A novel, rapid and a stability-indicating reverse phase LC method has been developed and validated for the simultaneous estimation of darunavir and ritonavir in tablet dosage form. The chromatographic separation was achieved on a novel core shell technology C4 stationary phase of particle size 3.6 µ. The method employed a linear gradient elution and the detection wavelength was set at 240 nm. The mobile phases(s) consist of buffer, acetonitrile and tetrahydrofuran delivered at a flow rate of 0.5 ml per minute. Proposed method was extensively validated as per ICH guidelines. Regression analysis shows r value (correlation coefficient) of greater than 0.999 for individual active drug substances. The samples were assayed against a qualified reference standard and the mass balance was found to be close to 98.3%.
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