Monday , 21 September 2020

Method Development and Validation by RP-HPLC for the Simultaneous Estimation of Cinacalcet and Maxacalcitol in Tablet Dosage Form

N. Usha*, M. Gobinath, V. Hari Baskar, Ramesh Dhani, A. Soniya
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Muthukur, SPSR Nellore, A.P, India. 

A B S T R A C T
A Simple, selective, accurate, precise and linear RP-HPLC method was developed subsequently validated for estimation of cinacalcet in bulk & tablet dosage form. Gradient elution at a flow rate of 0.8 ml/min was used for separation of drugs in reversed-phase mode using Waters HPLC 22695 model on an INERTSIL ODS C18 column (150 x 4.6 mm; 5μ) at a ambient temperature. Mobile phase consisted of water: methanol: acetonitrile (20:60:20). The UV detection wavelength was 235 nm 20 μl was injected. The retention time for cinacalcet was 3.7 min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The % recovery was within the range between 99.73% and 99.85%. The method was validated as per the ICH guidelines.
Keywords: Cinacalcet, Maxacalcitol, RP-HPLC, validation

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