Thursday , 29 February 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Lamivudine and Raltegravir by RP-HPLC Method

B. Priyanka1, K. Sahithi1, G. Srihitha1, G. Vyshnavi1, Bijjiga Sravanthi2
1Bojjam Narasimhulu Pharmacy College for Women’s, Sayeedabad, Hyderabad, Telangana-500059.
2Research Associate, KP Labs, Kothapet, Hyderabad-500035

The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of Lamivudine and Raltegravir in tablet dosage form. The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The Sample recoveries in all formulations were in good agreement with their respective label claims. From literature review and solubility analysis initial chromatographic conditions Mobile phase ortho phosphoric acid buffer: Acetonitrile 40:60 were set (Buffer PH 2.45 adjusted with Triethylamine), Symmetry C18  (250×4.6mm, 5µ) Column, Flow rate 1.0 ml/min and temperature was ambient, eluent was scanned with PDA detector in system and it showed maximum absorbance at 260nm. As the methanol content was increased Lamivudine and Raltegravir got eluted with good peak symmetric properties. The retention times for Lamivudine and Raltegravir was found to be 2.335 min and 3.400 min respectively. System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between 50% to150 % levels, R2 value was found to be as 0.999. By using above method assay of marketed formulation was carried out, 100.7% was present. Full length method was not performed; if it is done this method can be used for routine analysis of Lamivudine and Raltegravir.

Keywords: HPLC, Ortho Phosphoric Acid, Acetonitrile, Symmetry C18, Lamivudine, Raltegravir

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