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TITLE:

METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR THE DETERMINATION OF LAMIVUDINE FROM DRUG LOADED NANOPARTICLE PHARMACEUTICAL FORMULATION

AUTHORS:

P. Pravalika Reddy, Dr. B. Madhava Reddy, Dr. D. Jaya Prakash, Dr. K. Latha

ABSTRACT:

Abstract: Lamivudine nanoparticles were prepared by Ionotropic pregelation method by optimizing the parameters like polymer concentration, stirring time and stirring speed. The optimized lyophilized nanoparticles were compressed into a tablet by direct compression method by varying the type and concentration of cushioning agent and disintegrant. MCC was showing more drug release compared to other cushioning agents. The prepared tablets were evaluated for pre compression and post compression properties. Among all the formulations, dissolution studies F8 formulation produced sustained release in comparison with the marketed Tablet and released 2.57% of drug in acidic PH (1.2) and 96.22% of drug in intestinal PH (6.8).The dissolution samples of F8 and marketed lamivudine tablet were estimated by the developed RPHPLC method by using Inertsil ODS 3V column,C18(150mm x4.6mm) 5µm, an isocratic mobile phase consists of Mixed phosphate buffer and ACN (60 : 40) at PH 4 with UV detection at 273nm where Lamivudine was eluted at 2.4 min. The developed method was validated according to ICH guidelines. The release kinetics of F8 formulation was found to be first order with Anomalous transport.Stability studies of F8 formulation showed good results.

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