 20-80µg/ml for Duloxetine and Mecobalamin. Percent recovery studies of Duloxetine and Mecobalamin 98.00%and101.50%. The limit of detection and quantification was found to be 0.56&1.69µg/ml Duloxetine and 0.57&1.74µg/ml for Mecobalamin. The values of precession and robustness lie within the acceptance limit. Thus the proposed method can be successfully applied for simultaneous determination of Duloxetine and Mecobalamin in routine analysis work.
Authors and Affiliations
Jogi Naga Kumari
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