Development and Validation of UV Spectroscopic Method for the Determination of Ranolazine in Bulk and Formulation
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To develop a new UV-Spectrophotometric method for the determination of Ranolazine in bulk and pharmaceutical dosage form.
The method was developed using 0.2% v/v ortho phosphoric acid as solvent after many trail and errors for determining the absorption maxima at 271 nm. Different dilutions ranging from 20 to 100μg/ml were prepared from stock solution (1mg/ml) solution and their absorbance was measured at 217 nm.
The developed method was validated according to ICH for different parameter like linearity, precision, Accuracy, robustness, ruggedness, LOD and LOQ. Result indicating that the validation parameters are within the limits, the correlation coefficient (r2) is found to be 0.999, % RSD value obtained by precision is 0.590,% recovery of the drug is 97.25–97.75%, LOD and LOQ values were found to be 0.807 and 2.4460μg/ml, y=0.006 x-0.0048 is the linear equation obtained from calibration curve, % RSD obtained by robustness was 0.00086, % purity obtained by assay was 101.01%.
From the results we concluded that the method can be used for the determination of Ranolazine in routine analysis in quality control of pure and pharmaceutical dosage form without the interference of excipients.
Ranolazine, UV-spectrophotometry, 0.2% v/v Ortho phosphoric acid, Method development, Validation.