Development and Validation of Stability Indicating Method for the Simultaneous Quantification of Emtricitabine, TenofovirDisoproxilFumarate and Rilpivirine Hydrochloride in Pharmaceutical Dosage Forms by RP-HPLC
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2018, Vol 4, Issue 2
Abstract
Abstract:A stability indicating method was developed and validated for the simultaneous quantification of Emtricitabine, Tenofovir and Rilpivirine in pharmaceutical dosage form by reverse phase high performance liquid chromatography (RP-HPLC). The chromatographic separation was performed using the Kromasil C18 (250mm × 4.6mm, 5µ) column run in an isocratic mode with a flow rate of 1mL/min at ambient temperature. The mobile phase consists of 0.01N Potassium dihydrogen phosphate and Acetonitrile in the ratio 65:35 (v/v/) and detected at the wave length 279nm. The retention times for Emtricitabine, Tenofovir and Rilpivirine were found to be 4.35min, 2.05min and 3.61min respectively. The drugs obeyed Beer’s law in the concentration range of 50µg/mL to 300µg/mL for Emtricitabine, 75µg/mL to 450µg/ml for Tenofovir and 6.25µg/mL to 37.5µg/mL for Rilpivirine respectively. The method was validated as per ICH guidelines for accuracy, precision, specificity, ruggedness, robustness and stability. The standard solution was subjected to stress conditions such as acidic, basic, oxidative, neutral, photolytic and thermal conditions. The net degradation was found to be within the limits. Keywords:Development and Validation, Emtricitabine, Rilpivirine hydrochloride, RP-HPLC Stability indicating method, TenofovirDisoproxilFumarate.
Authors and Affiliations
Gorja Ashok, Sumanta Mondal
Keywords
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