A Stability Indicating Method Development of Lopinavir and Rotinavir in Combined Tablet Dosage Forms by RP-HPLC

A new stability indicating RP-HPLC method was developed for simultaneous estimation of Lopinavir and Rotinavir in combined tablet formulations. Chromatography was carried out on a Kromasil C18 HPLC Column (250 x 4.6mm; 5μm) eluting with a mobile phase consisting of a 30:70v/v mixture of Phosphate buffer and acetonitrile at a flow rate of 1.0mL/minute. The wavelength detection was fixed at 220nm. Using standard addition method accuracy was assessed. The developed HPLC method was validated with respect to precision, specificity, accuracy, linearity and robustness. Forced degradation studies on the formulation were conducted by adopting the proposed method to assess the stability of the analytes under acid, base, peroxide, thermal and photolytic conditions and suitability of the method to resolve the degradation products.