Development and Validation of Stability-indicating RP-HPLC Method for Coumarin Assay in Bulk Drugs and Pharmaceutical Products
DOI:
https://doi.org/10.37285/ijpsn.2013.6.3.11Abstract
A simple, economic, selective, precise, rapid and reproducible stability indicating HPLC method for the analysis of coumarin (CMN) in bulk drugs and from pharmaceutical formulation has been developed and validated. Separation was achieved on a symmetry C18 column using a mobile phase consisting of a mixture of methanol:water in the ratio of (70:30%v/v) at a flow rate of 1ml/min with detection at 276 nm. Linear regression analysis data for the calibration revealed a good linear relationship between response and concentration in the range 2 μgml-1 to 14 μg ml1 of CMN; the correlation coefficient was 0.999. The LOD and LOQ were 30 and 100 ng ml-1 respectively. The method was validated for accuracy, precision, recovery, reproducibility, specificity, robustness and degradation studies. The statistical analysis showed the method to be precise, reproducible, selective, specific and accurate for analysis and estimation of coumarin in bulk drugs and pharmaceutical dosage forms.
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Keywords:
Coumarin, RP-HPLC, method validation, pharmaceutical dosage form
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References
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