Stability Indicating RP-HPLC Method Development and Validation for the Determination of Potential Degradation Impurities of Efavirenz, Emtricitabine and Tenofovir in Combined Pharmaceutical Dosage Form
Abstract
U. R. Maniyar1*, , K. Koshe1 M. V. Katariya3, G. S. Karva2, V. R. Katariya4, Sushil Jaiswal1
A simple, very accurate and precise stability indicating RP-HPLC gradient was developed to determine related substances of Efavirenz, Emtricitabine and Tenofovir disoproxil from tablet dosage form. The experiment was carried out on Zorbax SB-Phenyl, (250 mm X 4.6 mm), 5 μm column using the gradient composition of buffer pH 3.7 as mobile phase A and mixture of methanol, acetonitrile and tetrahydrofuran (50: 50: 2 v/v/v), degas as mobile phase B at flow rate 1.2ml/min and detection wavelength 265 nm The new proposed method was simple, accurate, precise, linear and rugged. Method was validated as per ICH guidelines1, 2, 3, 4 for simultaneous determination related substances of Efavirenz, Emtricitabine and Tenofovir disoproxil in tablet dosage form hence can be used for routine analysis.
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