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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR THE SIMULTANEOUS ESTIMATION OF EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE AND EFAVIRENZ IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Ashok Gorja*1, Sumanta Mondal2

1Department of Pharmaceutical Analysis & QA, Faculty of Pharmacy, Gland Institute of Pharmaceutical Sciences, Kothapet, Medak-502313, Telangana, India.

2Department of Pharmaceutical Chemistry, Faculty of Pharmacy, GITAM Institute of Pharmacy, GITAM University, Rushikonda, Visakhapatnam-530045, Andhra Pradesh, India.

ABSTRACT

A stability indicating method was developed for the simultaneous estimation of Emtricitabine, Tenofovir and Efavirenz in pharmaceutical dosage form by reverse phase high performance liquid chromatography (RP-HPLC) and validated. 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 Ammonium acetate and Acetonitrile in the ratio 65:35 (v/v/) and detected at the wave length 260nm. The retention times for Emtricitabine, Tenofovir and Efavirenz were found to be 2.28min, 4.03min and 2.79min respectively. The drugs obeyed Beer’s law in the concentration range of 50µg/mL to 300µg/mL, 150µg/mL to 900µg/mL and 75µg/mL to 450µg/ml 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: Emtricitabine, Tenofovir, Efavirenz, Stability indicating, Method development, Validation, RP-HPLC.


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