Method development and validation for simultaneous estimation of lamivudine and raltegravir in pure drug form by RP-HPLC

A new, simple, accurate, and economical method was developed for simultaneous estimation of Lamivudine and Raltegravir by RP-HPLC. The chromatographic separation was achieved through Phenomenex C₁₈ 250mm × 4.6mm, 5μm as stationary phase and mobile phase was Methanol: Acetonitrile: Millipore Water (60:10:30) v/v ratio with the flow rate of 1ml/min at 292nm. The developed method was validated for the quantitative analysis of commercially available pure drugs. The instrument used was Shimadzu PDA-20AR, Lab solution software. The retention time for Lamivudine and Raltegravir were found to be 2.883 and 4.430 respectively. The linearity study of Lamivudine was performed by using concentration range of 1-20μg/ml and for Raltegravir concentration range was at 10-30μg/ml and correlation coefficient (r²) was found to be 0.999 and 0.9977 respectively. The developed method was validated in reference to ICH Guidelines. Specificity, Linearity, Accuracy, Robustness, Precision and Ruggedness obtained within the acceptance range.