Objectives: The aim of this present study is to develop an accurate, precise and linear Reverse-phase High-performance Liquid Chromatographic (RPHPLC) method for the estimation of raltegravir potassium in the bulk and pharmaceutical dosage form. Methods: The chromatographic system employs a reverse phase shim-pack C18 column, (150 x 4.6 mm; 5 μ) using the mobile phase acetonitrile: (0.05 M) ammonium acetate buffer, (pH -4 adjusted with glacial acetic acid) in the proportion of 50:50 v/v, delivered at a flow rate of 0.8 ml/min with the detection wavelength of 271 nm. Results: The developed method resulted in the retention of raltegravir at 4.31 min. Raltegravir potassium exhibited linear relationship (r2> 0.9999) over the analytical range 10-50 μg/ml. The precision was exemplified by a relative standard deviation of 1.60 %. The percentage recovery was found to be in the range of 100-102 %, during accuracy studies. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) was found to be 0.104 μg/ml and 0.315 μg/ml, respectively. Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of raltegravir potassium in (20 mg, 50 mg) tablet as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.
Key words: RP-HPLC, Method Development, Method optimization, Validation, Raltegravir potassium.