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Abstract

STABILITY-INDICATING RP-HPLC METHOD FOR ANALYSIS OF EMTRICITABINE IN THE BULK DRUG AND IN A PHARMACEUTICAL DOSAGE FORM

Dr. Vivek Jain1, Pooja Prajapati*1, Prabhat Jain2

1NRI Institute of Pharmacy, Bhopal (MP)
2Scan Research Laboratories, Bhopal (MP)

ABSTRACT

A novel stability-indicating RP-HPLC method has been developed and validated for quantitative analysis of Emtricitabine (EMT) 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 10mM KH2PO4: methanol (20:80v/v) and pH adjusted 3.0 by orthophosphoric acid enabled separation of the drug from its degradation products. The method was validated for linearity, accuracy (recovery), precision, specificity, and robustness. The linearity of the method was satisfactory over the range5-25μg/ml (correlation coefficient 0.999). The limits of detection and quantification were 0.35 and 1.05μg/ml respectively. Recovery of EMT from the pharmaceutical dosage form ranged from 98.50 to 99.00%. EMT was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the samples were analyzed by this method. Extensive degradation was found under acid, photolytic and oxidative stress. The degradation products were well resolved from main peak. The forced degradation study proves the stability indicating power of the method and therefore, the validated method may be useful for routine analysis of EMT 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 validated.


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