Validated Reverse Phase Hplc Method for Determination of Raltegravir in Pharmaceutical Preparations

A simple, rapid, selective, sensitive, linear, precise and accurate RP-HPLC method was developed and validated for the determination of raltegravir in bulk and in tablet dosage forms. Seperation of the drug was achieved on a reverse phase Symmetry C8 column (150mmx4.6mm I.D., 5 m particle size) at ambient temperature using a mobile phase consisting of phosphate buffer pH 2.5 and acetonitrile in the ratio of 40:60 v/v. Isocratic elution at a flow rate of 0.6 mL/min was employed. The UV detection wavelength was 247 nm and 20 μl of sample was injected. The linearity was found in the range of 5-25 μg/ml with a correlation coefficient of 0.999. The retention time for raltegravir was 2.881 min. The % recovery was within the range between 99.36 % and 101.85 %. The method was validated as per the ICH guidelines for its sensitivity, linearity, accuracy and precision. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was successfully employed for routine quality control analysis of raltegravir in bulk samples and its pharmaceutical formulations.