Journal article Open Access

NEW HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF EMTRICITABINE IN MARKETED FORMULATION

Prabhat Tiwari, Dr. Alok Pal Jain, Vivek Shrivastava

A novel stability-indicating RP-HPLC method has been developed and validated for quantitative analysis of Emtricitabine in the bulk drug and in a pharmaceutical dosage form. An isocratic separation of EMT was achieved on Thermo C18 column (4.6 x 250mm, 5 μ particle size) as the stationary phase with a flow rate of 1 ml/min and using a UV detector to monitor the eluate at 254 nm. The mobile phase consisted of Acetonitrile: methanol (50:50v/v) enabled separation of the drug from its degradation products. The method was validated for linearity, accuracy (recovery), precision, specificity, and robustness. Linearity was established by least squares linear regression analysis of the calibration curve. The calibration curve was linear over the concentration range of 5-25μg/ml and correlation coefficients were found to be 0.999 for Emtricitabine respectively. Recovery studies were carried out by applying the method to drug sample to which known amount of Emtricitabine at three concentration levels of 80, 100% and120 % were added. At each level %recovery was determined, which are in the range of 98.67±0.406- 99.00±0.030%. The precision of the analytical method was studied by multiple sampling of the homogenous sample. The precision was done by measuring the absorbance for six times. The % RSD value was found to be 0.767, 1.224, 1.870 for repeatability, day to day and analyst to analyst respectively indicating that the method is precise. The forced degradation study prove the stability indicating power of the method and therefore, the validated method may be useful for routine analysis of Emtricitabine as bulk drug, in respective dosage forms, for dissolution studies and as stability indicating assay method in pharmaceutical laboratories and industries.

Keywords: RP-HPLC, Emtricitabine, Forced degradation, Method validation, repeatability

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